Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology

About the role

AstraZeneca is seeking a Global Safety Program Lead - Cell Therapy Oncology & Onco-Hematology to join the company's Global Patient Safety unit. This role involves shaping the safety strategy of high-impact cell therapy assets, providing medico-scientific and clinical strategic leadership, and advancing novel CGT technologies.

Responsibilities

• Lead the Safety Strategy & Management Team (SSaMT) and Safety Surveillance Team for assigned assets, 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.
• Ensure expert input to safety-relevant elements of study design and interpretation, including efficient use of digital/artificial intelligence (AI) tools and methodology (e.g., adverse event visualisation and disproportionality analysis).
• 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.

Requirements

• 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.

Qualifications

• PhD or other advanced degree in a relevant scientific discipline.
• Research experience in the GCT field.
• Medical specialty, or documented training, in oncology and/or haemato-oncology.
• Basic and/or Translational Research background, including authoring peer-reviewed publications.
• Good knowledge of PV regulations in China, Australia, Japan, rest of Asia.
• 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.

Skills

• Expertise in oncology and onco-hematology.
• Strong leadership and strategic planning skills.
• Excellent communication and presentation skills.
• Experience with digital and AI tools in safety assessment.

Benefits

• Retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

Pay

The annual base pay (or hourly rate of compensation) for this position ranges from $288,059.20 - $432,088.80USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours.

Schedule

3 days working from the office and 2 days working from home.