at Otsuka America Pharmaceutical Inc. in Topeka, Kansas, United States
Job Description
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.
+ Represent 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 w
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