Senior Medical Director, Therapeutic Area Safety Physician - Oncology and Neurology

Responsibilities:

Therapeutic Area Medical Safety Leadership

• Serve as the senior Medical Safety Physician for assigned therapeutic areas, providing medical safety leadership across clinical development and post-marketing activities
• Develop and execute medical safety strategies aligned with program development plans, product lifecycle objectives, and applicable regulatory requirements
• Provide independent medical assessment of emerging safety information, potential risks, and evolving benefit–risk considerations
• Identify and proactively communicate important safety issues, trends, and emerging risks to appropriate governance bodies and senior leadership
• Ensure appropriate escalation of significant or potentially significant safety concerns to the Lead Medical Safety Physician and relevant safety governance forums

Signal Evaluation & Surveillance

• Lead or contribute to signal detection, validation, evaluation, and ongoing safety surveillance for assigned products and therapeutic areas in partnership with Safety Science
• Evaluate cumulative and emerging safety data from clinical trials, post-marketing sources, literature, epidemiologic data, and other relevant sources
• Provide medical input into safety topics, emerging risks, and potential signals, including assessment of clinical relevance and implications for patient safety
• Ensure appropriate documentation and communication of medical safety conclusions and recommendations

Benefit–Risk Assessment & Risk Management

• Lead medical safety input into ongoing benefit–risk assessments for assigned programs
• Provide safety expertise for development decisions, including protocol design, eligibility criteria, monitoring strategies, dose selection, and risk mitigation approaches
• Provide medical safety input into Risk Management Plans, risk minimization strategies, safety specifications, and other risk-management activities as applicable
• Ensure safety risks and mitigation strategies are appropriately reflected in protocols, Investigator’s Brochures, Clinical Study Reports, regulatory submissions, and other relevant documents

Cross-Functional Therapeutic Area Leadership

• Serve as the primary Medical Safety Physician partner to Clinical Development Therapeutic Area Medical Leads for assigned programs
• Establish strong, constructive partnerships with Clinical Development, Medical Affairs, Regulatory, Clinical Operations, Biostatistics, Data Management, and other functions
• Integrate safety insights into broader therapeutic area and asset strategies while maintaining independent medical safety judgment
• Represent Medical Safety in program team meetings, development governance forums, and cross-functional decision-making
• Partner with Medical Affairs to support medically accurate and consistent safety communication across internal and external materials

Regulatory & Safety Governance

• Provide medical safety leadership and input into DSURs, PADERs/PBRERs, Clinical Evaluation Reports, safety sections of regulatory submissions, and other aggregate safety reports
• Provide medical input for responses to health authority safety questions and participate in regulatory interactions as appropriate
• Provide medical safety leadership within product- or program-level safety governance activities, including evaluation of emerging safety issues, benefit-risk assessments, and safety-related development decisions
• Ensure safety decisions are appropriately documented, supported by available evidence, and escalated when necessary
• Support inspection and audit readiness and participate in health authority inspections or audits as appropriate

Organization Leadership

• Provide leadership, coaching, and mentoring to Medical Safety Physicians and other safety professionals
• Where applicable, directly manage Medical Safety Physicians and contribute to performance management, talent development, and succession planning
• Serve as a senior medical safety resource and subject matter expert
• Contribute to the development and implementation of Medical Safety standards, operating procedures, training programs, and quality initiatives
• Promote consistency and high-quality medical safety practices across therapeutic areas while identifying opportunities for continuous improvement
• Partner with the Lead Medical Safety Physician on organizational scaling, resource planning, capability development, and strategic priorities

Preferred Skills, Qualifications and Technical Proficiencies:

• Therapeutic area medical safety leadership
• Strong clinical and scientific judgment
• Benefit-risk and medical decision-making
• Signal evaluation and safety surveillance
• Cross-functional influence and collaboration
• Strategic thinking and execution
• Leadership, mentoring, and talent development
• Clear, concise, and effective communication
• Ability to operate effectively in a fast-paced, evolving environment

Preferred Education and Experience:

• MD or equivalent medical degree required; board certification preferred
• 10+ years of relevant experience in the biotechnology or pharmaceutical industry, including substantial experience in pharmacovigilance, drug safety, or medical safety
• Extensive experience providing strategic medical safety oversight across clinical development and/or post-marketing programs
• Strong experience in medical case review, signal evaluation, safety surveillance, and benefit–risk assessment
• Demonstrated experience providing medical safety leadership within one or more therapeutic areas and working with cross-functional development teams
• Demonstrated experience supporting NDA and/or MAA filings, including development of safety content and responses to regulatory questions
• Strong understanding of global pharmacovigilance regulations and safety requirements
• Experience contributing to regulatory submissions and health authority interactions
• Demonstrated leadership, mentoring, and/or people management experience
• Ability to exercise independent medical judgment while operating effectively within a highly collaborative, matrixed organization
• Experience in a growing biotechnology or pharmaceutical organization preferred