Senior Director, Global Medical Safety, Global Pharmacovigilance (psychedelics)

Otsuka America Pharmaceutical Inc.; Dover (DE); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan with match

Tuition reimbursement

Paid holidays and leave programs

Comprehensive life and disability ins.

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Medical Safety to lead safety strategy for late-stage psychedelic portfolios. You’ll monitor risk, guide regulatory submissions, and ensure scientific integrity in safety evaluations.

The role requires MD with US license, extensive PV expertise, and strong cross-functional collaboration across GRA, GCD, CM, and GPV teams. Remote option with global scope and leadership responsibilities.

Qualifications

• MD with medical license and at least 10 years in pharmacovigilance/med safety.
• Proven track record in global regulatory submissions (IND/NDA/MAA).
• Experience with psychedelic clinical programs is preferred.

Responsibilities

• Lead and advance safety strategy for late-stage psychedelic assets.
• Author and review safety content for regulatory submissions.
• Define safety monitoring and risk mitigation plans across programs.
• Represent Global Safety in regulatory interactions and governance meetings.
• Mentor GPV Associates and Safety physicians, and drive training.

Skills

Medical safety leadership

Clinical safety

Regulatory strategy

Cross-functional leadership

Risk management

Strategic thinking

Global/pharmacovigilance

Communication skills

Education

MD degree

US medical license

Job description

Remote

Full time

R12299

Senior Director, Global Medical Safety physician (psychedelics), 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, (eg acute altered states of consciousness, perceptual disturbances, emotional dysregulation, prolonged psychological effects, etc)
• 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 (Product Development Committee (PDC) and Research & Development Teams (RDT).
• 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; presenting and defending safety findings, emerging safety signals and benefit-risk evaluations, while providing clear scientific and clinical interpretation to enable regulatory decision making.
• Responsible for authoring safety surveillance plan and reviewing case report forms, investigator brochures, CSRs, package inserts, and NDA/PLA documents, including patient narratives.
• Responsible for medical analysis and assessing patient safety impact for product quality or other quality related events
• Keeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication.
• Represents GPV CS&PV at Labeling Committee/ Executive Committee discussions on new information impacting product profile.
• 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, including analysis of similar events in alert reports.
• 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, on the epidemiological and regulatory aspects of programs.
• 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

Knowledge:

• 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 (i.e. applying strategic planning, deployment and utilization of resources and technology to effectively fulfill the org/department’s mission).
• Proven business and market knowledge (i.e., understanding stakeholder needs regarding business environments and developing strategies to maximize value to the organization).
• 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.

Skills:

• Excellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
• Knows how/when to apply organizational policy or procedures to a variety of situations.

Competencies:

• 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.

Education and Related Experience:

• MD degree (required) with US medical license (preferred).
• Demonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry.
• Ability to act as in-house authority/leader in Global Pharmacovigilance; and be fully accountable for Safety of assigned products.
• High level of medical competence, with an ability to balance this with industry standards to achieve business goals.
• A thorough knowledge of the pharmaceutical/biopharmaceutical industry, especially clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal generation, safety evaluation, and risk management activities.
• Able to work across therapeutic areas and functions.
• Works collaboratively (establishes shared purpose across boundaries).
• Develops people and the organization (invests in long-term development of others).
• 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.

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.

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.

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.

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 [e-mail] .

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.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. 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.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan.

The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.