Senior Director, Global Safety Physician

Responsibilities: Provide medical oversight of safety data from trials, post-marketing sources, and literature Lead evaluation and management of safety signals and risk mitigation strategies Assess emerging safety findings and recommend regulatory actions Lead medical benefit-risk assessments informing development and lifecycle decisions Chair or participate in Safety Review Teams and escalate significant issues Author or review safety content for regulatory documents and submissions Provide medical safety expertise for regulatory filings and health authority interactions Contribute to product safety information, labeling, and risk management Support inspections and maintain scientifically defensible documentation Maintain awareness of new evidence and regulatory expectations Provide proactive safety input into clinical development plans and protocols Develop and execute medical safety strategy with cross-functional partners Evaluate emerging safety data to adjust monitoring or risk management Escalate complex safety cases and collaborate with PV Operations Provide safety expertise to governance committees and post-marketing activities Communicate safety findings to cross-functional teams and leadership Exercise independent medical judgment and challenge assumptions Mentor safety physicians and scientific colleagues; manage reports as assigned Foster collaboration, rigor, accountability, and continuous improvement in safety activities

Key requirements: MD or equivalent medical degree with clinical training Approximately 15+ years of clinical and pharmaceutical industry experience in safety or pharmacovigilance Demonstrated medical safety leadership on clinical development programs including post-marketing safety Strong grasp of global safety regulations (GCP, ICH E2, EU GVP, FDA) Expertise in safety signal evaluation, causality assessment, and risk mitigation Experience drafting or reviewing safety content for regulatory submissions and governance Working knowledge of safety databases (e.g., Argus, ArisGlobal), MedDRA, and safety surveillance methods Ability to work in global, matrixed organizations and influence decisions Strong clinical reasoning, analytical judgment, and timely decision-making Excellent written and verbal communication for diverse audiences Preferred: board-certified specialty training or relevant therapeutic area experience Preferred: experience with global regulatory submissions and health authority interactions Preferred: chairing or contributing to multidisciplinary safety governance meetings Preferred: people management experience and mentoring safety physicians Experience in growing biotechnology or specialty pharma contexts leadership and mentorship strong communication collaboration across functions pharmacovigilance risk management planning signal detection and evaluation