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 and development of a world-class safety epidemiology and real-world evidence capability.
• Establish and manage master service agreements with external providers as required. 
• Strengthen AstraZeneca’s reputation and expertise in epidemiology policy, planning and evidence generation through participation in relevant external forums and professional groups.

Provide line management for Safety Epidemiology team members, including:

• Promote effective communication within and across departments.
• Recruit, retain and develop staff through targeted capability-building and career opportunities.
• Manage performance, complete assessments and make reward recommendations for direct reports.
• Implement and administer organisational policies.
• Maintain an environment that attracts, develops and retains highly qualified employees.
• Ensure direct reports adhere to SHE standards and maintain an appropriate work–life balance.
• Maintain effective succession plans.

The Senior Director will lead a team of 10–20 epidemiologists and oversee contracted resources as needed.

Requirements:

• Ph.D. in epidemiology and experience in the health care environment. Alternatively, an MSc or MPH with substantial experience in the health care environment or equivalent.
• Proven leadership experience in Safety Epidemiology, Pharmacoepidemiology or Real-World Evidence within the pharmaceutical or healthcare sector.
• Extensive experience working with primary and secondary data, both US and global. 

• Significant relevant hands on experience in the pharmaceutical/biotechnology industry

• Experience managing external partnerships and service providers, including master service agreements.
• Line management experience
• Experience of regulatory interactions
• Experience managing external partnerships and service providers, including master service agreements.
• Experience leading post-authorization safety studies or regulatory commitments
• Ability to interact externally with key customers, including congress presentations.

• Persuasive communicator in English with a proven ability to work collaboratively in a multi-cultural environment
• Experience, leading, promoting, motivating and empowering others to accomplish individual, team and organisational objectives
• Ability to develop and drive safety epidemiology and business strategy and persuade tactfully, to obtain desired outcomes while maintaining effective, positive organisational relationships
• In-depth specialist knowledge of epidemiological methods and its application to support pharmaceutical development and regulatory approval at an international level
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment
• Able to influence others at a senior level across the business in order gain commitment to strategy
• Proven teamwork and collaboration skills

In Office Requirement:

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Competitive salary and benefits package on offer.

The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, A performance recognition scheme and a competitive, generous remuneration package.

Date Posted

Closing Date