Senior Director jobs at Astellas Pharma - 48 jobs

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose & Scope: We are seeking an experienced leader to serve as the Identity & Security Engineering Lead. This role will be responsible for defining strategy, leading teams, and ensuring operational excellence across our Microsoft identity management platforms while also overseeing broader security engineering domains including cloud security, OT security, application security, and infrastructure security. A critical focus area will be advancing our Multi-Factor Authentication (MFA), Conditional Access, and Privileged Access Management (PAM) capabilities to enable secure, seamless user experiences. Beyond identity, this leader will drive security engineering excellence across cloud, OT, and enterprise platforms. This role will be accountable for global delivery through a hybrid workforce model, managing both internal engineering teams and external service providers/partners across multiple regions and time zones. Operating within an agile delivery model, the Identity & Security Engineering Lead will ensure identity and security engineering capabilities are delivered with speed, adaptability, and business alignment. The role may be based in the United States, Canada, United Kingdom, Poland, Mexico, India, or Japan, with global responsibilities across all regions. Responsibilities and Accountabilities: Strategic Leadership · Define and execute the enterprise vision for Microsoft Identity platforms (Active Directory, Azure AD / Entra ID, M365 Identity Services, MFA, Conditional Access, PAM). · Lead strategy and delivery across broader security engineering domains including cloud security, OT security, and infrastructure/application security. · Drive a global MFA-first strategy, embedding Zero Trust principles across the enterprise. · Ensure identity and security engineering programs support digital transformation, cloud adoption, and regulatory compliance. Operational Excellence · Ensure global reliability and performance of MFA and Conditional Access policies. · Automate identity lifecycle management (provisioning, de-provisioning, access reviews, PAM). · Deliver security engineering solutions for cloud platforms (Azure, AWS, GCP) and OT/critical infrastructure environments. · Apply agile delivery methodologies to accelerate delivery, manage backlogs, and adapt quickly to evolving requirements. · Manage service delivery performance across both internal teams and external vendor partners. · Risk, Compliance & Governance · Partner with GRC to ensure identity and security engineering controls meet NIST CSF, ISO 27001, SOX, HIPAA, EU AI Act, and other regulatory frameworks. · Lead audit and compliance programs across identity, cloud, and OT security domains. · Anticipate and mitigate emerging risks by adapting MFA and security engineering strategies. Collaboration & Influence · Serve as a trusted partner across infrastructure, applications, OT, business stakeholders, and senior executives. · Position MFA, identity, and security engineering as key enablers of business productivity and compliance. · Represent the function in enterprise-wide programs including global network refresh, cloud adoption, OT modernization, and M&A integrations. · People & Talent Leadership · Lead and mentor a global team of internal and external resources, ensuring alignment and accountability across multiple regions and time zones. · Foster agile, cross-functional teams that collaborate across infrastructure, applications, and business domains. · Manage vendor partnerships and enforce accountability for quality, SLAs, and innovation. · Develop succession plans, training paths, and career opportunities in Microsoft identity, MFA, and advanced security engineering. · Promote a culture of inclusion, agility, innovation, and continuous improvement.

#LI-Remote The Associate Director, Access & Reimbursement, Oncology - South Florida/PR is a remote & field-based role that covers the following, but not limited to: Miami, Fort Lauderdale and Fort Myers, FL. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border. Job Description The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care. ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects. ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates). Key Responsibilities: Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows. Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices. Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products. Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments. Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay). Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed). Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education. Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement. Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines). Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes. Buy and Bill Specific: Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel. Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration. Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement. Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams. Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc. Essential Requirements: Education: Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred. 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s). Experience working with highly complex practices and/or health systems to establish access and acquisition pathways. Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access. Deep expertise and experience integrating manufacturer-sponsored patient support programs. Experience with specialty products acquired through Specialty Pharmacy networks Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail) Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region. Must live within assigned territory. Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up. Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. Desirable Requirements: Experience leading and delivering presentations to C-level account executives. Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates. Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs. Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills. This position requires significant use of a company provided vehicle and maintaining good driving record This is a field-based customer engaging position Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager. Novartis Compensation Summary: The salary for this position is expected to range between $160,300 and $297,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions, Waterfall ModelRequiredPreferredJob Industries Other

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Are you passionate about applying your pharmacometric skills, strategic thinking, and practical experience in data analysis? Would you like to join cross-functional clinical development teams, and do you feel like expanding your influence and deepening your knowledge in pharmacometric approaches? The Senior Associate Director/ Director - Pharmacometrics will independently perform high quality pharmacometric (PMx) analyses on a project and study level essential for internal decision making and successful approval. The incumbent will represent Clinical Pharmacology/PMx in project and trial teams as well as author PMx documents and develop PMx strategy. Duties & Responsibilities Develops PMx strategy and contribute to the clinical development plan and implement model-informed drug discovery and development (MID3) in clinical development projects with limited support of supervisor Ensures timely delivery of state-of-the-art PMx analyses for internal decision making throughout clinical drug development and registration (e.g., non-linear mixed effects models, model-based meta-analyses for dose selection, labeling, optimizing clinical study designs and pediatric development) Ensures timely delivery of PMx internal documents (e.g., dataset specification, PMx analysis plan, and PMx report) Ensures timely delivery of documents where PMx is co-author (e.g., clinical development plan, pediatric investigational plan, submission documents) Represents TMCP Clinical Pharmacology/PMx in clinical development teams, initiatives and working groups (both internal and external) such as focus groups in your therapeutic area of expertise, across department initiatives, process harmonization, IMI calls, ISoP groups, Open Systems Pharmacology. Organizes and manages projects with external organizations (e.g., academic institutions or CROs) Understands current national and international regulations, local requirements, BI policies, and procedures as relevant to areas of expertise Applies this knowledge to ensure safe and compliant practices, manage risks, and maximize opportunities for projects to succeed Assumes responsibility for direct reports as needed including recruiting and managing; Mentors and develops scientific staff; Directs and oversees analyses and results of junior level scientists Additional tasks for the Director role: The Director Pharmacometrics is expected to perform the responsibilities listed for the Sr. AD level fully independently. Continuously evaluate and implement novel pharmacometric approaches and may support or drive the development of quantitative methodological approaches, pharmacometrics (software) tools, and related business processes. Requirements Master's Degree in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with a minimum of six (6) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia. OR PhD in Medicine, Pharmacometrics, Clinical Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or equivalent area of focus with minimum of four (4) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia OR Professional degree in pharmacy or medicine (e.g., PharmD, MD, Apotheker, Arzt) with a minimum of five (5) years relevant experience in Pharmacometrics in the pharmaceutical industry, regulatory agencies, or academia. Two to four (2-4) years relevant experience in working in clinical development teams, preferred. Proficiency in applying PMx software (e.g., NONMEM, Monolix, R, SAS, PBPK software) Proficient knowledge in clinical pharmacology, clinical drug development, MID3, and regulatory guidelines Strong team player, who is able to successfully act in the global context Good interpersonal skills with the ability to interact effectively with people, internally and externally Additional requirements for the Director role: Seven (7) + years relevant experience in Pharmacometrics in the pharmaceutical industry, CROs, regulatory agencies, or academia Five (5) + years of relevant experience in working in clinical development teams (preferred) Broad knowledge in applying PMx software and approaches Broad knowledge in other data science fields, clinical pharmacology, clinical drug development, MID3, and regulatory guidelines Compensation: This position, Sr. AD, Pharmacometrics, offers a base salary typically between $170,000.00 and $269,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Eligibility Requirements Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

**Company Background/Culture** Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas. **Culture** As a Company with a rich 100-year history, Otsuka is proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed. Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility. **Pipeline** Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product's full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products. You can learn more about Otsuka by clicking here! (******************************************* **** **Position Summary** Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific leadership to cross-functional study teams and ensure high-quality clinical trial design, conduct, and data interpretation. + Serve as the medical lead and subject matter expert for assigned indications. + Partner with cross-functional team to ensure trials are conducted in compliance with GCP, regulatory requirements, and internal processes. + Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees. + Lead clinical discussions with KOLs and advisory boards. + Develop clinical documents including medical monitoring plans, asset development plans + Contribute to development of publication plans and review scientific manuscripts for publications. + Mentor and provide leadership to junior team members within the organization. + Support business development activities through medical due diligence and evaluation of external opportunities. + Contributes to corporate initiatives by participating in continuous process improvement to meet company **Knowledge, Skills, Competencies, Education, and Experience** Required: + A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician. + Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia). + Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). + An advanced understanding of clinical medicine and science. + Advanced understanding of drug development principles and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and commercialization. + Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting. + Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies, + Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus. + Ability to work across different therapeutic areas and different stages of clinical development. + Demonstrated ability to manage and motivate clinical team members (e.g., internal staff and external investigators/consultants). + Strong communication and presentation skills. + Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). + Knows how/when to apply organizational policy or procedures to a variety of situations. + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed, including: + Flexibility in working across different therapeutic areas and experience in different stages of clinical development. + Working knowledge of associated disciplines, including immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing. + Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage. **Physical Demands and Work Environment** + Travel (~30-35%) + See document Physical Demands and Work Environment for further requirements. **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Director, Medical Communications, CNS directs and provides strategic leadership for the global and US scientific communication strategy for the assigned Central Nervous System (CNS) therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position within the CNS Business Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the CNS portfolio aligned to the overall medical strategy + Collaborate with the CNS Medical BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all CNS medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for CNS assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver high quality publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific messaging and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Medical Information Content Generation:** + Oversee the creation, review, and approval of high-quality medical information content, including standard response letters, FAQs, global core content, and scientific response documents. + Ensure all content is scientifically accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to ensure consistency and alignment of messaging across channels. + Drive the development and implementation of content governance frameworks, version control processes, and global-to-local adaptation strategies. + Manage external vendors and medical writing agencies to ensure timely and high-quality content delivery. + Provide leadership and mentorship to a team of medical writers, content strategists, and reviewers, fostering a culture of excellence and continuous improvement. + Monitor and analyze content performance and stakeholder feedback to inform future content strategy and optimization. + Consider technology and AI to support workflow improvement **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core CNS team meetings, aligning communication plans with CNS BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the US Field Medical Affairs Lead to ensure the field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in Neuroscience or a related CNS field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global and/or US communication strategies for a marketed or late-stage development product, preferably in CNS therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus. **Skills and Competencies:** + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $230,720.00 - Maximum $345,000.00, 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.

**_Sr. Director, Brand Lead, Neuroscience_** The Senior Director, Brand Lead, Neuroscience is responsible for leading the commercial strategy, brand positioning, launch readiness planning, and execution within a therapeutic category (schizophrenia and other psychiatric disorders), ensuring a successful launch and sustained market growth. This role will drive the development of HCP and consumer marketing strategies, optimizing engagement and adoption through omnichannel execution, market development, and field force enablement. In addition, this role will help steer the global Lifecycle Management plan across multiple potential psychiatric disorders. Responsible for development the commercial go-to market model and overall cross-functional launch plan. The Senior Director will lead a cross-functional team, working closely with market access, sales, medical affairs, regulatory, and commercial excellence to align on strategic priorities and ensure a competitive market presence. The candidate will have financial responsibility for the product P&L. This role requires a highly strategic and execution-focused leader with deep brand and launch experience in the psychiatric and/or neuroscience space (CNS). **Key Responsibilities** + **Launch & Brand Strategy Development:** Lead commercial launch strategy, ensuring successful brand positioning, HCP engagement, and market activation. Ensure alignment of all cross-functional plans to overall brand strategy + **HCP Marketing Leadership:** Develop and oversee HCP engagement strategies, including non-personal promotion (NPP), speaker programs, congresses, and KOL partnerships. + **Consumer Marketing:** Drive consumer engagement initiatives, ensuring effective education and activation efforts that align with market needs and patient journeys. + **Omnichannel & Digital Strategy:** Lead omnichannel marketing efforts and personalized engagement content, integrating digital, personal, and non-personal promotional approaches to maximize reach and engagement. + **Market Insights & Competitive Analysis:** Utilize market research, analytics, and competitive intelligence to refine marketing strategies and anticipate market shifts. + **Sales Enablement:** Develop messaging, promotional materials, segmentation, and field guidance to support the salesforce in driving HCP engagement and adoption. Guide development of training and meetings to align with brand strategy. + **Market Access:** Partner with market access teams to ensure payer engagement, reimbursement strategy alignment, channel strategy, development of affordability and access programs, patient support solutions, and pull-through execution. + **Cross-Functional Leadership:** Collaborate closely with medical, regulatory, commercial operations, and finance teams to ensure cohesive brand execution. + **Performance Measurement & Optimization:** Define and track key performance indicators (KPIs) to assess brand performance and optimize investments + **Financial Management:** Oversee development of net sales and demand forecasts along with overall launch P&L to optimize profitability + **Budget & Resource Management:** Oversee marketing budgets and resource allocation, ensuring efficiency and ROI optimization. + **Team Leadership & Development:** Lead a team of HCP and consumer franchise brand marketers, providing guidance, mentorship, and strategic direction to drive high performance and execution excellence. **Qualifications & Key Competencies** + Bachelor's degree in business, Marketing, or a related field; MBA preferred + 10+ years of pharmaceutical marketing experience, with a focus on CNS, Psychiatry, or related therapeutic areas + Proven experience leading a pharmaceutical product launch, preferably in CNS, including experience working with a product across multiple indications + Experience in both HCP and consumer marketing, with the ability to develop integrated brand strategies + Experience in market access, sales, and/or commercial operations highly preferred + Omnichannel expertise, including digital engagement, NPP, field force integration + Strong cross-functional collaboration skills, with experience partnering across market access, medical affairs, and sales teams + Financial acumen, with experience managing P&L, budgeting, and ROI analysis + Excellent leadership and team development skills, with a track record of building and managing high-performing teams + Strong analytical and strategic thinking skills, with the ability to leverage data and insights to refine execution + Experience working in a matrixed environment, managing multiple priorities and aligning teams to achieve commercial success **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Senior Director, Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific communication strategy for the assigned Nephrology & Immunology therapeutic area and product portfolio. This includes directing the development and dissemination of all core scientific and medical content (e.g., global slide decks, congress abstracts/presentations, publications, medical information, and medical education materials) to ensure scientific accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology & Immunology Unit (BU) Medical Affairs team, influencing and engaging internal stakeholders, external experts, and the broader scientific community. The role reports directly into the Executive Director, Nephrology & Immunology Business Unit Lead. **** **Key Responsibilities:** **Global Scientific Communication Strategy** + Define, direct, and oversee a comprehensive medical communications strategy and tactical plan for the Nephrology & Immunology portfolio aligned to the overall medical strategy (developed by the medical strategy team) + Collaborate with the Nephrology & Immunology BU Lead and cross-functional teams (e.g., Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial) to ensure global and US alignment + Shape the scientific narrative for the therapeutic area, ensuring consistency across publications, congresses, and external engagements + Drive innovation in how scientific data is communicated, including digital transformation and real-time engagement models **Content Development Oversight** + Provide executive oversight for and ensure the strategic alignment of all Nephrology & Immunology medical affairs communication materials, including but not limited to + Scientific Communications Platform (SCP) + Global Publications Strategy + Global Medical Publications Plan + Core Disease State Deck + Core Field Materials + Medical Publications + Integrated Medical Communications Planning + New Data Reporting + Medical Information Content Generation **Publications Strategy** + Direct strategic vision and ensure execution of the global publication plan for Nephrology & Immunology assets, ensuring successful presentation of clinical data at major international congresses and in peer-reviewed journals + Direct agency and vendor relationships to deliver publication deliverables **Congress Planning** + Set strategic priorities for congress participation and direct the planning and execution of Medical Affairs activities at major scientific congresses (e.g., booth content, symposia, internal debriefs) + Ensure coordinated scientific communication objectives and cross-functional alignment in close collaboration with Medical Excellence & Operations (ME&O) roles **Cross-Functional Leadership** + Act as a thought leader and senior advisor on core Nephrology & Immunology team meetings, aligning communication plans with Nephrology & Immunology BU Medical Strategy and influencing enterprise-wide decisions + Partner closely with the Global Field Medical Affairs Lead to ensure the global field medical team is equipped with scientifically accurate, consistent, and compliant content aligned to US strategy + Support launch readiness for new indications or pipeline assets, including data dissemination and stakeholder education + Ensure all communication activities adhere to relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory/legal requirements, establishing governance frameworks to ensure compliance across the function + Consider technology and AI to support workflow improvement + Manage and mentor a team of medical writers and communication professionals, fostering excellence, innovation, and continuous development. **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with a strong understanding of clinical development and medical science, preferably in a Nephrology & Immunology related field + Minimum of 10 years of experience in Medical Affairs, Medical Communications, or Publication Planning within the pharmaceutical or biotechnology industry + Minimum of 5 years of progressive experience directing, developing, and providing executive leadership to a team of direct reports within a global communications function + Demonstrated track record of defining and directing enterprise-level global communication strategies for late-stage assets and an emerging portfolio, preferably in Nephrology & Immunology therapeutic areas + Proven experience in managing complex budgets, directing large-scale initiatives, shaping workforce planning, and managing agency and vendor relationships on a global scale + Previous experience overseeing or leading medical information groups is a plus **Skills and Competencies:** + Strong ability to present to executive leadership team + Strong leadership and delegation skills, ability to manage performance, and foster a culture of scientific excellence and accountability at the departmental and cross-functional level + Superior skills in translating long-term business and clinical goals into actionable, measurable, and integrated medical communication strategies that influence enterprise-level decision-making + Demonstrated ability to manage multiple complex projects simultaneously, set clear priorities, and direct organizational processes to ensure operational excellence across varied functional responsibilities (publications, content, congress) + Excellent written and verbal communication skills, with the ability to influence and align senior leadership on complex scientific and strategic priorities while engaging cross-functional partners + Knowledge of digital platforms and tools for medical content delivery and engagement **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $225,490.00 - Maximum $337,180.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The Global Integrated Evidence Operations, Associate Director role oversees and coordinates the operational processes, digital system support, and governance for Global Integrated Evidence & Innovation (GIE&I), which includes responsibility for operating models, system readiness, and process adherence for integrated evidence planning (IEP) and generation programs across the enterprise. In addition, the role will play a crucial role in enhancing the efficiency and effectiveness of general department operations to support timely and transparent delivery of high impact evidence. Responsibilities: + Support the creation and management of IEPprogramwith a focus on operational efficiency by building out andmaintainingdigital planning platform/repository + Track and report IEP programupdatesto leadership + Overseethe digital IEPplanning platform/repository andmonitordata quality + Ensure operational excellence through the continued development and implementation of standardized processes, tools, and governance for IEPand generation + Contribute to the development of operational KPIs and dashboards tomonitorperformance and drive continuous improvement for IEPplanning and generation + Lead enterprise training,change management, and capability building forsystems, process, and governance + Supportevidence planning governance to ensure alignment with asset vision and strategic objectives + Supportevidence generation governance to oversee the execution of evidence generation activities. + Contribute strategic thinking and thought partnership forevidenceoperations,systemsand governance + Recommend process improvements and efficiencies toleadership + Develop andmaintainrelationships with colleagues involved in the IEP, evidencegenerationand governance processes. **Requirements:** + Bachelor's degree in drug development or business management. + 5+ years of experience in life sciences or project management supporting research needs. + Proventrack recordin program management with matrixed teams in health or life sciences. + Strategic mindset with the ability to prioritize tasks andfocuswork accordingly. + Capability to synthesizelarge amountsof data into meaningful content. + Strong written, verbal, and presentation skills for diverse stakeholders. + Excellent project, time management, and organizational skills. + Ability to thrive under pressure, meet deadlines, and lead parallel projects. + Competence in drug development lifecycle and scientific understanding of assets. **Preferred:** + Formal training or certification in project management methodologies (PMP, Six Sigma, Agile). + Experience in developing IEPs or managing complex processes across cross-functional stakeholders. + Experience in leading or working closely with leadership governance + Successful execution and management of multiple projects supporting life sciences research. + Technical experience in drugdevelopment/commercialization. + Knowledge of drug development lifecycle functions such as Discovery, Clinical Trials, and Regulatory. + Experience with digital technology to support management of planning and research **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.

The Associate Director, Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and optimize global quality system processes across a global quality organization. This role is instrumental in ensuring that quality operations are efficient, compliant, and aligned with strategic business goals. **** **Operational Excellence** + Lead continuous improvement initiatives across global quality to enhance efficiency, effectiveness, and compliance. + Identify and implement best practices, metrics, and tools to drive performance and accountability. + Facilitate cross-functional collaboration to streamline and optimize end-to-end workflows, as well as enhance overall operational alignment. + Ensure effective change management strategies are applied to drive successful implementation and adoption of operational initiatives. **Risk Management** + Develop and maintain a proactive quality risk management framework aligned with ICH Q9 principles. + Conduct risk assessments for quality processes, systems, and operations, and support mitigation planning. + Monitor and report on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the design, implementation, and maintenance of global quality system processes (e.g., deviation management, CAPA, change control, document management) guided by process excellence principles. + Ensure harmonization and standardization of quality processes across sites and regions. + Support quality system enhancements and digital transformation initiatives, ensuring they are informed by robust business process design and governance practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (e.g., FDA, EMA, PMDA) and internal standards. + Support internal audits and regulatory inspections, including readiness activities and remediation. + Analyze, monitor, and maintain KPIs and dashboards to identify trends, root causes, and opportunities for continuous improvement. **Leadership & Collaboration** + Serve as a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs, IT, and other functions to ensure integrated quality operations. + Align process improvement initiatives with strategic goals and support leadership in prioritizing efforts that deliver the greatest organizational impact. + Represent Quality Operations in global forums and strategic planning initiatives. **Qualifications** Required + Bachelor's degree in life sciences, engineering, or related field; advanced degree preferred. + 8+ years of experience in pharmaceutical quality operations, with exposure to both small molecule and biologics. + Strong knowledge of GxP regulations, quality systems, and risk management principles. + Proven experience in operational excellence and process improvement methodologies (e.g., Lean, Six Sigma). + Excellent communication, leadership, and project management skills. + Ability to work in a global, matrixed environment and manage multiple priorities. Preferred + Experience with global quality systems platforms (e.g., Veeva, TrackWise). + Familiarity with digital transformation and data analytics in quality operations. + Prior involvement in regulatory inspections and audit readiness. **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 $146,955.00 - Maximum $219,650.00, 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, External Expert Strategy & Engagement is a critical role responsible for defining, standardizing, and overseeing the company's global strategy for engaging a broad spectrum of external stakeholders. This includes Key Opinion Leaders (KOLs), Digital Opinion Leaders (DOLs), Payers/Access Stakeholders, Academic/Integrated Health Systems, Patients/Caregivers, and Patient Advocacy Groups. The role is accountable for establishing the governance, process clarity, and technological infrastructure necessary to ensure coordinated, high-value, and non-transactional interactions across all functional areas, distinguishing tactics based on the asset lifecycle stage (Early vs. In-line). This position reports directly to the Executive Director of External Engagement and Field Excellence. **** **Key Responsibilities:** **Strategic Governance and Accountability** + Establish clear accountability and process ownership for all external expert engagement activities, defining roles and responsibilities across the Medical Affairs (GMA) function to address the current pain point of limited clarity on accountabilities and responsibilities. + Develop and implement a standardized global strategy for external engagement that distinctly tailors objectives based on asset lifecycle (e.g., Early Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical/economic value). **System and Data Management** + Coordinate with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management, Corporate Communications, and Government Affairs) and IT to migrate multiple, overlapping stakeholder lists. + Drive process adherence for the consistent upkeep and governance of the centralized external stakeholder list, ensuring the database accurately tracks engagement across all categories of stakeholders (e.g., Patients/Caregivers, Academic Systems, Digital Opinion Leaders). + Champion the use of the centralized system to track all medical expert interactions, contact attempts, and strategic insights captured. **Coordination and Best Practices** + Facilitate connections between the designated primary stakeholder lead contact and any internal team member seeking subsequent outreach to prevent multiple concurrent communications and requests. + Encourage and mandate best practices for GMA preparation before any stakeholder outreach, ensuring all engagement is high-quality and strategically aligned. + Partner with the Training team to develop standardized training and resources for internal teams on proper engagement protocols, compliance guidelines, and use of the centralized Veeva system, highlighting the specific goals for engaging each stakeholder group. + Collaborate with Global Training Lead to coordinate any needed training on external engagement processes and/or capabilities. + Consider technology and AI to support workflow improvement. **Qualifications:** **Education and Experience:** + Advanced scientific or clinical degree is required (PharmD, MD, PhD, or equivalent). + Minimum of 8 - 10 years of progressive experience in the pharmaceutical or biotechnology industry, with at least 5 years in Global Medical Affairs, Strategic Operations, or an equivalent function focused on External Expert/KOL Engagement. + Proven experience in designing, implementing, and managing global engagement processes across multiple therapeutic areas and across different asset lifecycle stages. + Demonstrated success in leading a complex cross-functional project (e.g., system migration, process standardization) involving IT and multiple business units. **Skills and Competencies:** + Exceptional ability to drive process governance and change management across a global matrix organization. + Superior Stakeholder Management and influencing skills, capable of gaining consensus and driving compliance among diverse functional leaders (Commercial, Clinical, Global Medical Affairs). + Strong technological acumen with proven experience working with Veeva or similar management platforms for centralized data management. + Excellent communication and presentation skills, with the ability to articulate the strategic value of coordinated external engagement to senior executive leadership. + Motivated and solution-oriented, with a clear focus on simplifying complex processes for end-users. **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 $183,335.00 - Maximum $274,160.00, 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.

As a senior leader within Medical Affairs, the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical Affairs, providing high-level guidance and operational leadership across the organization. Leveraging a deep understanding of industry trends and internal priorities, this individual will shape the development of best-in-class medical excellence capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director, Medical Affairs Strategy, Excellence & Operations will lead five critical teams: Strategic Planning, Business Solutions & Analytics, Vendor & Contracts Management, Governance & Procedures, and Global Medical Evidence Operations ensuring alignment with enterprise goals and medical excellence priorities. This role will champion operational rigor, foster strategic integration, and drive high-quality insights to support decision-making across the organization. Serving as a key liaison across the Global, US, and Commercial ecosystem, the Executive Director will play a pivotal role in advancing scientific and medical initiatives. Through thoughtful leadership and collaboration, this individual will shape and execute the global medical affairs strategy, optimize operational frameworks, and enable data-driven innovation across therapeutic areas. **** **Key Responsibilities Include:** **Strategic Leadership and Execution** + Serve as Chief of Staff to the VP of Medical Affairs, driving strategic alignment and operational integration across the Global Medical Affairs organization. + Sets the overall direction of Medical Excellence & Operations (MEO); make critical decisions that have impact across Global Medical Affairs therapeutic areas (TAs) and functions + Leads the development, refinement, and execution of Medical Affairs strategies and objectives in alignment with corporate goals. + Coordinates cross-functional planning, meeting cadences, budget oversight, and communication on behalf of Medical Affairs leadership. + Collaborates with cross-functional teams to align medical affairs activities with commercial and clinical development strategies + Leads Medical Excellence for Med Affairs Strategy to ensure consistent best practices across programs and drive consistent methods of strategic and tactical planning and execution. **Operational Excellence and Team Management** + Lead and manage core operational pillars within Medical Affairs Excellence & Operations Team, including: + Global Asset Strategic Planning + Business Solutions and Analytics + Vendor and Contracts management + Global Medical Evidence Operations + Governance and Procedures + Establish and implement systems, SOPs, and governance frameworks to ensure excellence, compliance, and efficiency in Medical Affairs processes (e.g., IME, ISTs, EAPs, publications, congresses) + Provide and maintain the technological infrastructure, business tools, and data analytics, including the medical information contact center, to enable Global Medical Affairs teams to operate efficiently + Oversee the department's budget, resource allocation, and vendor contracting processes (including key TA level vendors) + Will ensure assignment of Med Excellence activities/projects to Otsuka priorities + Congress Strategy/prioritization, ensure aggregation of congress plans (including meetings) and awareness cross functionally + Develop and maintain calendar of important TA meetings across programs, including congresses and internal offsite meetings (US and Global) to ensure no conflicts and adequate resourcing; will work with Administrative leads to ensure meetings are added to calendars + Develops and manages large teams driving a high-performance culture; understands the required skillset (s) needed within the medical excellence function to deliver best results + Builds relationships with key internal and external stakeholders, including industry partners **Performance Monitoring and Reporting** + Establish and track key performance indicators (KPIs) to measure Medical Affairs impact and execution + Deliver monthly and quarterly updates to Global Medical Affairs leadership and contribute to board-level reporting, as needed + Keeps abreast external environment-relevant trends and incorporates insights and best practices to inform functional decisions + Responsible for ensuring timelines and process for cross-brand initiatives, such as annual medical strategy planning, 3-year roadmaps, SMART goals **Qualifications** **Education and Experience:** + Doctorate Degree (MD (Medical Doctor), PharmD, PhD) or equivalent preferred + Minimum of 15 years' experience in the pharmaceutical or biotechnology setting within medical affairs strategy + Sr Director level medical affairs strategy experience for a minimum of 5 yrs. and experience in Medical Excellence & operations **Skills and Competencies:** + Demonstrated ability to lead and inspire high-performing teams + Strong strategic, operational, and leadership capabilities within a biotech or pharmaceutical setting + Expertise in navigating regulatory frameworks and ensuring compliance within medical affairs function + Excellent communication and interpersonal skills, with the ability to influence cross-functional teams + Strong analytical and problem-solving skills to address complex challenges within medical affairs + Ability to lead a team and influence organizational level decisions + Experience in collaborating with Medical Affairs vendors that can provide medical excellence related support + Strategic thinking acumen and record of accomplishment for operational excellence + Ability to rapidly pivot based on evolving corporate strategy and direction + Proficiency in pharma code and all guidelines concerning medical affairs activities + Excellent presentation skills and ability to communicate complex scientific information + Motivated, disciplined, pro-active individual capable of effectively managing timelines **Other Requirements:** + Ability to travel globally up to 25% for congresses, advisory board meetings, Governance meetings as business needs require **Competencies** **Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. **Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business. **Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders. **Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. **Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. **Empowered Development -** Play an active role in professional development as a business imperative. Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws. **Application Deadline** : This will be posted for a minimum of 5 business days. **Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; ********************************************* . **Disclaimer:** This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) . **Statement Regarding Job Recruiting Fraud Scams** At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

**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 and every day. **Position Overview:** The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence. This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used. **Key Responsibilities:** + **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency. + **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution. + **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through. + **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities. + **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI. + **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities. + **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities. **Qualifications:** + Bachelor's degree required; MBA or advanced degree preferred. + Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution. + Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required. + Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization. + Ability to focus on priorities and resolve operational issues effectively. + Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency. **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 $194,247.00 - Maximum $290,375.00, 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.

Under the direction of the Director/Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the oversight and management of Otsuka clinical studies, including coordination with other relevant parties (e.g., other Otsuka departments, external service providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH Guidelines Good Clinical Practices (GCP), and Otsuka SOPs, within agreed-upon timeframes and budget. **** - Provides oversight and management of clinical studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Otsuka SOPs. - Contribute to the development and review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents. - Provide input into and approval of the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites. - Provide leadership and guidance to clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Otsuka SOPs. - Communicates and coordinates clinical project-related activities and progress across all relevant cross-functional departments. - Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required. - Participate in forecasting study expenditures and resourcing needs. - Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast. - Provide timely communication of any variances in budget forecast to the Director/Associate Director. - Establish communication flow with CRO and investigative sites to maximize compliance with study protocol. - Provide oversight of ESP in its conduct of the day-to-day operations of assigned trial(s), as assigned. - Participates in ongoing review of clinical trial data focusing on data integrity, trending and consistency. - Supports project level inspection readiness activities, including responsibility for ensuring the completeness, timeliness and quality of the TMF. - Serve as Clinical Management representative for review of protocols within and across portfolios, as assigned. - Participate in program-level risk mitigation strategies and collaborate with ESPs on study-level risk mitigation and management activities. - Represent Clinical Management in departmental and cross-functional initiatives, as assigned. - Leads and/or contributes to assigned departmental, ESP and corporate standardization and continuous improvement efforts. - May have supervisory responsibilities including: + Coordinating the training and onboarding of new employee(s) on corporate culture, corporate goals/vision and departmental policies and processes. + Assuring compliance with departmental, SOP, compliance, and corporate training + Ensuring assigned staff have access to all required materials, systems, and training to complete job responsibilities. + Setting clear performance expectations and individual development plans and providing specific and frequent feedback to the employee on his/her performance. - Performs other duties, as assigned. **Qualifications/ Required** Knowledge/ Experience and Skills: - Comprehensive knowledge of clinical operations, drug development process, roles, and responsibilities of individuals within the project team, standard operating procedures (SOPs) and GCP/ICH regulations. - Thorough knowledge of contract research organizations (CROs), outsourcing, and evaluation of work performed against vendor Statement of Work (SOW). - Strong understanding of the clinical and scientific basis for assigned clinical program, with the ability to translate that knowledge in operational management. - Strong understanding of global regulatory requirements. - Strong communication, organization, planning, analytical, problem solving, and people management skills. - Demonstrated experience with working with the Microsoft suite of programs (e.g., Word, Excel, PowerPoint, Outlook, etc.) - Good understanding of clinical trial related software (e.g., eCRFs, IRT, CTMS, etc.). - Ability to travel up to 25%. **Educational Qualifications** Required: - Bachelor's Degree or Registered Nurse (RN). Minimum of 10 years industry experience with seven (7) years in clinical trial management experience. Preferred: - Previous supervisory experience. **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 $150,034.00 - Maximum $224,250.00, 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.

Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works collaboratively with members of the global regulatory team to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains regulatory intelligence, researches precedent approvals and prior health authority decisions to assess applicability to support development of strategic options for assigned Otsuka products. - Translates complex pertinent global requirements and provides an assessment of the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, etc.) to develop global regulatory plans, address global regulatory issues, health authority queries, and regulatory obligations. - Authors, coordinates, reviews, and executes submissions and responses to regulatory authorities related to INDs, amendments, supplements, aggregate reports, NDAs (as applicable) within company timelines and in accordance with regulations and guidelines. - Independently manages preparation of INDs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines. - Confirms submission documents are accurate, compliant, and high-quality to allow for smooth and expeditious approvals from regulatory authorities. - Serves as the sponsor point of contact to the health authority. - Represents GRA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with GRL, to determine appropriate actions to meet timelines and/or resolve issues. - Effectively manages and directs internal support staff and external consultants for assigned projects. - Interacts effectively with internal/external functional business units to gather data and develop documentation required for on-time submissions. - Works closely with GRA department to execute departmental initiatives to improve overall efficiency, quality, and/or output. - Assess and develop innovative ideas to move GRA department to address current and future challenges. **K** **nowledge, Skills, and Competencies** **K** **nowledge** - Experience working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, MAA). - RAC certification a plus. **Skills** - Strong oral and written communication skills. - Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines including FDA, ICH, etc. - Able to successfully interpret and apply regulatory intelligence to work output. - Ability to lead teams, prioritized work, proactively manage and communicate issues, scopes progress and risks throughout the project lifecycle ensuring key stakeholders are informed. - Able to establish close communications and working relationship with cross functional teams to meet business objectives. Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills with ability to learn and grow. - Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). **Competencies** See OPDC Competencies Chart (Level X) **P** **hysical Demands and Work Environment** Travel (approximately 20%) See document Physical Demands and Work environment for further requirements. **Education and Related Experience** Bachelor's degree with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (e.g., clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **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 $150,034.00 - Maximum $224,250.00, 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.

**Responsibilities** The Senior Manager, Biologics Drug Substance is responsible for mid-late stage biologic products development, including developing, optimizing and scaling up downstream or up stream bioprocesses for the commercial production of biologics, ensuring the robustness, scalability, and compliance of downstream or upstream operations. **** + Manage the technical aspects ofdownstream or upstream processoptimization, scale up andtechnology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Support process characterization(PC)andprocess validation activities (PPQ) fordownstreamprocesses executed at CDMOs. + Oversee thedownstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Act as thetechnicalleadfortrouble shooting ofdownstream process deviations or performance issues at CDMOs, including determination of product or process impact, root-cause analysis, and corrective action identification. + Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer andmaintainprocesses in the facility. **Qualifications** + Adegree in chemistry,biochemistry, chemicalengineering, or biologyand relevantpracticalexperience working inanc GMP regulated environment. + Bachelor'sdegree with10+ years ofworkexperience,or Master'sdegreewith7+years of workexperience, or PhD degree with 5+years of work experience. + For downstream:Experience withdownstream purification processdevelopment, processcharacterizationand validation + For upstream:Experience with cell line development, cell culture process development, cell culture processcharacterizationand validation. + Experienceofperformingprocessestechnical transfer and scale-up. + Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. + Strong communication, and interpersonal skills, with the ability to influence and collaborate effectively and professionally with a wide range of individuals and organizations, both internal and external. + Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment + Ability to work independently and multi-task in a fast-moving organization. + Ability to travel up to 25%. **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 $150,034.00 - Maximum $224,250.00, 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.

**Responsibilities** The Senior Manager, Biologics Drug Substance is responsible for mid-late stage biologic products development, including developing, optimizing and scaling up downstream or up stream bioprocesses for the commercial production of biologics, ensuring the robustness, scalability, and compliance of downstream or upstream operations. **** + Manage the technical aspects ofdownstream or upstream processoptimization, scale up andtechnology transfers to CDMOs, including documentation review, gap analysis, and risk assessment. + Support process characterization(PC)andprocess validation activities (PPQ) fordownstreamprocesses executed at CDMOs. + Oversee thedownstream manufacturing operations at CDMOs, including review of batch records, deviation investigations, and change controls. + Act as thetechnicalleadfortrouble shooting ofdownstream process deviations or performance issues at CDMOs, including determination of product or process impact, root-cause analysis, and corrective action identification. + Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer andmaintainprocesses in the facility. **Qualifications** + Adegree in chemistry,biochemistry, chemicalengineering, or biologyand relevantpracticalexperience working inanc GMP regulated environment. + Bachelor'sdegree with10+ years ofworkexperience,or Master'sdegreewith7+years of workexperience, or PhD degree with 5+years of work experience. + For downstream:Experience withdownstream purification processdevelopment, processcharacterizationand validation + For upstream:Experience with cell line development, cell culture process development, cell culture processcharacterizationand validation. + Experienceofperformingprocessestechnical transfer and scale-up. + Knowledge of the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. + Strong communication, and interpersonal skills, with the ability to influence and collaborate effectively and professionally with a wide range of individuals and organizations, both internal and external. + Ability to prioritize and manage multiple projects simultaneously, meet deadlines, and adapt to changing priorities in a dynamic environment + Ability to work independently and multi-task in a fast-moving organization. + Ability to travel up to 25%. **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 $150,034.00 - Maximum $224,250.00, 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 of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the impact of regulatory changes to the pharmaceutical environment. **** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated regulations and guidance that may impact pharmaceutical practices, procedures and controlled documents. + Lead weekly regulatory intelligence team meetings to include review and discussion of ad hoc query requests, regulatory background package requests, health authority guidance, Federal Register notices, public commenting opportunities, and newsletter content. + Manage development and distribution of weekly regulatory intelligence newsletters and regulatory watch notifications. + Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial, and public domain information resources to identify relevant regulatory-related news and information, and competitor product regulatory developments and report the most critical findings. + Discuss and triage any technical issues with the reg intel platform, access requests, and distribution issues. + Demonstrate comprehensive understanding of AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize regulatory intelligence information. + Monitor organizational strategic priorities and participate in cross-departmental discussions to consistently capture relevant and targeted regulatory intelligence. + Regularly review and update AI taxonomy terms relevant to Otsuka approved and investigational products, clinical, and business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and support Otsuka as a learning organization. + Maintain close communication with Informational Technology, Regulatory Technology, and the software vendor to maintain optimal functioning of the regulatory intelligence technology platform. + Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting of Otsuka comments to health authority websites. + Review and update Regulatory Intelligence homepage on GRA Collaboration Portal. + Manage onboarding and offboarding of regulatory intelligence team members, provide input on team member performance, establish annual budget, and manage spend. + Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. + Review overall quality of ad hoc query research for requested regulatory topics and confirm acceptability of responses. + Demonstrate understanding of the major regional and global industry association priorities (e.g., PhRMA, EFPIA, JPMA, etc.). + Demonstrate solid working knowledge of the drug, biologic, and device development process, laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming regulatory meetings/workshops/conferences remains current. **Qualifications** + Master's degree in a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** + Demonstrates the ability to plan, direct, organize, and coordinate projects. + Demonstrates experience interacting with and supporting senior leadership. + Previous experience with people management and team leadership. + Excellent interpersonal and communication skills, both written and verbal. + Previous experience developing newsletters is desirable. + Results driven and team-oriented collaborative approach required. + Critical thinking and problem-solving skills. + Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook). **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.

The Associate Director, Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products at CMOs under contract by Otsuka to ensure that they are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support, including oversight of upstream and downstream biologics manufacturing processes, ensuring compliance with biologics-specific GMP requirements. This role has global responsibility for directing clinical and commercial product quality to ensure global supply for Otsuka's patients. This role will also work collaboratively with other functional departments across Otsuka Affiliates and Subsidiaries to maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **** + Responsible for directing quality oversight of GMP contract manufacturers of Otsuka clinical and commercial products. + Develops comprehensive quality strategies for complex biologic development programs that address unique manufacturing challenges. + Establishes and maintain the effectiveness of Quality Systems for managing the batch record review and release process Quality Management Activities supporting all phases of clinical development as well as Commercial Product (API, drug product, and final finished product). + Transforms biologic manufacturing quality challenges through innovative approaches that maintain product integrity while optimizing operational efficiency. + Works collaboratively within the Global Quality Dept. and other functions within OAPI and OPDC to assure Compliance to ensure continuous improvement and compliance. + Manages reports and trends to the Management Representative to help in the preparation of Management reviews and/or other ad hoc reporting requests. + Establishes and maintains Standard Operating Procedures, work instructions, forms, templates and other documents associated with the systems noted above. + Improves supplier quality performance for batch record review and release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. + Interfaces with Contract Manufacturers/Laboratories, Tech Ops, Technical Services and Supply Chain Sourcing to drive Quality improvements that minimize the Costs of Quality, specifically component, materials or finished product deviations, OOS incidents, rejects, etc. + Represents global quality during execution of product technical transfer activities to ensure all aspects of the transfer are conducted per cGMP. + Assists in conducing audits of Contract Manufacturers/Laboratories (as part of an audit team) to ensure compliance with OAPI and OPDC requirements as well as applicable regulatory requirements. + Responsible for reviewing, drafting, and augmenting existing Quality agreements with external service providers to assure that full compliance and best practices as identified by Otsuka are communicated and continuously met. + Serves as a Global Quality Product Champion with a focus on ensuring the quality of our biologics products, monitoring, and escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial products, or patient safety. **Qualifications** Required + Bachelor's degree in Chemistry, Biology or other Physical Sciences. + Ten years of combined and/or pharmaceutical manufacturing, QA or QC assurance roles managing and directing quality oversight of commercial product and development project activities. + Seven years of product quality experience performing batch review and release activities of suppliers or contract manufacturers or equivalent preferred supporting commercial products and/or development projects. + Proven experience with biologics GMP manufacturing, including upstream (cell culture, bioreactors) and downstream (purification, filtration, formulation) processes. + Expertise in conducting root cause investigations and driving CAPA implementation. + Ability to supervise multiple direct reports and projects in a fast-paced environment. + Demonstrated success in working on and leading cross functional teams. + Experience with Pre Approval Inspections for NDAs and BLAs. + Experience in driving continuous improvement projects. + TrackWise Experience. + Excellent interpersonal and communication skills. + Position requires approximately 20% domestic travel; Occasional international travel may also be expected. Preferred + Advanced degree in Biology or other Physical Sciences. + Experience with quality oversight of controlled substances. **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 $146,955.00 - Maximum $219,650.00, 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.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** Purpose & Scope: We are seeking an experienced leader to serve as the Identity & Security Engineering Lead. This role will be responsible for defining strategy, leading teams, and ensuring operational excellence across our Microsoft identity management platforms while also overseeing broader security engineering domains including cloud security, OT security, application security, and infrastructure security. A critical focus area will be advancing our Multi-Factor Authentication (MFA), Conditional Access, and Privileged Access Management (PAM) capabilities to enable secure, seamless user experiences. Beyond identity, this leader will drive security engineering excellence across cloud, OT, and enterprise platforms. This role will be accountable for global delivery through a hybrid workforce model, managing both internal engineering teams and external service providers/partners across multiple regions and time zones. Operating within an agile delivery model, the Identity & Security Engineering Lead will ensure identity and security engineering capabilities are delivered with speed, adaptability, and business alignment. The role may be based in the United States, Canada, United Kingdom, Poland, Mexico, India, or Japan, with global responsibilities across all regions. Responsibilities and Accountabilities: Strategic Leadership * Define and execute the enterprise vision for Microsoft Identity platforms (Active Directory, Azure AD / Entra ID, M365 Identity Services, MFA, Conditional Access, PAM). * Lead strategy and delivery across broader security engineering domains including cloud security, OT security, and infrastructure/application security. * Drive a global MFA-first strategy, embedding Zero Trust principles across the enterprise. * Ensure identity and security engineering programs support digital transformation, cloud adoption, and regulatory compliance. Operational Excellence * Ensure global reliability and performance of MFA and Conditional Access policies. * Automate identity lifecycle management (provisioning, de-provisioning, access reviews, PAM). * Deliver security engineering solutions for cloud platforms (Azure, AWS, GCP) and OT/critical infrastructure environments. * Apply agile delivery methodologies to accelerate delivery, manage backlogs, and adapt quickly to evolving requirements. * Manage service delivery performance across both internal teams and external vendor partners. * Risk, Compliance & Governance * Partner with GRC to ensure identity and security engineering controls meet NIST CSF, ISO 27001, SOX, HIPAA, EU AI Act, and other regulatory frameworks. * Lead audit and compliance programs across identity, cloud, and OT security domains. * Anticipate and mitigate emerging risks by adapting MFA and security engineering strategies. Collaboration & Influence * Serve as a trusted partner across infrastructure, applications, OT, business stakeholders, and senior executives. * Position MFA, identity, and security engineering as key enablers of business productivity and compliance. * Represent the function in enterprise-wide programs including global network refresh, cloud adoption, OT modernization, and M&A integrations. * People & Talent Leadership * Lead and mentor a global team of internal and external resources, ensuring alignment and accountability across multiple regions and time zones. * Foster agile, cross-functional teams that collaborate across infrastructure, applications, and business domains. * Manage vendor partnerships and enforce accountability for quality, SLAs, and innovation. * Develop succession plans, training paths, and career opportunities in Microsoft identity, MFA, and advanced security engineering. * Promote a culture of inclusion, agility, innovation, and continuous improvement.