Global Safety Program Lead, Senior Director

About the role

AstraZeneca is looking for a Global Safety Program Lead, Senior Director, who reports to the Global Safety Head and is accountable for the safety strategy, delivery and oversight of the assigned asset(s). The role works with safety physicians and scientists on safety strategy at asset and study level, line-manages a team of safety physicians and/or scientists and may deputise for the Global Safety Head. It operates under the highest ethical, quality and compliance standards, in line with global and local regulations, GxP practice and AZ procedures.

Key responsibilities

• Own the overall scientific and clinical safety content for the assigned asset(s) or indications, aligned to the GPT strategy, and set safety team goals
• Ensure high-quality delivery of the Safety & Strategy Management Team and Safety Surveillance Team for the assigned assets
• Own safety TPP, go/no-go criteria, safety messaging and toxicity management guidelines
• Represent the company at governance and advisory boards (DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT) and ensure quality of RMPs and PSRs and compliance with PV regulations
• Lead responses to complex technical safety issues and contribute to study designs and concept delivery
• Support safety medical directors and scientists through clinical programs, and lead safety physicians and scientists in study monitoring, data interpretation and post-marketing surveillance
• Ensure compliance with SHE standards and represent the company in regulatory submissions, health authority queries and ethics committee interactions
• Implement new processes and systems, prioritise risk mitigation and troubleshoot effectively
• Deliver clinically sound analyses of safety data, interpret risks and inform the label globally

Required profile

• Medical degree or equivalent in biomedicine or science
• 5 years of extensive clinical, safety and risk management experience in pharma, biotech, CRO, academia or health authorities
• Proven track record of successful clinical safety delivery with strategic influence on studies and programs
• Experience leading, coaching and mentoring safety medical directors and scientists
• Willingness to travel domestically and internationally
• Ability to present complex topics to senior leaders at safety and development governance meetings

Required skills

• Thorough knowledge of global pharmacovigilance and safety deliverables, standards and processes, including pre- and post-launch
• Experience of global regulatory submissions and interaction with major regulatory agencies
• Collaboration across a matrixed environment and influence on cross-functional leaders (Clinical Development, Medical Affairs, Regulatory Affairs)

Preferred: PhD or other complementary degree, excellent speaking skills and conference experience, and clinical safety expertise in an appropriate disease area. Applications close on 30 December 2026.