Director, Senior Patient Safety Scientist

AstraZeneca•Gaithersburg, MD

About The Position

The Director, Cell Therapy Patient Safety Scientist is a senior scientific leader within the Cell Therapy Patient Safety Unit, Global Patient Safety (GPS). The role leads safety science strategy and delivery for multiple and/or complex cell therapy assets, working with the Global Safety Program Lead (GSPL), Patient Safety Physicians, and cross-functional partners. The Director integrates clinical, nonclinical, epidemiologic, and real-world evidence to shape safety profiles, guide benefit-risk decisions, support governance and regulatory interactions, and protect patients across the product lifecycle. The role provides strategic leadership for safety surveillance, signal management, pharmacovigilance and risk management, aggregate safety reporting, safety content in development documents, major regulatory submissions, and health-authority interactions. It represents Patient Safety on global program teams and governance forums, mentors safety scientists, advances functional standards, and oversees responsible use of agentic AI in safety workflows in partnership with digital, data science, clinical, and regulatory colleagues. The duties are generally conducted in an office environment. Employees must be able, with or without reasonable accommodation, to use a computer; communicate by phone, video, and electronic messaging; engage in analysis, problem-solving, and dialogue; collaborate with others; and maintain general availability during standard business hours.

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related discipline with substantial relevant experience, or an advanced degree with relevant experience.
Extensive pharmaceutical, biotechnology, or CRO experience in patient safety/pharmacovigilance and drug development, including leadership of complex safety or scientific activities.
Proven experience setting program-level safety strategy and leading at least three of the following: early/late clinical development; NDA/BLA or MAA submissions; periodic safety reports; risk-management plans; signal management; governance interactions; health-authority responses.
Strong knowledge of US, EU, and UK pharmacovigilance regulations and ICH guidelines, with the ability to interpret evolving requirements and define an organizational response.
Demonstrated leadership in benefit-risk assessment, scientific communication, matrix influence, decision-making under uncertainty, and management of multiple priorities.
Advanced scientific writing and presentation skills, including communicating complex safety issues to senior governance bodies and external stakeholders.
Hands-on expertise designing or overseeing agentic AI workflows using large language models and related tools, with knowledge of responsible AI, human-in-the-loop oversight, validation, traceability, data privacy, and regulated-quality expectations.
Fluent written and verbal English.

Nice To Haves

MSc, PhD, PharmD, or equivalent advanced degree in immunology, autoimmune disease, pharmacology, epidemiology, or a related discipline.
Expertise in cell therapy safety, including proactive identification, characterization, monitoring, and mitigation of key cell therapy risks.
Deep experience in immunology cell therapy development, peri-submission and/or post-marketing safety.
Experience with pharmacoepidemiology, real-world evidence, quantitative safety methods, or predictive safety analytics.
Experience leading regulatory inspections or health-authority interactions and influencing senior governance decisions.
Experience deploying governed agentic AI solutions in a GxP or similarly regulated environment, including evaluation frameworks, auditability, and change control.
Knowledge of pharmacovigilance regulations in China, Japan, Australia, and other regions.

Responsibilities

Lead safety surveillance, signal detection, validation, evaluation, and management for assigned cell therapy assets, and define and document appropriate MedDRA search strategies.
Set safety science strategy for multiple, complex, or high-priority assets and translate emerging data into recommendations for governance and development teams.
Lead proactive pharmacovigilance and risk-management planning, including Global Risk Management Plans, REMS, risk-minimization measures, and benefit-risk assessments.
Provide strategic leadership and oversight for aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS, and ad hoc analyses.
Lead safety content and strategy for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials, and core data sheets.
Lead safety contributions to major submissions and health-authority responses, including NDA/BLA and MAA packages, and represent Patient Safety in inspections and complex regulatory interactions.
Chair or lead safety forums and cross-functional discussions, including SSaMT/Safety Surveillance Team activities and presentations to SIRC or other governance bodies.
Serve as a senior Patient Safety representative on global program and cross-functional teams, influencing development strategy through scientifically grounded, patient-focused recommendations.
Lead or advise on safety provisions in third-party agreements and partnerships, ensuring scientific quality, clear accountabilities, and regulatory compliance.
Mentor safety scientists, build functional capability, and provide expert training in cell therapy safety, pharmacovigilance methods, and benefit-risk assessment.
Sponsor process improvements and functional standards for safety analytics, reporting, governance, and regulatory readiness.
Define and oversee responsible use of agentic AI in safety workflows, including use-case selection, human-in-the-loop controls, validation, traceability, data protection, output verification, and benefit realization.
Partner with digital, data science, clinical, and regulatory colleagues to scale validated agentic AI solutions and establish fit-for-purpose governance and performance measures.
Support additional Patient Safety priorities as directed by the line manager.