Global Safety Program Lead (GSPL), Cell Therapy, Immunology

AstraZeneca • Gaithersburg, MD

1d • $288,059 - $432,089 • Hybrid

About The Position

As Senior Medical Director, Global Safety Program Lead, Cell Therapy - Immunology, you will report to the Global Safety Head of the Cell Therapy Patient Safety Unit. You will serve as the senior Patient Safety leader for assigned immunology cell therapy programs, bringing clinical judgment to benefit-risk assessment, program design, regulatory strategy, and governance. You will shape safety strategy from early development through late-stage development and, where applicable, postmarketing; lead and develop safety physicians and scientists; and help build a proactive, accountable, science-led culture within the unit.

The role provides medico-scientific and strategic safety leadership for innovative cell therapy programs across development and, where applicable, postmarketing. It covers a growing immunology cell therapy portfolio that may span multiple autoimmune indications, development stages, and therapeutic modalities. The position works across functions to shape safety strategy for high-impact assets, lead teams, optimize benefit-risk, and enable evidence-based development decisions. The company works on average at least three days per week from the office, with individual flexibility in line with local policy.

Requirements

• Medical degree or equivalent medical qualification.
• Extensive experience in clinical safety/pharmacovigilance and drug development in a pharmaceutical, biotechnology, academic, CRO, or regulatory environment.
• Demonstrated cell therapy experience, including direct involvement in clinical development and safety evaluation of cell or gene therapy programs.
• Relevant clinical or drug-development experience in immunology, rheumatology, neurology, autoimmune disease, transplantation, hematology, or another field directly applicable to autoimmune cell therapy.
• Proven track record leading asset-level safety strategy and delivery and influencing clinical study or program decisions through rigorous benefit-risk assessment.
• Deep knowledge of global pharmacovigilance regulations, GCP, safety surveillance, signal management, risk management, aggregate reporting, and safety contributions to regulatory submissions and interactions.
• Experience providing safety input to clinical trial design and execution, including dose selection, eligibility criteria, safety monitoring, stopping rules, toxicity management, and data interpretation.
• Strong matrix leadership and influencing skills, with credibility to represent Patient Safety at senior governance and cross-functional forums.
• Demonstrated people leadership, including ability to lead, coach, and mentor physicians and scientists and deliver through others.
• Excellent written and verbal communication skills, including ability to present complex and uncertain safety issues clearly to senior leaders, regulators, investigators, and external experts.
• Ability to work across multiple programs and priorities and travel domestically and internationally as business needs require.

Nice To Haves

• Board certification, specialty training, or substantial clinical experience in immunology, rheumatology, neurology, autoimmune disease, hematology, transplantation, or a related discipline.
• PhD or another advanced degree in a relevant scientific discipline.
• Experience with autologous, allogeneic, in vivo, gene-edited, or regulatory T-cell therapy platforms.
• Experience leading safety strategy across multiple autoimmune indications or across a shared asset used in more than one therapeutic area.
• Knowledge of acute and long-term cell therapy toxicities, immune reconstitution, infection risk, immunoglobulin replacement, vaccination, and antimicrobial prophylaxis.
• Basic, translational, or biomarker research experience, including peer-reviewed publications.
• Experience with global development and pharmacovigilance requirements in the US, EU, UK, China, Japan, Australia, and other major markets.
• Experience speaking at scientific or industry forums and shaping external safety communication.
• Experience supporting due diligence, business development, alliance governance, or in-licensing activities.
• Proven ability to implement new processes, systems, data approaches, and continuous-improvement initiatives in safety.

Responsibilities

• Own end-to-end safety strategy, delivery, and oversight for assigned immunology cell therapy assets and indications across preclinical, clinical, regulatory, and postmarketing stages, as applicable.
• Lead the Safety Strategy and Management Team and Safety Surveillance Team for assigned assets, setting safety objectives aligned with therapeutic-area and product strategy and ensuring high-quality, timely, and compliant delivery.
• Own scientific and clinical safety content, including the safety Target Product Profile, safety Go/No-Go criteria, toxicity management guidelines, risk minimization approaches, and internal and external safety messaging.
• Provide expert safety input to clinical development plans, study concepts and protocols, dose-escalation and expansion decisions, eligibility criteria, monitoring plans, stopping rules, long-term follow-up, and interpretation of emerging data.
• Lead proactive identification, evaluation, and management of acute and delayed cell therapy risks, including immune-mediated toxicities, infections, cytopenias, neurotoxicity, secondary malignancies, and risks associated with lymphodepletion or prolonged immune modulation, as relevant.
• Integrate clinical, translational, biomarker, epidemiology, preclinical, real-world, and literature evidence to support benefit-risk decisions across autoimmune indications and patient populations.
• Represent Global Patient Safety at product teams, governance committees, health-authority interactions, independent data-monitoring committees, advisory boards, and other forums; ensure alignment of the Patient Safety position before key decisions.
• Ensure quality and timely safety contributions to Investigator Brochures, protocols, informed consent documents, clinical study reports, DSURs, RMPs, periodic safety reports, regulatory submissions, responses to health authorities and ethics committees, and product labeling, as applicable.
• Provide strategic leadership to safety physicians and scientists, define safety-team responsibilities, delegate effectively, and ensure consistent program-level delivery across indications and studies.
• Build partnerships with Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, Medical Affairs, Clinical Operations, CMC, Epidemiology, Commercial, alliance partners, and external experts to drive proactive safety decisions.
• Use fit-for-purpose digital, data-visualization, and artificial-intelligence-enabled methods to strengthen safety surveillance, signal evaluation, knowledge integration, and decision-making while maintaining scientific and governance standards.
• Support portfolio strategy, due diligence, in-licensing, and external innovation assessments from a cell therapy safety perspective, as required.
• Line manage, coach, and develop safety physicians and/or scientists; embed effective processes and ways of working; and operate to ethical, quality, GxP, and AstraZeneca standards.

Benefits

• Short-term incentive bonus opportunity.
• Eligibility to participate in an equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Commission payment eligibility for sales roles.
• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage, subject to applicable plan terms and conditions.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree