Senior Director, Global Medical Safety, Global Pharmacovigilance

Senior Director, Global Medical Safety Physician Senior Director, Global Medical Safety physician, leads and supports safety team(s) in all aspects of pharmacovigilance and risk management activities for assigned products, both marketed and in development. This role will provide proactive strategic and operational safety leadership for Otsuka's late-stage psychedelic development portfolio (~4 assets). S/he will serve as the medical safety lead for investigational psychedelic compounds, ensuring proactive identification, assessment, communication and mitigation of safety risks in a highly specialized and evolving therapeutic landscape. The role requires deep expertise in clinical safety, neuropsychiatric risk assessment and benefit-risk evaluation, strong strategic mindset combined with the ability to navigate the unique clinical, operational, ethical and regulatory considerations associated with psychedelic compounds. S/he will establish a robust safety strategy that supports accelerated development, while maintaining the highest standards of patient safety and scientific integrity. The Safety physician will partner closely with the Medical Safety Therapeutic Area Lead, Head of Medical Safety, Head of Global PV (GPV), Global Clinical Development (GCD), Clinical Management (CM) and Global Regulatory Affairs (GRA) Biometrics, and Translation Medicine to identify, evaluate and communicate safety issues relevant to psychedelic portfolio. Key Job Responsibilities:

• Serves as the medical safety expert for assigned products for late stage development through commercialization.
• Maintains accurate and complete knowledge of assigned investigational and marketed products, being monitored by Otsuka, co-marketers, cosponsors, and/ or affiliates.
• Develops and leads global safety strategy for late-stage psychedelic development portfolio.
• Develops safety monitoring approach for psychedelic class.
• Partners with GCD, CM and GRA to define appropriate therapist/guide escalation procedures and emergency intervention frameworks.
• Develops integrated benefit-risk frameworks tailored to psychedelic-assisted therapies and novel neuropsychiatric mechanisms.
• Serves as the safety representative on asset strategy and governance teams.
• Contributes to TrPP and overall development strategy.
• Establishes standards for psychological safety monitoring before, during and after dosing sessions.
• Chairs product level safety governance cross-functional meetings.
• Provides strategic regulatory safety leadership and authors safety content for Phase 2/3 protocols as well as global regulatory submissions, including INDs, NDAs, MAAs and other health authority filings.
• Ensures safety sections are scientifically robust, regulatory-compliant and aligned with overall development and registration strategy.
• Represents Global Safety in regulatory interactions.
• Manages the continuous analysis of adverse events to identify signals and trends for assigned products.
• Performs review and approval of clinical trial medical coding.
• Participates in the creation and revisioning of SOPs.
• Provides strategic input on safety issues during development portfolio reviews and governance meetings.
• Prepares/review safety summaries for inclusion in medical information write-ups.
• Provides medical analysis and decision making for the development and maintenance of the Company Core Data Sheet, risk management plans (RMPs/REMS) and individual case safety reports.
• Keeps management informed of any critical safety issues on monitored products.
• Serves as mentor and resource for GPV Associates, Scientists and Safety physicians.
• Participates in providing training to GPV team members and other Otsuka staff as appropriate.
• Participates in inspection and audit readiness activities as medical safety subject matter expert.
• Utilizes technical/medical knowledge to assist GPV team members in the assessment of adverse event reports.
• Keeps abreast of current developments in the field and maintains knowledge base by attending seminars, professional association meetings, and maintaining industry and professional network.

Key Experience and Leadership Requirements:

• Required Ability to lead and operate in a highly ambiguous and evolving regulatory and scientific space
• Strong decision-making ability within a rapidly evolving external landscape
• Exceptional communication and cross-functional collaboration
• Ability to influence without authority
• Preferred Psychedelic-assisted therapy clinical trial experience
• Knowledge of controlled substance regulations and DEA requirements
• Experience with suicidality monitoring tools (C-SSRS, etc.) and abuse liability monitoring

Knowledge, Skills, Competencies, Education, and Experience:

• Requires a strong medical background evidenced by clinical training.
• Proven track record of innovation in Medical Safety strategy, implementation and execution.
• Proven strategic resource management experience.
• Solid knowledge of FDA and global PV regulations.
• Knowledge of clinical trials, good clinical practices, and ICH guidelines.
• Experience in preparing and reviewing safety content for global regulatory filings (IND/NDA/MAA).
• Experience of working in a global setting.
• Excellent technical skills.
• Self-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks.
• Ability to adapt to a dynamic work environment and drive safety initiatives.
• MD degree (required) with US medical license (preferred).
• Demonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry.
• Able to work across therapeutic areas and functions.
• Works collaboratively.
• Develops people and the organization.
• Experience interacting with global regulatory authorities.

Physical Demands and Work Environment:

• Travel (approx 20%) as and when required.
• Global role which requires occasional after-hours meetings with Japan.

Competencies:

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development

Compensation: Minimum $249,973.00 - Maximum $388,125.00, 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. Apply To This Job