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 benefitrisk and maintain competitive advantage across development and postmarketing.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 endtoend safety strategy delivery and oversight of assigned asset(s) across preclinical clinical and postmarketing. 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 highquality compliant delivery of safety activities.
• Own the scientific and clinical safety content for the asset(s) including safety TPP safety Go/NoGo criteria toxicity management guidelines and safety messaging integrating inputs from clinical epidemiology preclinical 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 postmarketing surveillance to inform labeling and risk minimization.
• Build and maintain strong internal and external networks including alliance partners to drive proactive crossfunctional solutionoriented safety actions; may support due diligence and inlicensing 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 postlaunch.
• Proven track record of leading asset safety strategy and delivery with demonstrated strategic influence on clinical studies/programs and benefitrisk 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 crossfunctional 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 subjectmatter 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 inlicensing/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

Closing Date