Senior Medical Director, Product Safety Physician Lead

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Medical Director, Product Safety Physician Lead based in the United States.

This senior medical leadership role serves as the Product Safety Physician Lead for multiple or strategically important developmental programs, often spanning multiple indications. You will provide scientific and medical leadership across the product lifecycle, with a strong focus on early development and patient safety. The role is responsible for establishing an integrated global interpretation of safety data and guiding benefit-risk assessments.

You will work across Clinical Development, Medical Affairs, Pharmacovigilance, Regulatory, Epidemiology, and other cross-functional teams. The position combines strategic leadership, regulatory engagement, safety governance, and hands‑on medical review in a highly collaborative matrix environment. You will also mentor safety professionals and help strengthen organizational capabilities, processes, and standards. This is an opportunity to influence critical development decisions and help advance innovative therapies for patients with serious diseases.

• Serve as the Product Safety Physician Lead for multiple or large, complex, and strategically important developmental programs, establishing and maintaining a unified global interpretation of product safety data.
• Lead benefit-risk oversight throughout the product lifecycle, with particular emphasis on early‑stage development and proactive identification and management of emerging safety concerns.
• Chair Safety Management Team meetings, develop and communicate safety perspectives, review meeting materials, and represent product safety considerations to senior governance bodies.
• Represent assigned programs at Company Safety Committee meetings and contribute to meeting preparation, agenda development, recommendations, and follow‑up actions.
• Participate in external and internal safety monitoring committees, providing medical interpretation of safety data, leadership, recommendations, and input into committee charters.
• Lead communication of safety recommendations to labeling teams and other relevant stakeholders, including development and maintenance of Company Core Safety Information and related labeling materials.
• Lead product safety issue management, including escalation, risk assessment, response strategy, regulatory inquiries, issue documentation, crisis response planning, and communication with internal and external stakeholders.
• Review and guide responses to regulatory agency inquiries, contributing to formal responses and participating in regulatory meetings as the safety representative.
• Provide medical review and escalation guidance for serious adverse events and other safety reports, determining when additional evaluation or escalation is required.
• Collaborate on clinical trial design and documentation, including protocols, Investigator's Brochures, informed consent materials, safety monitoring plans, and risk management strategies.
• Define and oversee safety data requirements, endpoints, inclusion and exclusion considerations, medical monitoring criteria, and safety‑related elements of clinical data management plans and case report forms.
• Lead interpretation of ongoing clinical safety data, including serious adverse events, laboratory abnormalities, aggregate safety analyses, and protocol‑specific surveillance activities.
• Provide safety input into Clinical Study Reports, Summary of Clinical Safety documents, Integrated Summary of Safety materials, Development Safety Update Reports, and regulatory filing activities.
• Develop and maintain Product Safety Strategies, Safety Surveillance Plans, Risk Management Plans, events of interest, product safety profiles, and related pharmacovigilance documentation.
• Lead safety assessments of internal, external, healthcare professional, and consumer inquiries, determining data requirements and overseeing appropriate responses.
• Monitor competitor safety profiles, labeling, public information, and emerging safety findings to support strategic product…