Global Safety Program Lead

About the role

AstraZeneca is looking for a Global Safety Program Lead who reports to the Global Safety Head and is accountable for the safety strategy, delivery and oversight of assigned assets. 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, including GxP practice and local regulations.

Key responsibilities

• Own the scientific and clinical safety content for assigned assets and set safety team goals aligned to therapeutic area and product strategy
• Ensure high-quality delivery of the Safety & Strategy Management Team and Safety Surveillance Team outputs, including RMPs and PSRs, and lead responses to complex safety issues
• Represent the company at governance and advisory boards (DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT) and support regulatory submissions, health authority queries and ethics committee responses
• Contribute to study designs and concept delivery, and support safety medical directors and scientists through clinical programs
• Lead safety physicians and scientists in preclinical and clinical study monitoring, data interpretation, post-marketing surveillance and epidemiology
• Maintain global safety networks, advise on investigator-initiated trials and enable cross-functional, proactive team behaviour
• Implement new processes and systems, prioritise risk mitigation and troubleshooting

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 clinical safety delivery with strategic influence on studies and programs
• Ability to lead, coach and mentor 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 matrixed environments and influence on cross-functional leaders
• Desirable: PhD or complementary degree, conference speaking experience, clinical safety expertise in a disease area