Do you bring expertise in patient safety, clinical development, and cell therapy, together with a passion for improving outcomes in immune-mediated and autoimmune diseases? This is an opportunity to provide medico-scientific and strategic safety leadership for innovative cell therapy programs across development and, where applicable, postmarketing.

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. Within Global Patient Safety, you will shape safety strategy for high-impact cell therapy assets, lead cross-functional teams, optimize benefit-risk, and enable evidence-based development decisions. You will work across a growing immunology cell therapy portfolio that may span multiple autoimmune indications, stages of development, and therapeutic modalities.

In-person collaboration helps us connect, work at pace, and challenge established thinking. We therefore work, on average, a minimum of three days per week from the office, while respecting individual flexibility in line with local policy.

The role

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 and bring deep clinical judgement 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, and science-led culture within the unit.

Accountabilities

· Own the end-to-end safety strategy, delivery, and oversight for assigned immunology cell therapy asset(s) and indications across preclinical, clinical, regulatory, and postmarketing stages, as applicable.

· Lead the Safety Strategy and Management Team and Safety Surveillance Team for assigned asset(s), setting clear safety objectives aligned with therapeutic-area and product strategy and ensuring high-quality, timely, and compliant delivery.

· Own the scientific and clinical safety content for assigned programs, 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 to the program.

· Integrate clinical, translational, biomarker, epidemiology, preclinical, real-world, and literature evidence to support benefit-risk decisions across multiple 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 internal or external forums; ensure clear alignment of the Patient Safety position before key decisions.

· Ensure the quality and timely delivery of 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 responsibilities across the safety team, delegate effectively, and ensure consistent program-level delivery across indications and studies.

· Build strong partnerships with Clinical Development, Translational Medicine, Biometrics, Regulatory Affairs, Medical Affairs, Clinical Operations, CMC, Epidemiology, Commercial, alliance partners, and external experts to drive proactive and solution-oriented 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 appropriate 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 the highest ethical, quality, GxP, and AstraZeneca standards.

Essential for the role

· Medical degree or equivalent medical qualification.

· Extensive experience in clinical safety/pharmacovigilance and drug development across the pharmaceutical, biotechnology, academic, CRO, or regulatory environment.

· Demonstrated cell therapy experience, including direct involvement in the 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 of 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 the credibility to represent Patient Safety at senior governance and cross-functional forums.

· Demonstrated people leadership, including the ability to lead, coach, and mentor physicians and scientists and to deliver through others.

· Excellent written and verbal communication skills, including the 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 to travel domestically and internationally as business needs require.

Desirable for the role

· 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.

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. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

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