The Senior Medical Director, Therapeutic Area Safety Physician provides senior medical safety leadership within assigned therapeutic areas for clinical development program(s) and, as applicable, post-marketing pharmacovigilance activities. Reporting to the Lead Medical Safety Physician, this role provides strategic medical oversight of safety surveillance, safety analyses, emerging safety issues, and benefit–risk assessment.

The role partners closely with Safety Science, Clinical Development, Medical Affairs, Regulatory, Safety Operations, and Medical Review to ensure integrated, medically sound assessment of safety information and appropriate incorporation of safety considerations into development and lifecycle decisions. The role serves as a senior medical safety leader for assigned therapeutic areas and programs, providing medical leadership for safety strategy, benefit-risk assessment, governance activities, and cross-functional decision-making throughout the product lifecycle.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $298,000- $350,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.