Global Safety Program Lead

Position: Global Safety Program Lead

Location: Cambridge, UK
Competitive salary and excellent company benefits

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. Within Global Patient Safety, you will shape the safety strategy of high-impact assets and lead cross-functional teams to optimize benefit–risk and maintain competitive advantage across development and post‑marketing.

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.

Accountabilities

In this role, you are accountable to the Global Safety Head for the end‑to‑end safety strategy, delivery, and oversight of assigned asset(s) across pre‑clinical, clinical, and post‑marketing. You will:

• Lead the Safety Strategy & Management Team (SSaMT) and Safety Surveillance Team for assigned asset(s), setting safety goals aligned to therapeutic area and product strategy, and ensuring high‑quality, compliant delivery of safety activities.
• Own the scientific and clinical safety content for the asset(s), including safety TPP, safety Go/No‑Go criteria, toxicity management guidelines, and safety messaging, integrating inputs from clinical, epidemiology, pre‑clinical, and literature.
• Represent Global Patient Safety at key governance and external forums (e.g., DRC, eCRC, SARB, FSIRB, DSMB/DMC, MARC, CPT, GPT, Advisory Boards) in partnership with the Global Safety Head; lead responses to complex technical safety issues.
• Ensure the quality, compliance, and timely delivery of safety documents (e.g., RMPs, PSURs/PSRs) and safety contributions to study design, protocol concepts, regulatory submissions, HA/EC queries, and labeling for global markets.
• Provide strategic safety leadership to safety medical directors and scientists, guiding study and program execution, data monitoring and interpretation, signal management, and post‑marketing surveillance to inform labeling and risk minimization.
• Build and maintain strong internal and external networks, including alliance partners, to drive proactive, cross‑functional, solution‑oriented safety actions; may support due diligence and in‑licensing assessments.
• Line manage and develop a team of safety physicians and/or scientists; embed new processes, systems, and ways of working; prioritize risk mitigation and effective issue resolution; operate to the highest ethical, quality, GxP, and AZ standards.

Essential for the role

• Medical degree or equivalent degree in biomedicine or science, with extensive clinical safety/pharmacovigilance experience.
• Strong relevant experience in clinical safety and risk management across pharma/biotech/CRO/academia/Health Authorities, spanning pre‑ and post‑launch.
• Proven track record of leading asset safety strategy and delivery, with demonstrated strategic influence on clinical studies/programs and benefit–risk decisions.
• Deep knowledge of global PV regulations, standards, and safety deliverables (e.g., RMPs, PSURs/PSRs), and experience contributing to global regulatory submissions and interactions with major agencies.
• Strong matrix leadership and influencing skills with cross‑functional leaders (e.g., Clinical Development, Medical Affairs, Regulatory Affairs), including representation at senior governance.
• Demonstrated people leadership: ability to lead, coach, and mentor safety physicians/scientists; excellent communication skills with the ability to present complex topics to senior leaders.
• Ability to travel domestically and internationally, as business needs require.

Desirable for the role

• PhD or other advanced degree in a relevant scientific discipline.
• Recognized subject‑matter expertise and sound independent judgment in clinical safety; disease area safety leadership experience.
• Experience speaking at industry conferences and shaping external safety messaging.
• Experience supporting in‑licensing/due diligence from a safety perspective.
• Proven ability to embed new processes/systems and drive continuous improvement in safety ways of working.

Interested? Please submit your CV by COB 10th May 2026.

Date Posted

24-Apr-2026

Closing Date

10-May-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.