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

AstraZeneca • Gaithersburg, MD

8d • $288,059 - $432,089 • Hybrid

About The Position

AstraZeneca is seeking a Global Safety Program Lead for Cell Therapy Oncology & Onco-Hematology. This role involves providing medico-scientific and clinical strategic leadership within Global Patient Safety, focusing on shaping the safety strategy of high-impact assets and leading cross-functional teams to optimize benefit-risk. The position offers the opportunity to work with a broad cell therapy pipeline, advancing novel Cell and Gene Therapy (CGT) technologies. The role emphasizes in-person collaboration to foster innovation and teamwork, with a minimum 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 or clinical development 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.
• Strong experience and knowledge of Gene & Cell therapy
• 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 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.

Benefits

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

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