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Job description
Remote
nFull time
nR12299
nSenior 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.
nThis 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.
nKey Job Responsibilities
nnnServes as the medical safety expert for assigned products for late stage development through commercialization.
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nnMaintains accurate and complete knowledge of assigned investigational and marketed products, being monitored by Otsuka, co-marketers, cosponsors, and/ or affiliates.
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nnDevelops and leads global safety strategy for late-stage psychedelic development portfolio.
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nnDevelops safety monitoring approach for psychedelic class, (eg acute altered states of consciousness, perceptual disturbances, emotional dysregulation, prolonged psychological effects, etc)
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nnPartners with GCD, CM and GRA to define appropriate therapist/guide escalation procedures and emergency intervention frameworks.
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nnDevelops integrated benefit-risk frameworks tailored to psychedelic-assisted therapies and novel neuropsychiatric mechanisms.
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nnServes as the safety representative on asset strategy and governance teams (Product Development Committee (PDC) and Research & Development Teams (RDT).
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nnContributes to TrPP and overall development strategy.
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nnEstablishes standards for psychological safety monitoring before, during and after dosing sessions.
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nnChairs product level safety governance cross-functional meetings
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nnProvides 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.
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nnRepresent 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.
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nnResponsible for authoring safety surveillance plan and reviewing case report forms, investigator brochures, CSRs, package inserts, and NDA/PLA documents, including patient narratives.
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nnResponsible for medical analysis and assessing patient safety impact for product quality or other quality related events
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nnKeeps abreast of industry standards and initiatives regarding signal detection, risk management, and risk communication.
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nnRepresents GPV CS&PV at Labeling Committee/ Executive Committee discussions on new information impacting product profile.
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nnManages the continuous analysis of adverse events to identify signals and trends for assigned products.
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nnPerforms review and approval of clinical trial medical coding.
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nnParticipates in the creation and revisioning of SOPs.
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nnProvides strategic input on safety issues during development portfolio reviews and governance meetings.
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nnPrepares/review safety summaries for inclusion in medical information write-ups, including analysis of similar events in alert reports.
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nnProvides 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.
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nnKeeps management informed of any critical safety issues on monitored products.
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nnServes as mentor and resource for GPV Associates, Scientists and Safety physicians.
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nnParticipates in providing training to GPV team members and other Otsuka staff as appropriate, on the epidemiological and regulatory aspects of programs.
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nnParticipates in inspection and audit readiness activities as medical safety subject matter expert.
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nnUtilizes technical/medical knowledge to assist GPV team members in the assessment of adverse event reports.
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nnKeeps abreast of current developments in the field and maintains knowledge base by attending seminars, professional association meetings, and maintaining industry and professional network.
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n nKey Experience and Leadership Requirements
nRequired
nnnAbility to lead and operate in a highly ambiguous and evolving regulatory and scientific space
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nnStrong decision-making ability within a rapidly evolving external landscape
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nnExceptional communication and cross-functional collaboration
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nnAbility to influence without authority
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n nPreferred
nnnPsychedelic-assisted therapy clinical trial experience
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nnKnowledge of controlled substance regulations and DEA requirements
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nnExperience with suicidality monitoring tools (C-SSRS, etc.) and abuse liability monitoring
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n nKnowledge, Skills, Competencies, Education, and Experience
nKnowledge:
nnnRequires a strong medical background evidenced by clinical training.
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nnProven track record of innovation in Medical Safety strategy, implementation and execution.
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nnProven strategic resource management experience (i.e. applying strategic planning, deployment and utilization of resources and technology to effectively fulfill the org/department's mission).
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nnProven business and market knowledge (i.e., understanding stakeholder needs regarding business environments and developing strategies to maximize value to the organization).
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nnSolid knowledge of FDA and global PV regulations.
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nnKnowledge of clinical trials, good clinical practices, and ICH guidelines.
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nnExperience in preparing and reviewing safety content for global regulatory filings (IND/NDA/MAA).
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nnExperience of working in a global setting.
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n nSkills:
nnnExcellent technical skills, including the ability to comprehend and integrate scientific data from a variety of sources.
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nnKnows how/when to apply organizational policy or procedures to a variety of situations.
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n nCompetencies:
nnnSelf-starter with proven ability to thrive in a fast-paced team environment handling multiple simultaneous high priority tasks.
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nnAbility to adapt to a dynamic work environment and drive safety initiatives.
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n nEducation and Related Experience:
nnnMD degree (required) with US medical license (preferred).
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nnDemonstrated experience (at least 10 years) as a Safety/PV professional in pharmaceutical industry.
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nnAbility to act as in-house authority/leader in Global Pharmacovigilance; and be fully accountable for Safety of assigned products.
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nnHigh level of medical competence, with an ability to balance this with industry standards to achieve business goals.
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nnA 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.
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nnAble to work across therapeutic areas and functions.
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nnWorks collaboratively (establishes shared purpose across boundaries).
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nnDevelops people and the organization (invests in long-term development of others).
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nnExperience interacting with global regulatory authorities.
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n nPhysical Demands and Work Environment
nnnTravel (approx 20%) as and when required.
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nnGlobal role which requires occasional after-hours meetings with Japan.
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n nCompetencies
nAccountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
nStrategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
nPatient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
nImpactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
nRespectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
nEmpowered Development - Play an active role in professional development as a business imperative.
nMinimum $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.
nApplication Deadline : This will be posted for a minimum of 5 business days.
nCompany 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.
nCome discover more about Otsuka and our benefit offerings; .
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nDisclaimer:
nThis 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.
nOtsuka 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.
nIf 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 .
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nOtsuka 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.
nDriven 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.
nOPDC 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.
nWe 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.
Worksite address
pierre, SD, 57501, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.