Associate Director, Patient Safety Scientist

AstraZeneca•Gaithersburg, MD

23h•Hybrid

About The Position

The Associate Director, Cell Therapy Patient Safety Scientist is an experienced safety scientist within the Cell Therapy Patient Safety Unit, Global Patient Safety. The role leads defined safety-science activities for assigned cell therapy assets, working with the Global Safety Program Lead, Patient Safety Physicians, and cross-functional partners. It integrates safety data from multiple sources, supports benefit-risk decisions, delivers safety documentation, and helps manage patient risks across the product lifecycle. The position conducts safety surveillance, signal detection and management; contributes to pharmacovigilance and risk-management planning; authors aggregate reports and safety content for clinical and regulatory documents; supports submissions, inspections, and regulatory interactions; and contributes to governance and cross-functional teams. It also provides guidance to junior colleagues, contributes to process improvements, and applies approved AI tools to safety workflows with appropriate human oversight, validation, traceability, confidentiality, and output verification. The role is on-site three days per week and work from home two days per week. Duties are generally conducted in an office environment, with general availability during standard business hours. The annual base pay ranges from $132,000 to $199,000. The role is eligible for short-term incentive bonuses and equity-based awards, and benefits include qualified retirement programs, paid time off, and health, dental, and vision coverage.

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related discipline with relevant experience, or an advanced degree with relevant experience.
Substantial pharmaceutical, biotechnology, or CRO experience in patient safety/pharmacovigilance and drug development, including experience independently delivering safety-science activities.
Experience in at least three of the following: clinical development safety; signal management; periodic safety reports; risk-management plans; safety sections of protocols, IBs, ICFs, or CSRs; regulatory responses; governance support.
Good knowledge of US, EU, and UK pharmacovigilance regulations and ICH guidelines.
Experience with benefit-risk assessment, safety databases, MedDRA coding/search strategies, and interpretation of data from multiple sources.
Strong analytical, problem-solving, project-management, scientific-writing, and communication skills, with the ability to work effectively in a global matrix.
Practical experience using large language models and agentic AI tools for scientific or safety work, including prompt/agent design, workflow automation, human oversight, validation, traceability, data privacy, and critical verification of outputs.
Fluent written and verbal English.

Nice To Haves

MSc, PhD, PharmD, or equivalent advanced degree in immunology, autoimmune disease, pharmacology, or a related discipline.
Experience in immunology research or drug development and in cell and gene therapy product development.
Experience with clinical and safety databases, pharmacoepidemiology, real-world evidence, or quantitative safety methods.
Experience supporting regulatory submissions, inspections, or health-authority responses.
Experience configuring or evaluating an agentic AI workflow in a regulated scientific environment.
Knowledge of pharmacovigilance regulations beyond the US, EU, and UK.

Responsibilities

Conduct and coordinate safety surveillance, signal detection, validation, evaluation, and management for assigned cell therapy assets; develop MedDRA search strategies with appropriate guidance.
Translate emerging safety data into clear analyses and recommendations for asset teams, escalating complex or high-impact issues to the Global Safety Program Lead and Patient Safety Physician.
Lead defined components of pharmacovigilance and risk-management planning, including RMPs, REMS, risk-minimization tracking, and benefit-risk assessments.
Author and project-manage aggregate reports and safety deliverables, including DSURs, PBRERs/PSURs, PADERs, RMPs, REMS, and ad hoc analyses.
Author and coordinate safety content for protocols, Investigator Brochures, Reference Safety Information, informed consent forms, clinical study reports, Data Monitoring Committee materials, and core data sheets.
Support safety contributions to submissions and health-authority responses, including NDA/BLA and MAA packages, and participate in inspections and regulatory interactions as assigned.
Coordinate and contribute to SSaMT/Safety Surveillance Team activities, prepare governance materials, and present analyses to SIRC or other governance bodies as appropriate.
Represent the Cell Therapy Patient Safety Unit on program and cross-functional teams, ensuring agreed safety actions are documented and delivered.
Contribute safety expertise to third-party agreements and partnerships, supporting clear accountabilities and compliant safety processes.
Provide day-to-day guidance, training, and coaching to junior safety scientists, fellows, and colleagues in relevant safety processes.
Contribute to process improvements, standard procedures, templates, and quality-control practices for safety analytics and reporting.
Apply agentic AI and other AI tools to approved safety workflows, including literature and data synthesis, document-authoring support, and workflow automation, while maintaining human oversight, validation, traceability, confidentiality, and output verification.
Partner with digital and data-science colleagues to test, document, and improve approved agentic AI workflows and reusable prompts/agents.
Support additional Patient Safety priorities as directed by the line manager.