Global Safety Program Lead/Sr Medical Director

Responsibilities

• Accountable for the overall scientific and clinical safety strategy, delivery, and oversight of assigned assets or indications
• Line manage a team of safety physicians and scientists, providing coaching and mentorship
• Lead the implementation and high-quality delivery of Safety & Strategy Management Teams (SSaMT) and Safety Surveillance Teams
• Act as the primary safety expert for project representation at governance forums, including DRC, eCRC, and DSMB/DMC
• Ensure the quality of key safety deliverables, including Risk Management Plans (RMPs) and Periodic Safety Reports (PSRs)
• Drive the analysis and interpretation of clinical safety data to inform product labeling and risk mitigation strategies
• Represent the company in regulatory submissions and respond to Health Authority queries and Ethics Committees

Requirements

• Medical degree (MD) or equivalent degree in biomedicine or science
• 5+ years of extensive clinical safety and risk management experience within the pharmaceutical, biotech, or CRO industry
• Proven track record of successful clinical safety delivery and strategic influence on clinical programs
• Thorough knowledge of global pharmacovigilance standards, processes, and regulatory requirements
• Experience with global regulatory submissions and interacting with major regulatory agencies
• Demonstrated ability to lead, coach, and mentor safety medical directors and scientists
• Ability to collaborate and influence cross-functional leaders in a matrixed environment
• Willingness to travel domestically and internationally

Preferred Qualifications

• PhD or other complementary advanced scientific degree
• Demonstrated clinical safety and research expertise in a specific disease area
• Experience presenting complex scientific topics to senior leadership and at industry conferences

About the Company

AstraZeneca is a science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals.