Clinical Director jobs at PharMerica - 35 jobs

We are seeking a Medical Director in Pyschiatry to join our dynamic team in Cincinnati, Ohio. The Medical Director has overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required. We are currently seeking Medical Directors in all Therapeutic Areas. * All Medical Directors receive hybrid, work from-home flexibility. This role also has the ability to be fully remote-based with the right experience. Responsibilities * Provide medical management and expertise for clinical trials; * Contribute medical expertise to study reports, regulatory documents, and manuscripts; * Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials; * Participate in new business development through involvement in proposal and sponsor meetings as requested; * Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents; * Follow specific research related protocol and lead others in strict adherence to the policies. Qualifications * Must have an M.D., specialization in Psychiatry * Must be eligible to obtain a medical license * Board certification preferred * Prior clinical trial research experience preferred * Previous experience in pharmaceutical-related clinical research is preferred. Travel: up to 20% at times Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

We are seeking a Medical Director with clinical specialization (varying therapeutic areas including, but not limited to, Immunology/Allergy, Psychiatry, GI/Nephrology, Cardiology and more) to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required. All Medical Directors have hybrid WFH flexibility. This role also has the ability to be fully remote with the right experience. Responsibilities * Provide medical management and expertise for clinical trials; * Contribute medical expertise to study reports, regulatory documents, and manuscripts; * Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials; * Participate in new business development through involvement in proposal and sponsor meetings as requested; * Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents; * Follow specific research related protocol and lead others in strict adherence to the policies. Qualifications * Must have an M.D., with a therapeutic area specialization * Must be eligible to obtain a medical license * Board certification preferred * Prior clinical trial research experience preferred * Previous experience in pharmaceutical-related clinical research is preferred. Travel: up to 20% Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

We are seeking a Nephrologist- Medical Director to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required. We are currently seeking Medical Directors in all Therapeutic Areas. All Medical Directors have hybrid WFH flexibility. This role also has the ability to be fully remote with the right experience. Responsibilities * Provide medical management and expertise for clinical trials; * Contribute medical expertise to study reports, regulatory documents, and manuscripts; * Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials; * Participate in new business development through involvement in proposal and sponsor meetings as requested; * Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents; * Follow specific research related protocol and lead others in strict adherence to the policies. Qualifications * Must have an M.D., specialization in Nephrology * Must be eligible to obtain a medical license * Board certification preferred * Prior clinical trial research experience preferred * Previous experience in pharmaceutical-related clinical research is preferred. Travel: up to 20% Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

We are seeking a Medical Director in Pulmonology to join our dynamic team in Cincinnati, Ohio. The Medical Director has overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required. We are currently seeking Medical Directors in all Therapeutic Areas. * All Medical Directors receive hybrid, work from-home flexibility. This role also has the ability to be fully remote-based with the right experience. Responsibilities * Provide medical management and expertise for clinical trials; * Contribute medical expertise to study reports, regulatory documents, and manuscripts; * Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials; * Participate in new business development through involvement in proposal and sponsor meetings as requested; * Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents; * Follow specific research related protocol and lead others in strict adherence to the policies. Qualifications * Must have an M.D., specialization in Pulmonology * Must be eligible to obtain a medical license * Board certification preferred * Prior clinical trial research experience preferred * Previous experience in pharmaceutical-related clinical research is preferred Travel: up to 20% at times Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

We are seeking an Gastroenterologist/Hepatologist to join our dynamic team. The Medical Director will have overall responsibility for providing medical, scientific, and strategic leadership for the successful planning, execution, and reporting of clinical trials. Additionally, this role acts as the Medpace internal medical expert and will serve as a medical resource for the review, presentation, and interpretation of results in the Clinical Study Report. The Medical Director will also be involved in the development of new clinical projects, including study design, protocol, and project plans as required. We are currently seeking Medical Directors in all Therapeutic Areas. All Medical Directors have hybrid WFH flexibility. This role also has the ability to be fully remote with the right experience. Responsibilities * Provide medical management and expertise for clinical trials; * Contribute medical expertise to study reports, regulatory documents, and manuscripts; * Manage safety issues in clinical trials and work closely with associates in evaluation and assessment of the trials; * Participate in new business development through involvement in proposal and sponsor meetings as requested; * Coordinate with other departments in all phases of the studies and trials including feasibility assessments, design processes, educational efforts, management of medical information, and reviewing and editing of medical documents; * Follow specific research related protocol and lead others in strict adherence to the policies. Qualifications * Must have an M.D., specialization in Gastroenterology * Must be eligible to obtain a medical license * Board certification preferred * Prior clinical trial research experience preferred * Previous experience in pharmaceutical-related clinical research is preferred. Travel: up to 20% Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

**Medical Director - Gastroenterology Specialty** **About This Opportunity** Parexel is seeking an exceptional **Medical Director** with specialized expertise in **Gastroenterology** to join our Medical Sciences team. This is an outstanding opportunity for a physician looking to leverage their clinical expertise in the dynamic field of clinical drug development. As a medical expert and strategic partner, you'll play a pivotal role in advancing therapeutic innovations while building meaningful relationships with pharmaceutical sponsors and contributing to life-changing treatments for patients worldwide. **What You'll Do** **Lead Medical Excellence in Clinical Trials** + Serve as **Medical Monitor** for gastroenterology studies, ensuring scientific integrity and patient safety + Provide expert medical oversight throughout the clinical trial lifecycle-from protocol development through study completion + Review and approve critical study documents including protocols, Medical Monitoring Plans, safety reports, and Informed Consent Forms + Conduct real-time medical data review, evaluate protocol deviations, and ensure medical accuracy across all study deliverables **Drive Client Success & Relationships** + Build and maintain consultative relationships with pharmaceutical sponsors + Deliver medical expertise during client meetings, bid pursuits, and proposal development + Provide therapeutic area training to study teams and site personnel + Respond to complex medical and protocol-related questions from sites and study teams **Shape Drug Development Strategy** + Participate in early engagement activities and feasibility assessments + Contribute medical insights to protocol design and drug development programs + Support pharmacovigilance activities including medical review of serious adverse events + Provide risk assessments for clinical trial sponsorship **Collaborate & Innovate** + Work in a dynamic matrix environment with cross-functional project teams + Support business development initiatives with your gastroenterology expertise + Contribute to thought leadership through white papers, publications, and training modules + Participate in emergency medical contact rotations as needed **What You Bring** **Required Qualifications** + **MD, DO, or equivalent medical degree** with clinical practice experience + Active or prior medical licensure, or equivalent comparable clinical training + Strong understanding of clinical medicine and patient care principles **Preferred Experience** + Past experience as a **Physician in Industry** or as a **Clinical Trial Investigator** + Experience with **medical monitoring** and clinical trial design/execution + Knowledge of drug safety and pharmacovigilance processes **Essential Skills** + **Exceptional communication skills** - both written and verbal medical communication + **Client-focused mindset** with excellent interpersonal abilities + **Superior time management** and ability to prioritize multiple projects + **Attention to detail** with strong analytical and critical thinking capabilities + **Collaborative approach** and comfort working in matrix teams + **Flexibility and adaptability** to evolving project needs + Proficiency in written and spoken English **Why Parexel?** At Parexel, you'll join a global leader in clinical research with a mission to improve global health. We offer: + **Meaningful Impact:** Contribute to therapies that change patients' lives + **Professional Growth:** Expand your expertise across therapeutic areas and drug development phases + **Collaborative Culture:** Work with world-class medical and scientific professionals + **Flexibility:** Remote work arrangement with work-life balance + **Innovation:** Access to cutting-edge clinical research and medical technologies **Ready to Make a Difference?** If you're a gastroenterology specialist passionate about advancing medical science and improving patient outcomes through clinical research, we want to hear from you. **Apply today and help shape the future of drug development.** \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Manager, Clinical Operations works closely with the OPDC Monitoring Oversight Lead to manage monitoring oversight activities including managing Clinical Monitoring Consultants (CMC) contracted to perform monitoring oversight duties as well as escalating issues related to CRO monitoring quality. While focusing on quality and compliance, uses metrics and key performance indicators to drive monitoring oversight activities to achieve timelines and deliverables across the portfolio. Additionally, the Manager, Clinical Operations will support planning, resourcing, contracting, and budgeting of CMC resources to conduct monitoring oversight tasks. The Manager, Clinical Operations will also coordinate reporting and review of CRO related Key Performance Indicators (KPIs) Monitoring Oversight Lead. **Job** **Description** - Manage Monitoring Oversight activities in North America, and other regions as assigned - With the OPDC Monitoring Oversight Lead, plan conduct of Oversight Accompanied Visits (OAV) in the assigned region(s) - Manage, onboard, train and evaluate CMC resources to perform monitoring oversight tasks - Ensure adherence to training requirements for assigned CMCs (SOPs and study specific training) - Report status and output of OAVs and other monitoring oversight activities to OPDC Oversight Lead - Review OAV reports and manage timelines and deliverables - Oversee FSP monitoring resources in assigned region(s) as applicable - Support implementation and improvement of monitoring oversight related processes - Ensure compliance with Otsuka policies and procedures and applicable Key Performance Indicators (KPIs) - Provide oversight of required metrics across all monitoring oversight service providers and contribute to monthly reporting of monitoring oversight related KPIs to CM&O Management - Conduct Assessment Visits of CMCs to assess quality and compliance with applicable policies and procedures per the monitoring oversight job aids - Escalate significant issues related to oversight visits (e.g., site, study, CRA, etc.) in a timely manner to the Monitoring Oversight Lead, Clinical Operations management, and Study Management as applicable - Ensure compliance with clinical systems use and updates - Provide support for internal audit and regulatory inspection activities as applicable - Review study specific monitoring plans and provide feedback prior to implementation - Collaborate with CMC staffing vendors, as applicable - Manage consultant CMC contracts, budgets, and expenses to meet forecasts and support the development of annual regional monitoring oversight budget - Other monitoring oversight activities as assigned by OPDC Oversight Lead **Qualifications/** **Required** Knowledge/ Experience and Skills: - Experience managing field-based Clinical Research Associates. - Demonstrated ability to lead teams. - Proficient with on-site monitoring activities (Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visit, and Close Out Visit). - Demonstrated strengths with critical thinking and analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills. - Ability to supervise, direct and lead team members as well as interact with other internal staff and external vendors. - Strong planning and organization skills with the ability to multi-task and plan activities are they relate to field monitoring operations. - Both working and theoretical knowledge of ICH GCP Guidelines, FDA CFR, PhRMA code, site management, and regulatory compliance. - Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with team members, outside vendors and consultants. - Possess advanced computer skills (e.g., Microsoft applications, etc. - Financial management skills as applicable to oversee initiatives and system expenditures. - Ability to handle and prioritize multiple tasks. - Ability to work effectively in a team/matrix environment. - Ability to travel up to 30% including ground and air travel. Educational Qualifications - 7 years of industry experience and a minimum BA/BS Life Sciences, or equivalent college program, is required. **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 $107,718.00 - Maximum $161,000.00, 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.

**Parexel** is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values, Patients First, Quality, Respect, Empowerment & Accountability. **Parexel is looking for a Medical Director with a very strong background in Ophthalmology to join our Global Medical Sciences team.** **The role is remotely based in the US.** The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians. Primary activities will focus on **Medical Monitoring Delivery & PV Support** . The medical monitor will independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). **Medical Expertise** and experience in **Ophthalmology** is essential to the medical monitor role and will be manifested in high quality consultation on protocol development or drug development programs, medical review of various documents, collaboration on internal therapeutic area meetings, training module development, white papers, slide sets, publications etc. **Client Relationship Building & Engagement,** including soliciting and addressing client feedback and suggestions regarding medical study-related activities, are core skills required of the medical monitor. **Business Development:** the medical monitor will provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings. **Skills** + Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts + Client-focused approach to work + Excellent time management skills + Excellent verbal and written medical communication skills + Excellent standard of written and spoken English + A flexible attitude with respect to work assignments and new learning + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail + Willingness to work in a matrix environment and to value the importance of teamwork. **Knowledge And Experience** + Experience in clinical medicine (general or specialist qualifications) with Fellowship or specialty training in **Ophthalmology** , which is expected to be kept up to date. + A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution, preferred + Clinical practice experience + Good knowledge of the drug development process including drug safety, preferred + Experience in Pharmaceutical Medicine, preferred + Experience leading, mentoring and managing individuals/ a team, preferred **Education** + US Board certified in **Ophthalmology** + Experience as a Physician in Industry or as a clinical trial investigator is required + Previous CRO experience is strongly preferred + Medically qualified in an acknowledged medical school with completion of at least basic training in clinical medicine (residency, internship) The ability to travel 15% domestically or internationally is required. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

During the last five years, Parexel has participated in more than 1,000 Oncology and Hematology clinical projects. The range of services includes compound clinical development planning, collaboration with feasibility, protocol writing or optimization, medical monitoring and pharmacovigilance. Parexel has global presence in every phase of clinical research and expertise in virtually every indication and mechanism of action, including novel Immuno-oncology agents, cellular based therapy, and cancer stem cell targeted treatment. Join our growing team of Oncologists/Hematologists and make a difference in the lives of patients searching for more effective and better tolerated cancer therapies. **Parexel's continued success has positioned us for significant North American growth in the coming year. As we prepare for this expansion, we're seeking to connect with Board-Certified Oncologists who are passionate about advancing clinical research and interested in learning more about the Medical Director role.** As a **Medical Director** at Parexel, you will provide medical monitoring for assigned projects, function as medical representative on the project team, provide medical consultation as required or requested to client/sponsor or to other Parexel service groups, and assume the role of Senior Technical Lead in selected circumstances. **In addition, you will also:** + Review all individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness. + Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis, summarizing adverse experiences as required by FDA or the sponsor, depending on the contract. + Review data listings of safety data, including adverse experiences, laboratory data, and vital signs data, to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the project team, sponsor, investigator, and FDA. + Review documents written by various Parexel divisions for safety issues. + Review coding of adverse events and concomitant medications for accuracy and consistency. + Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors or in conjunction with clients/sponsors and in conjunction with other Parexel divisions. + Attend and present material, as requested, at meetings within Parexel as well as extra-company external meetings and conferences Successful applicants will be medically qualified based on successful completion of training at an accredited medical school and be US or Canada Board-certified in Oncology with experience in adult or pediatric clinical patient care. Past experience as a Medical Monitor, Physician in Industry, or as a Clinical Trial Primary Investigator or Sub-Investigator is highly preferred. **Successful applicants will also have:** + Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts. + Excellent time management skills + Excellent verbal and written medical communication skills + Excellent standard of written and spoken English + A flexible attitude with respect to work assignments and new learning + The ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. + A willingness to work in a matrix environment and to value the importance of teamwork. + The ability to travel 10% domestically and/or internationally as needed. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Job Description Preferred locations: Cleveland or Detroit Reporting to the Field Medical Director, Medical Affairs, the Medical Science Director performs a vital role within the organization by bridging internal strategy with external medical insights. Through interactions with the healthcare community, the Medical Science Director supports disease awareness activities, participates in scientific exchange, and obtains valuable information regarding unmet medical needs and current treatment paradigms to help guide executive decisions. As part of an emerging US and global organization, the Medical Science Director will also make significant contributions to processes, procedures, and best practices within the developing organization, serve as a medical resource to healthcare providers, clinical investigators and healthcare decision makers regarding the organization's investigational and marketed products, and support product commercialization. Key responsibilities include: Develop enduring professional relationships with healthcare practitioners, clinical investigators, and healthcare decision makers to stay abreast of current scientific and disease management trends. Provide medical and scientific support for Mitsubishi Tanabe Pharma America's (MTPA's) marketed products and areas of therapeutic interest. Gather insights regarding unmet medical needs and treatment landscapes in targeted therapeutic areas. Attend and support scientific and medical meetings. Disseminate clinical and competitive insights within the organization and prepare post-meeting deliverables as needed. Respond to unsolicited requests; provide truthful, non-misleading and non-promotional information regarding MTPA's products to healthcare professionals including physicians, hospital and MCO practitioners and formulary committees, pharmacists, nurse practitioners, physician assistants, dietitians and others. Assist in the development of educational materials and standard responses to frequently asked questions (FAQs); provide product-related site education; serve as medical resource for home office and field colleague training. Present medical and scientific information to healthcare professionals who provide peer education. Support Investigator Sponsored Trials (ISTs) as needed. Ensure that all medical education activities are conducted in full compliance with relevant guidance, rules and regulations. Depending on organizational needs, the Medical Science Director may also be asked to: Support medical initiatives across other therapeutic areas relevant to licensing, translational and clinical development activities. Collaborate with colleagues from Mitsubishi Tanabe Pharma Development America (MTDA) and Mitsubishi Tanabe Pharma Corporation (MTPC, Japan) to support product development activities, including evaluation of target indications and identification of clinical investigators. Qualifications Education: Required: Advanced Degree in Life Sciences: MD, PharmD or PhD. Preferred: MBA Professional Experience: Minimum of 7 years of industry experience (Pharmaceutical, Biotech or related field), including 3+ years of field medical experience, preferably as a Medical Science Liaison (MSL). CNS experience required, preferably in the area of motor neuron disease or neurodegenerative disorders. Experience with customer relationship management required, including thought leader development, speaker bureau training, and formulary presentations Experience with AMCP dossier and Health Economics and Outcomes Research strongly preferred. Prior launch experience strongly preferred Knowledge and Skills: Proven competence in clinical therapeutics, drug development, business and market knowledge, and strategic resource management. Thorough understanding of the FDA, OIG, ACCME, HIPPA and other ethical guidelines relevant to the pharmaceutical industry. Able to rapidly learn new therapeutic areas in a self-taught and peer-to-peer team learning environment. Excellent communications skill set: interpersonal, networking, verbal, written and presentation. Unquestioned personal integrity coupled with a strong customer focus. Conscientious, enthusiastic team player with excellent collaboration and teamwork abilities. Strong analytical and evaluative skills. Able to organize, prioritize, and work effectively in a constantly changing environment. Computer skills: Ability to interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information. Strong knowledge of MS Office (Word, PowerPoint, Excel). Able to travel 30-60% of the time, or as needed, from home-based office. Willing to attend weekend events (medical conferences, ad boards, speaker training, etc.) on an occasional basis. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Job Description Preferred locations: Cleveland or Detroit Reporting to the Field Medical Director, Medical Affairs, the Medical Science Director performs a vital role within the organization by bridging internal strategy with external medical insights. Through interactions with the healthcare community, the Medical Science Director supports disease awareness activities, participates in scientific exchange, and obtains valuable information regarding unmet medical needs and current treatment paradigms to help guide executive decisions. As part of an emerging US and global organization, the Medical Science Director will also make significant contributions to processes, procedures, and best practices within the developing organization, serve as a medical resource to healthcare providers, clinical investigators and healthcare decision makers regarding the organization's investigational and marketed products, and support product commercialization. Key responsibilities include: Develop enduring professional relationships with healthcare practitioners, clinical investigators, and healthcare decision makers to stay abreast of current scientific and disease management trends. Provide medical and scientific support for Mitsubishi Tanabe Pharma America's (MTPA's) marketed products and areas of therapeutic interest. Gather insights regarding unmet medical needs and treatment landscapes in targeted therapeutic areas. Attend and support scientific and medical meetings. Disseminate clinical and competitive insights within the organization and prepare post-meeting deliverables as needed. Respond to unsolicited requests; provide truthful, non-misleading and non-promotional information regarding MTPA's products to healthcare professionals including physicians, hospital and MCO practitioners and formulary committees, pharmacists, nurse practitioners, physician assistants, dietitians and others. Assist in the development of educational materials and standard responses to frequently asked questions (FAQs); provide product-related site education; serve as medical resource for home office and field colleague training. Present medical and scientific information to healthcare professionals who provide peer education. Support Investigator Sponsored Trials (ISTs) as needed. Ensure that all medical education activities are conducted in full compliance with relevant guidance, rules and regulations. Depending on organizational needs, the Medical Science Director may also be asked to: Support medical initiatives across other therapeutic areas relevant to licensing, translational and clinical development activities. Collaborate with colleagues from Mitsubishi Tanabe Pharma Development America (MTDA) and Mitsubishi Tanabe Pharma Corporation (MTPC, Japan) to support product development activities, including evaluation of target indications and identification of clinical investigators. Qualifications Education: Required: Advanced Degree in Life Sciences: MD, PharmD or PhD. Preferred: MBA Professional Experience: Minimum of 7 years of industry experience (Pharmaceutical, Biotech or related field), including 3+ years of field medical experience, preferably as a Medical Science Liaison (MSL). CNS experience required, preferably in the area of motor neuron disease or neurodegenerative disorders. Experience with customer relationship management required, including thought leader development, speaker bureau training, and formulary presentations Experience with AMCP dossier and Health Economics and Outcomes Research strongly preferred. Prior launch experience strongly preferred Knowledge and Skills: Proven competence in clinical therapeutics, drug development, business and market knowledge, and strategic resource management. Thorough understanding of the FDA, OIG, ACCME, HIPPA and other ethical guidelines relevant to the pharmaceutical industry. Able to rapidly learn new therapeutic areas in a self-taught and peer-to-peer team learning environment. Excellent communications skill set: interpersonal, networking, verbal, written and presentation. Unquestioned personal integrity coupled with a strong customer focus. Conscientious, enthusiastic team player with excellent collaboration and teamwork abilities. Strong analytical and evaluative skills. Able to organize, prioritize, and work effectively in a constantly changing environment. Computer skills: Ability to interface effectively with a variety of technical platforms for the collection, review, and dissemination of medical information. Strong knowledge of MS Office (Word, PowerPoint, Excel). Able to travel 30-60% of the time, or as needed, from home-based office. Willing to attend weekend events (medical conferences, ad boards, speaker training, etc.) on an occasional basis. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **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 $209,599.00 - Maximum $313,375.00, 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.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **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 $209,599.00 - Maximum $313,375.00, 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.

The Medical Director, Rheumatology and/or Dermatology Medical Strategy is a critical role responsible for shaping the strategic processes and planning for assets in early development (e.g., pre-Phase 3) within the Nephrology and Immunology portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Senior Director, Immunology Lead, who in turn reports to the Executive Director, Nephrology & Immunology Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across R&D, Clinical, Global Medical Affairs, and Early Commercialization functions + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the early Nephrology and Immunology portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to early assets **External Stakeholder Engagement** + Identify and engage Medical experts to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Medical Experts + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with Medical Experts to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to early assets **Cross-functional Integration & Planning** + Collaborate within the Nephrology & Immunology Medical Business Unit with the Nephrology & Immunology Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with expertise in **Rheumatology and/or Dermatology** + Preference for previous experience in Clinical Development, Research, or early-stage Medical Affairs + Expertise in Rheumatology or Dermatology is strongly preferred + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + \#LI-PG1 **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 $209,599.00 - Maximum $313,375.00, 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.

The Associate Director, Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and tactical implementation for congresses and medical education, and supporting Otsuka's non-promotional scientific communication initiatives across the diverse Rare Disease portfolio. This role leads scientific engagement through impactful congress planning & execution educational programs, and evidence-based content that support Otsuka's mission to improve patient outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional stakeholders - including Global Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I) and Commercial, to ensure scientific alignment, operational excellence and consistency in Otsuka's external scientific exchange. **** **Key Responsibilities Include:** **Congress Strategy and Execution** + Manage execution and contribute to the development of comprehensive multi-year medical congress strategy for the relevant therapeutic area aligned with Otsuka's pipeline and product lifecycle stages (e.g., establishing and developing an emerging portfolio), including prioritization of key international and regional congresses, scientific communication objectives, symposia, booth presence, and internal/external engagement activities + Collaborate with Medical Strategy, Medical Communications, Field Medical and Medical Information to develop high-quality, scientifically rigorous presentation and materials; ensuring data dissemination plans are timely, consistent, and strategically aligned + Support scientific communication planning across global and regional teams to ensure consistent, data-driven communication objectives across congress activities + Partner with Medical Communications to coordinate Otsuka's scientific presence at congresses, including: + Abstract submissions and poster presentations + Oral presentations and late-breaking sessions + Sponsored symposia and educational sessions + Medical booth design and operations + Press activities and medical engagement + Support planning and execution of engagement with external experts and stakeholders (e.g. KOLs, Patient Advocacy Groups) before during and after congresses + Organize and facilitate investigator meetings and advisory boards in conjunction with congress + Coordinate opportunities for scientific exchange between Otsuka Medical Affairs personnel and external experts and stakeholders + Manage end-to-end aspects of congress planning activities and post-congress insight generation to maximize impact and inform future strategies + Implement innovative digital strategies to extend congress reach and engagement, including virtual and hybrid congress solutions + Establish KPIs for congress activities and implement systems to track and analyze performance + Conduct post-congress analysis toa assess impact and identify areas for improvement **Independent Medical Education (IME)** + Develop and implement the global medical education strategy for relevant therapeutic area in alignment with medical and objectives and strategy + Oversee the development of scientific exchange platforms, independent medical education (IME) initiatives to elevate disease and product knowledge globally + Partner with regional and local teams to ensure educational programs address unmet needs and comply with regional regulations and global standards + Identify, evaluate, and partner with external experts, medical societies and educational providers to ensure high-quality, unbiased scientific content delivery + Monitor educational impact through KPIs, metrics and insights **Cross-Functional Collaboration** + Act as a key contributor and subject matter expert for the relevant therapeutic area medical education and congress activities + Collaborate with Medical Affairs, Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory, and Commercial teams to ensure scientific alignment and appropriate integration of new evidence into educational content + Provide guidance and mentorship to team members and vendors to ensure high standards of scientific integrity, external experts and stakeholder (e.g., KOL) experience and operational excellence + Create and manage congress budgets, ensuring cost-effectiveness and ROI and ensure compliant use of medical education and congress funding + Represent Global Medical Affairs in governance forums and cross-functional planning meetings + Ensure all congress and medical education activities comply with global and local regulatory requirements, Otsuka policies, data publication embargos and industry codes + Proactively identify and mitigate risks related to scientific exchange and external engagements based on Global Medical Affairs policies and SOPs + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) preferred + Extensive experience working within relevant therapeutic area, including engagement with specialized HCPs and evidence generation strategies + Additional business or communications training (MBA, MPH, etc.) preferred + 12+ years of experience in Medical Affairs; ~5 years focused on congress strategy and execution is preferred + Proven success managing matrixed & cross-functional global teams and external vendors + Demonstrated experience leading global congress strategy, IME programs, or scientific engagement + Proven track record of successful congress planning and implementation on a global scale including implementation of digital and virtual congress solutions + In-depth understanding of industry compliance, regulatory frameworks, and ethical considerations for scientific engagement **Skills and Competencies:** + Strategic and analytical thinker with the ability to translate complex science for a variety of audiences and anticipate trends and shape proactive congress and educational strategies + Excellent project management, communication (written and verbal), and stakeholder engagement skills + Collaborative and communicative, with ability excel at building and maintaining relationships with external stakeholders and experts (e.g. KOLs, scientific) + Financial acumen and experience managing large program budget + Ability to influence across matrixed teams and drive strategic initiatives **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 $169,222.00 - Maximum $253,000.00, 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.

The Director, CNS Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the CNS therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the CNS Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, CNS Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for CNS assets, ensuring strategic alignment with global medical and communication objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels + Future potential to manage other direct reports or a team **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows, including considering managing in-house development of some publication content **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the CNS Medical Communications function, providing strategic and operational guidance and support to internal stakeholders and vendors + Partner with Field Medical and Medical Core content leads to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in CNS or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives + Proven experience leading a team a plus **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 $186,489.00 - Maximum $278,875.00, 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.

**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each day. **About the Role** The Omnichannel Center of Excellence is dedicated to driving innovation, building, and delivering capabilities that enhance Otsuka's opportunity to make an impact in the lives of those we serve. We achieve this through our relentless focus on customer centricity, patient empathy, expertise in enabling pathways for disease education and awareness of management options, and our unwavering commitment to supporting access to treatment. We are looking for an **Omnichannel Data Scientist** , **Medical Omnichannel** with strong expertise in artificial intelligence, encompassing machine learning, data mining, and information retrieval. This position specifically entails the conceptualization, prototyping and development of next generation advanced analytics model-based decision engines and services. The ideal candidate will engage closely with key stakeholders to understand strategic objectives and leverage advanced data analytics and machine learning techniques to enhance communication strategies, ensuring seamless and personalized interactions with healthcare professionals (HCPs) and key opinion leaders (KOLs). **Job Expectations/Responsibilities:** **Data Integration & Management** + Explore and analyze common pharmaceuticals data (e.g., claims) as well as novel data sets based on lab and EHR systems. Work with Omnichannel Data Engineer to Integrate data from multiple sources (e.g., CRM systems, social media, email platforms) to create a unified view of stakeholder interactions. + Apply natural language processing (NLP) to extract insights from unstructured medical texts, such as clinical notes or call center transcripts. + Identifying relevant data drivers (features) that can inform decision making closely tied with strategy and creating visualizations to help communicate findings. **Advanced Analytics & Modeling** + Implement advanced analytics models, including predictive analytics and clustering algorithms, to generate actionable insights and track trends across various channels. + Work with Omnichannel ML/Ops engineer to build, test, and deploy production-grade predictive models and algorithms as part of the Omnichannel COE decision engine to meet business needs, including optimization of sales activities and predicting drivers of customer behavior. + Create repeatable, interpretable, dynamic, and scalable models that are seamlessly incorporated into analytic data products and match the needs of Otsuka's growing portfolio. + Collaborate on MLOPS life cycle experience with MLOPS workflows traceability and versioning of datasets. Build and maintain familiarity with Otsuka Machine Learning tech stack including AWS, Kubernetes, Snowflake, and Dataiku **Omnichannel Optimization** + Design and deploy recommendation systems to tailor communications based on stakeholder preferences and behaviors. Utilize machine learning algorithms (e.g., collaborative filtering, content-based filtering) to enhance personalization efforts. + Analyze the performance of omnichannel campaigns (email, SMS, in-app, HCP portals, etc.) to identify high-impact touchpoints and optimize engagement strategies. Use A/B testing and uplift modeling to evaluate the effectiveness of different communication strategies and content types. **Stakeholder Collaboration** + Effectively communicating analytical approach to address strategic objectives to business partners. + Work closely with medical affairs, marketing, and IT teams to ensure alignment and integration of omnichannel strategies. Provide technical guidance and support to cross-functional teams on data-related projects. + Stay updated with emerging industrial trends (Conferences and community engagement) and develop strategic industry partnerships on Omnichannel analytics to strengthen Otsuka's analytical methods and outcomes. + Model Otsuka's core competencies (Accountability for Results, Strategic Thinking & Problem Solving, Patient & Customer Centricity, Impact Communications, Respectful Collaboration & Empowered Development) that define how we work together at Otsuka. Key matrixed partners included: Brand Marketing, Creative / CRM / Digital agencies, Media, Market Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/Regulatory/Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree in data sciences, computer science and 4-6 years of relevant experience **Preferred Knowledge, Skills, and Abilities:** + Demonstrated experience with scripting and implementing data analytics algorithms and models. Hands on experience using a modeling and simulation software (e.g. Python, Matlab, R, NONMEM, SAS, S-Plus, etc.) is a plus. + Knowledge/Experience in the usage of machine learning/AI tools in life science area(s) and handling life science datasets is preferred. + Excellent interpersonal, technical, and communication skills to lead cross-functional teams. + Profound grasp of Machine Learning lifecycle - feature engineering, training, validation, scaling, deployment, scoring, monitoring, and feedback loop. + Have implemented machine learning projects from initiation through completion with particular focus on automated deployment and ensuring optimized performance. + Agile skills and experience + Experience in Healthcare (esp. US) industry is a plus. **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 $164,530.00 - Maximum $245,985.00, 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.

Medpace is the leading CRO for Biotech companies and is continuing to add senior-level Directors and established Project Managers to join our Clinical Trial Management Group in Cincinnati, OH. Therapeutic area of focus is Oncology, Hematology, and more. We offer a very competitive salary/bonus program, plus equity grants which have become very lucrative for our associates. Responsibilities * Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations * Serve as primary Sponsor contact for operational project-specific issues and study deliverables * Maintain in depth knowledge of protocol, therapeutic area, and indication * Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided * Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable * Develop operational project plans * Manage risk assessment and execution * Manage study vendors where applicable * Manage site quality and monitoring deliverables Qualifications * Bachelor's degree in a health-related field; Advanced degree in a health-related field preferred * Experience in Phases 1-4; Phases 2-3 preferred * 5+ years as a project/clinical trial manager within a CRO * Management of overall project timeline * Bid defense experience * Strong leadership skills Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Job Address: 1223 Market Avenue North Canton, OH 44714 New Vista is currently recruiting a Social Worker for the leadership role of Director of Clinical Services at Sunrise Vista, a Behavioral Health Hospital located in Canton, OH. Credentials: MSW, LSW, or LISW required. THE ROLE The Director of Clinical Services is responsible for the oversight of all clinical treatment programs of patients receiving psychiatric treatment at the behavioral health hospital. The Director assures that high quality clinical care is provided and that clinical functions are integrated. The Director supervises individual and group counseling and develops and implements a variety of therapeutic treatment modalities/processes. The Director oversees discharge planning to ensure an optimal post hospital transition. The Director is also responsible to ensure that clinical documentation is current and accurate and meets all regulatory and other standards. WHO WE ARE The New Vista mission: Inspiring Hope, Restoring Peace of Mind, Healing Lives. At New Vista, our passionate and highly trained team of professionals inspires hope and delivers holistic care to those in need of behavioral health services in a contemporary and healing environment - one that is conducive to providing the life skills needed to regain stability and independence. With a blend of group therapy, clinical treatment, and unique surroundings, our beautiful healthcare centers provide a safe, serene, healing environment for adults and seniors with a variety of complex needs. New Vista's Ethan Crossing Addiction Treatment Centers work with individuals and their support systems to identify factors leading to addiction, equip individuals with the resources needed to address addictive triggers, and reconnect individuals with their support system and community. From scheduling an admission date to acquainting individuals with the campus and everything in between, patients are supported by our team of compassionate employees. Our compassionate team members work in a challenging yet rewarding environment where each person is a part of making direct impact on our patient's lives. PERKS AT WORK Team Members enjoy a variety of perks in working with the NewVista brand company. We offer competitive market wages along with a full, robust package: Healthcare + Life Balance Medical Packages with Rx - 3 Choices Flexible Spending Accounts (FSA) Dependent Day Care Spending Accounts Health Spending Accounts (HSA) with a company match Dental Care Program - 2 choices Vision Plan Life Insurance Options Accidental Insurances Paid Time Off + Paid Holidays Employee Assistance Programs 401k with a Company Match Education + Leadership Development Up to $15,000 in Tuition Reimbursements OR Student Loan forgiveness Mentoring + Trainer Opportunities through our Horizon Mentorship Program Growth in Director and CEO positions through our Horizon Leadership Program Handle with Care Trainer - Certifications Recognition + Rewards On the spot recognition Prizes Team Member of the Quarter Team Member of the Year Monthly Celebrations Team Member Recognition Cards JOB REQUIREMENTS To qualify for the Director of Clinical Services position, you must have: MSW, LSW, LISW, LPC, or LPCC required. A Master's degree from an accredited school for Social Work, Counseling, Marriage and Family Therapy, or Chemical Dependency and qualified by education and experience in the social services needs of patients with psychiatric and substance abuse issues. 3 or more years of experience in inpatient healthcare with knowledge of psychiatric and chemical dependency treatment principles The successful candidate must acquire CPR certification and Crisis Prevention Training (CPI) within 30 days of employment and prior to any patient contact and may be required to work flexible hours. JOB RESPONSIBILITIES As Director of Clinical Services, you will: Ensure that hospital approved programs are implemented and provided consistently. Provide oversight to the therapists and provide feedback through the performance evaluation process and, if necessary, through counseling. Ensure that all interventions (individual, group, and family therapy) are performed and documented according to professional clinical standards. Actively participate in survey activities (TJC, Medicare, and licensing). Coordinate performance improvement and complete monthly reporting. Attend treatment team meetings on a regular basis. Ensure that clarification of the therapeutic role and treatment plan with the patient and family is completed. Actively participate in the complaint resolution process as needed. Collaborate with leadership team members on all matters related to hospital operations. Qualified candidates, please apply now for a chance to join our outstanding team as we Inspire Hope, Restore Peace of Mind, and Heal Lives .