Senior Manager, Clinical Data Management
Senior director job at Crinetics Pharmaceuticals
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Senior Manager, Clinical Data Management, will be responsible for all clinical data management activities and deliverables for the assigned study/studies in accordance with ICH/Good Clinical Practices (GCP), GDCMP and other relevant regulations, procedures and guidelines. The responsibilities of this position include but are not limited to vendor service oversight, vendor invoice verification, budget contract negotiations and management, being the subject matter of expert of data management to provide guidance and suggestions to vendor and the study team for all data management deliverables and timelines from study start-up through study close-out, final reporting, and data archiving.
The Senior Manager will be involved in development of SOP(s), data standards and standardization, managing and leading the ongoing practices in DM processes with internal study resources and/or vendors for the responsible study/studies and driving for DM operation excellence.
The Senior Manager will also partner with other functional groups and external vendors to ensure timelines and the quality of data deliverables of the responsible study/studies.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
Manages the assigned study/studies and makes expert recommendations and/or decisions that assure timelines, deliverables and data quality.
Collaborates cross-functionally to resolve clinical data issues and ensure effective communication throughout the drug development process.
Resolves and/or escalates issues encountered at the study level and ensures the performance of the data management function.
Provides effective CRO/vendor oversight to ensure requirements are met and the project plans are executed to meet the development needs.
Leverages data management and related expertise to promote best practices across the drug development lifecycle and enhances collaboration with relevant stakeholders.
Contributes to team building and best practice to achieve the defined data quality with cost efficiency.
Participates in regulatory audit and/or company initiatives.
Education and Experience:
Required:
MS/BS in life sciences or related field
7 + years of direct data management experience and at least 3 years of CRO oversight experiences
In depth knowledge of clinical data management in the Biotech, Pharmaceutical or CRO industry.
Strong project management skills and experiences working with CROs/vendors
Demonstrated organizational and interpersonal skills.
Detail oriented with excellent communication skills and extensive experiences working in cross-functional setting.
Highly knowledgeable and experienced in CDISC standards, SDTM requirements, and CFR-Part 11 Compliance
Knowledge of GCP, ICH and other regional regulations and compliance
Experiences with clinical data lifecycle from database set-up and maintenance to database lock and archiving
Working knowledge of current technologies in clinical trial data collection systems.
Preferred:
Knowledge in current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT).
Competence in Excel and/or SAS programming is a big plus
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel:
You may be required to travel for up to 5% of your time.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Salary Range
The salary range for this position is: $149,000 - $185,000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
Auto-ApplyAssociate Director, Consumer Marketing - OTC (Eye Care)
Irvine, CA jobs
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
The Associate Director, Consumer Marketing serves as the patient, brand, and product subject matter expert for Over-The-Counter (OTC) consumer business, driving overall brand performance through strategic, data-driven marketing across varied channels. Lead cross-functional collaboration and external agency management, implementing eCommerce strategies to bolster online reach, and consumer engagement.
Key Responsibilities
Lead brand strategy evolution, including value proposition, positioning, segmentation, and omni-channel strategy, with integration of eCommerce.
Direct development and execution of creative consumer marketing tactics and omnichannel campaigns-including TV, digital, social, website, CRM, and eCommerce platforms.
Collaborate extensively with external agencies and a broad range of internal stakeholders to ensure consistency, compliance, and excellence in brand messaging and marketing execution.
Drive brand annual planning, representing direct-to-consumer (DTC) needs foremost, while ensuring digital commerce initiatives are incorporated as supportive growth channels.
Oversee measurement, analytics, and optimization of marketing performance. Utilize KPIs for continuous campaign improvement and innovation.
Support business development opportunities, leverage digital and eCommerce data insights, and provide ad hoc competitive analyses as needed.
Advise senior leadership on market challenges and opportunities, offering creative thought leadership for consumer marketing and eCommerce initiatives.
Qualifications
Bachelor's Degree required.
Proven marketing experience with increased proficiency in all marketing skills.
Previous cross franchise/cross channel marketing experience preferred.
Preferred Qualifications
BA/BS required; MBA preferred.
8+ years of consumer marketing experience with a strong preference for pharma and CPG experience; eCommerce expertise is valuable.
Deep knowledge of brand management, omni-channel approaches, and campaign development.
Track record of managing multi-agency partnerships and influencing across a matrixed organization.
Strategic thinker with strong planning, organization, attention to detail, and execution skills.
Intellectual curiosity and ability to generate new ideas for consumer engagement and growth-across both traditional and digital touchpoints.
Experience with financial planning, campaign metrics, and business analysis is a plus.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at thetime of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Marketing Director
Raleigh, NC jobs
Marius Pharmaceuticals is a patient‑centric healthcare company developing therapies for hypogonadism (Testosterone Deficiency). We focus on optimizing metabolic function, healthspan, and longevity, while addressing the burdens associated with Testosterone Deficiency through rational, practical, and innovative solutions.
We are best known for KYZATREX , an FDA-approved oral testosterone therapy, designed to redefine how Testosterone Deficiency is treated. As a company, we thrive at the edge of innovation, moving quickly and decisively to change the standard of care and put patients first.
For more, visit mariuspharma.com.
Position Overview
We are seeking a fast-moving, creative, and impact-driven Marketing Director to join our leadership team. This is a role for a builder-not a maintainer. The ideal candidate thrives in ambiguity, embraces a “run fast, break stuff, fix it better” mindset, and knows how to cut through complexity to deliver results.
As an individual contributor and leader, you will move at startup speed to drive awareness, growth, and adoption of KYZATREX and Testosterone Deficiency as a critical health issue. You will set bold strategies, experiment rapidly, and execute with precision-balancing the discipline of a regulated industry with the urgency of a category-defining product.
Primary Responsibilities
• Run fast & drive impact: Execute bold marketing strategies with urgency-prioritizing outcomes over bureaucracy.
• Build the category: Create massive awareness for Testosterone Deficiency and Testosterone as a metabolic hormone.
• Position KYZATREX as #1: Make oral testosterone the default choice by highlighting its clear advantages over injections and creams.
• Story tell at scale: Generate powerful content-video, audio, text, mixed media-that resonates with patients, physicians, and partners.
• Leverage voices of authority: Activate senior management, patient advocates, and KOLs to amplify credibility and reach.
• Experiment relentlessly: Test and learn across earned, owned, and paid channels- SEO, SEM, social, email, PR-with rapid iteration.
• Demand data: Track KPIs obsessively, optimize campaigns on the fly, and report actionable insights to leadership and the board.
• Collaborate, but push: Work with sales, regulatory, operations, and finance-but drive forward with urgency even when rules slow others down.
• Expand reach: Identify new market opportunities (domestic & international) and move fast to capture them.
What We're Looking For
• A proven growth marketer who has built audiences and driven measurable results in high-stakes or regulated industries.
• 7+ years of progressive marketing leadership, ideally including pharma, biotech, or consumer health.
• Fluent in digital and social media platforms, with the ability to move from strategy to execution in the same day.
• A creative disruptor who thinks beyond templates and finds new ways to win attention and loyalty.
• Strong business acumen with the confidence to challenge assumptions and make tough calls.
• Relentless bias for action-you move fast, adjust faster, and get things done.
Why Join Us
At Marius, you won't just market a product-you'll redefine a category. This is a role for someone who wants to leave a mark, move quickly, and help build a company from the ground up.
Equal Employment Opportunity Statement
Marius Pharmaceuticals is an equal-opportunity employer. We provide equal employment opportunities to all employees and applicants without regard to race, color, religion, gender, sexual orientation, gender identity, pregnancy, childbirth or related medical conditions, age, veteran status/military status, disability, genetic information, or any other protected characteristic. This policy extends to all terms and conditions of employment.
Senior Director, Global Clinical Development - Nephrology & Immunology
Baton Rouge, LA jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development - Nephrology & Immunology
Sacramento, CA jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development - Nephrology & Immunology
Tallahassee, FL jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development - Nephrology & Immunology
Montgomery, AL jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Sacramento, CA jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Clinical Development - Nephrology & Immunology
Atlanta, GA jobs
**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.
**Culture**
As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed.
Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.
**Pipeline**
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
You can learn more about Otsuka by clicking here! (*******************************************
****
**Position Summary**
Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP).
The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.
The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.
**Key Job Responsibilities**
+ Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions.
+ Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation.
+ Serve as the medical lead and subject matter expert for assigned indications.
+ Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes.
+ Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
+ Collaborate with regulatory affairs on interactions with global health authorities.
+ Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
+ Lead clinical discussions with KOLs and advisory boards.
+ Develop clinical documents including medical monitoring plans, asset development plans
+ Contribute to development of publication plans and review scientific manuscripts for publications.
+ Mentor and provide leadership to junior team members within the organization.
+ Support business development activities through medical due diligence and evaluation of external opportunities.
+ Contributes to corporate initiatives by participating in continuous process improvement to meet company
**Knowledge, Skills, Competencies, Education, and Experience**
Required:
+ A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
+ Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
+ Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing).
+ An advanced understanding of clinical medicine and science.
+ Advanced understanding of drug development principles and clinical trial implementation and management.
+ Complete understanding of the global regulatory requirements.
+ Working knowledge of marketing and commercialization.
+ Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
+ Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies,
+ Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
+ Ability to work across different therapeutic areas and different stages of clinical development.
+ Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants).
+ Strong communication and presentation skills.
+ Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
+ Knows how/when to apply organizational policy or procedures to a variety of situations.
+ An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including:
+ Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
+ Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
+ Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
**Physical Demands and Work Environment**
+ Travel (~30-35%)
+ See document Physical Demands and Work Environment for further requirements.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Baton Rouge, LA jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Montgomery, AL jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications, Nephrology & Immunology
Montgomery, AL jobs
The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy.
The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team)
+ Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
+ Consider technology and AI to support workflow improvement
+ Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development.
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus
**Skills and Competencies:**
+ Strong ability to present to executive leadership team
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
+ Knowledge of digital platforms and tools for medical content delivery and engagement
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications, Nephrology & Immunology
Tallahassee, FL jobs
The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy.
The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team)
+ Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
+ Consider technology and AI to support workflow improvement
+ Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development.
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus
**Skills and Competencies:**
+ Strong ability to present to executive leadership team
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
+ Knowledge of digital platforms and tools for medical content delivery and engagement
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Tallahassee, FL jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications, Nephrology & Immunology
Atlanta, GA jobs
The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy.
The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team)
+ Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
+ Consider technology and AI to support workflow improvement
+ Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development.
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus
**Skills and Competencies:**
+ Strong ability to present to executive leadership team
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
+ Knowledge of digital platforms and tools for medical content delivery and engagement
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Medical Communications CNS
Atlanta, GA jobs
The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy.
The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community.
****
**Key Responsibilities:**
**Global Scientific Communication Strategy**
+ Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy
+ Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment
+ Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements
+ Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models
**Content Development Oversight**
+ Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to
+ Scientific Communications Platform (SCP)
+ Global Publications Strategy
+ Global Medical Publications Plan
+ Core Disease State Deck
+ Core Field Materials
+ Medical Publications
+ Integrated Medical Communications Planning
+ New Data Reporting
+ Medical Information Content Generation
**Publications Strategy**
+ Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals
+ Direct agency and vendor relationships to deliver high quality publication deliverables
**Congress Planning**
+ Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs)
+ Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles
**Medical Information Content Generation:**
+ Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents.
+ Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements.
+ Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels.
+ Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies.
+ Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery.
+ Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement.
+ Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization.
+ Consider technology and AI to support workflow improvement
**Cross-Functional Leadership**
+ Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions
+ Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy
+ Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education
+ Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function
**Qualifications**
**Education and Experience:**
+ Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field
+ Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry
+ Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function
+ Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas
+ Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale
+ Previous experience overseeing or leading medical information groups is a plus.
**Skills and Competencies:**
+ Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level
+ Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making
+ Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress)
+ Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Quality Solutions
Sacramento, CA jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Quality Solutions
Tallahassee, FL jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Quality Solutions
Atlanta, GA jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Senior Director, Global Quality Solutions
Montgomery, AL jobs
- Aligning with the strategic goals of the GQ organization, the Sr. Director of Global Quality Solutions (GQS) is responsible for understanding and driving efficiency across Global Quality's processes and operations via automation and digitization; serving as an enabler of transformation across existing GQ systems, future processes and teams.
- The Sr. Director position will facilitate continuous improvement activities within GQ leading special pilots, prototypes, collaborations and projects to digitalize the Knowledge and Document management processes.
- The Sr. Director of GQS liaises with applicable business functions (i.e., Otsuka Data Sciences, Otsuka Information Technology, Applied Innovation and Process Improvement, etc.) to advance the digital transformation of the entire GQ workspace (across GXP) via the optimization of applicable systems and workflows, the adoption of automation, and the promotion of a GQ culture driven by state-of-the-art data insights.
- The Sr. Director brings industry best practices from a variety of disciplines and solutions (i.e., quality, automation, machine learning, and artificial intelligence, etc.) to deliver a strategic roadmap that will bring and maintain Otsuka's Quality Knowledge and Document Management practices to a best in class - digitalized landscape.
Key job responsibilities
- Develop a roadmap to drive Knowledge Management to an automated, digitized and ever-green environment
- digitalizing the processes and practices of Document Management (i.e. Iron Mountain) and eliminating (or significantly minimizing) any paper archive.
- Applying technology intelligence and understanding of the process enhancement requirements, determine opportunities for optimization of existing systems and identifying the need for new solutions
- Addressing digitization of paper documents across the ecosystem of GQ to enable e-archiving and e- access and retrievability.
- Design and employ a digital and automated GQ work flow across the enterprise of the GQ business function.
- Drive a culture of Quality Innovation awareness
- Benchmarking external opportunities and innovation advancements and ensuring Otsuka GQ is at the cutting edge of the use of innovative processes, practices, solutions and technology to drive optimal operational efficiency and effectiveness.
- Collaborate with external parties to understand the current industry landscape and endorse/apply best in class practices and solutions to Otsuka GQ system portfolio and business operations.
- Lead the design and execution of complex GQ optimization initiatives; including - detailed program planning, well-defined business cases, clear value proposition, the management of applicable collaborators and identification/leveraging of applicable external expertise.
- Evaluate, measure and document time, resource and cost optimizations of continuous improvement and transformational activities to ensure improved efficiency and effectiveness over time.
- Identify and pursue opportunities through internal and external collaborations to optimize Knowledge and Document Management, GQ processes, the timeliness and quality of GQ deliverables, and GQ resource requirements using transformational technologies such as, Robotics Process Automation, Machine Learning, Artificial Intelligence and Blockchain capabilities.
- Travel (approximately 10-25%)
Qualifications
- Advanced degree required (e.g., MS, MPH, NP, PhD, MD etc.) with a minimum of 5 years of applicable health care, technology or industry is experience strongly preferred.
- Advanced analytic skills, and general understanding of the drug development and regulatory process.
- Successful track record of leadership and timely delivery of innovative business deliverables.
- Strong communication, interpersonal and alliance management skills; possessing the ability to credibly, knowledgeably and effectively represent and communicate initiatives to internal and external KOLs/stakeholders, various stakeholders in the medical/healthcare community, Otsuka's partners and clinical trial personnel.
- Understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka's competitive edge.
- Ability to work effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
- Strong project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $205,368.00 - Maximum $307,050.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.