Senior Director, Global Safety Physician

Medical Oversight & Signal Management

• Provide medical oversight of assigned products, including review and interpretation of safety data from clinical trials, post-marketing sources, and scientific literature.
• Provide medical leadership in the evaluation and management of safety signals, working with safety scientists responsible for routine surveillance and process execution.
• Assess emerging safety findings, determine their medical significance, and recommend appropriate risk mitigation and regulatory actions.
• Lead medical benefit-risk assessments for assigned products, integrating clinical, nonclinical, and post-marketing evidence to inform development and lifecycle decisions.
• Serve as a key member or designated chair of Safety Review Teams (SRTs), presenting evidence-based recommendations and escalating significant issues through established governance.

Regulatory & Scientific Contributions

• Author or medically review safety content in key regulatory documents, including DSURs, PBRERs, RMPs, IBs, clinical study reports, and regulatory submissions.
• Provide medical safety expertise for regulatory filings and interactions, including INDs, NDAs/BLAs, marketing authorization applications, and responses to health authority inquiries.
• Contribute to product safety information, labeling, and risk management strategies throughout the product lifecycle.
• Support inspections and audits as the medical safety subject-matter expert, ensuring assessments, decisions, and supporting documentation are scientifically defensible and inspection-ready.
• Maintain awareness of emerging scientific evidence, therapeutic developments, and regulatory expectations relevant to assigned products.

Cross-functional Collaboration

• Provide proactive medical safety input into clinical development plans, study protocols, safety monitoring, stopping rules, and risk mitigation strategies.
• Develop and execute medical safety strategy for assigned products and studies, partnering with Clinical Development, Biostatistics, Regulatory Affairs, and other stakeholders.
• Evaluate emerging safety data to inform clinical development decisions and recommend changes to monitoring or risk management as appropriate.
• Serve as an escalation point for complex or clinically significant safety cases from internal and external medical review teams; collaborate with PV Operations and safety scientists to support consistent evaluations.
• Provide medical safety expertise to cross-functional governance committees and collaborate with Medical Affairs on relevant post-marketing safety activities.
• Communicate safety findings, benefit-risk considerations, and actionable recommendations clearly to cross-functional teams, safety governance forums, and senior leadership.
• Exercise independent medical judgment, constructively challenge assumptions, and influence decisions through balanced scientific reasoning.
• Identify and escalate significant safety concerns promptly, providing clear, actionable recommendations.
• Foster collaboration, scientific rigor, accountability, and continuous improvement across safety activities.
• Mentor safety physicians and scientific colleagues, sharing medical expertise and supporting their development; manage direct reports where assigned.