Senior Director Safety Epidemiology

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About the role

Senior Director Safety Epidemiology Cambridge, UK (3 days on site per week)   About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we are pioneering new frontiers by identifying and treating patients earlier, working towards the aim of eliminating cancer as a cause of death.   Come and join our AZ team where you will play a pivotal role in this exciting period of development!!   AstraZeneca’s Safety Epidemiology team is a global group of PhD-trained pharmacoepidemiologists with expertise in evidence synthesis and analytics. The team plans and delivers R&D safety epidemiology activities that inform the benefit–risk profiles of nearly 100 marketed and pipeline products. These activities include local and global post-authorisation regulatory commitment studies (PARCS) submitted to health authorities such as the FDA and EMA. As study leads, the team ensures that PARCS design, execution, analysis and reporting meet rigorous scientific standards and agreed timelines.   It is a pivotal scientific leadership role within Global Patient Safety, accountable for the strategic, scientific and operational delivery of Safety Epidemiology contributions across AstraZeneca’s therapeutic portfolio. The role will embed AI into routine workflows to improve the efficiency and cost-effectiveness of licence-to-operate activities, including PASS and PMS, while strengthening earlier, high-value epidemiological contributions where appropriate, to earlier-stage development activities such as predictive safety, target product profiles and clinical study design.   The Senior Director develops and leads global pharmacovigilance epidemiology strategy and deliverables in partnership with Patient Safety and Regulatory leaders, providing scientific guidance as needed. The role also coordinates with local markets on mandated PARCS that require local real-world evidence. Working across Global Patient Safety, Regulatory, Global and Local Medical, and R&D, the Senior Director shapes strategic epidemiology and pharmacovigilance study plans and ensures that studies are designed and delivered in accordance with regulatory requirements and anticipated requests from the EMA, FDA and other health authorities.   Key Responsibilities: • Deliver high-quality, scientifically robust evidence on time and within budget. • Ensure projects are appropriately resourced. • Develop and execute the Safety Epidemiology strategy in collaboration with senior leaders across Global Patient Safety, Medical Affairs and Clinical. Use AI to scale evidence generation and analytical workflows, expand internal capacity, and reduce costs. • Recruit and assign epidemiologists with the appropriate skills to deliver Safety Epidemiology activities against quality, timeline, budget and performance targets. • Partner with cross-functional teams to determine project resource needs. • Develop and maintain the Safety Epidemiology capability strategy, proactively addressing skills gaps through training, capability-building and partnerships. • Partner with Capacity Management to forecast resources accurately and develop flexible staffing solutions that support project delivery, employee development and succession planning. • Motivate and develop team members, providing guidance on relevant Individual Development Plans. • Ensure compliance with applicable policies and SOPs. • Provide technical and strategic direction through coaching and leadership review of key deliverables, including MARC materials. • Help drive the strategic vision

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