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

AstraZeneca • Gaithersburg, MD

13d • Hybrid

About The Position

This role is for a Global Safety Program Lead focusing on Cell Therapy Oncology & Onco-Hematology at AstraZeneca. The position is based in Barcelona, Spain, with a hybrid work model (3 days office, 2 days remote). The company is seeking expertise in Patient Safety within Oncology and Onco-Hematology to provide medico-scientific and clinical strategic leadership. The role involves shaping safety strategies for high-impact assets, leading cross-functional teams, and optimizing benefit-risk profiles. AstraZeneca has a broad cell therapy pipeline, offering opportunities to advance novel Cell and Gene Therapy (CGT) technologies. The company emphasizes in-person collaboration for innovation and pace, with an average of three days per week in the office, balanced with individual flexibility.

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.

Nice To Haves

• 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.

Responsibilities

• 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.
• Ensuring 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 visualization 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.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior