Lead Medical Safety Physician

Responsibilities

• Define and drive the medical safety strategy across the portfolio
• Provide senior medical safety leadership for safety interpretation and benefit–risk assessment
• Ensure consistent medical oversight of clinical and post-marketing safety activities
• Lead, build, and develop a team of Medical Safety Physicians
• Set standards for medical review quality and consistency
• Scale the organization to support portfolio and geographic growth
• Lead medical evaluation of safety signals in partnership with Safety Science
• Ensure robust benefit–risk assessment across programs
• Integrate clinical interpretation into safety surveillance outputs
• Partner with Clinical Development to integrate safety into development strategy
• Partner with Medical Affairs to ensure consistent safety messaging
• Provide medical interpretation and benefit–risk input to cross-functional decisions
• Oversee medical input into DSURs, PADERs, and regulatory safety submissions
• Support health authority interactions and safety queries
• Contribute to cross-functional safety governance forums, providing medical expertise and benefit–risk input
• Identify and escalate safety risks at product and portfolio level
• Define medical risk mitigation strategies with cross-functional partners
• Drive continuous improvement in medical safety processes and standards

Qualifications

• MD required; board certification in a relevant specialty strongly preferred
• 12+ years of progressive leadership experience in the pharmaceutical or biotechnology industry, including significant experience in Medical Safety and pharmacovigilance; oncology experience required
• Deep expertise in safety signal management, medical review, aggregate safety assessment, and benefit–risk evaluation across clinical development and post-marketing products
• Extensive experience interacting with global health authorities and leading safety-related regulatory activities
• Strong understanding of global pharmacovigance regulations and industry best practices
• Proven ability to influence cross-functional and executive-level decision-making and build effective partnerships across Patient Safety/Pharmacovigilance, Clinical Development, Regulatory Affairs, Medical Affairs and Biometrics
• Experience building, scaling, or leading Medical Safety functions in fast-paced or growing organizations preferred