Associate Director, Patient Safety Scientist
About The Position
The Associate Director, Cell Therapy Patient Safety Scientist is an experienced safety scientist in the Cell Therapy Patient Safety Unit, Global Patient Safety (GPS). The role leads defined safety-science activities for assigned cell therapy assets in partnership with the Global Safety Program Lead (GSPL), Patient Safety Physicians, and cross-functional colleagues. It integrates safety data from multiple sources, supports benefit-risk decisions, produces high-quality safety documentation, and helps manage patient risks across the product lifecycle. The role also represents the Patient Safety Unit on program and cross-functional teams, provides guidance and coaching to junior colleagues, and contributes to improvements in safety processes and reporting. It applies approved agentic AI and other AI tools to safety workflows while maintaining human oversight, validation, traceability, confidentiality, and verification of outputs. The position is generally conducted in an office environment and follows an arrangement of three days in the office and two days working from home.
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 areas: 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 and 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 GSPL 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 or agents.
- Support additional Patient Safety priorities as directed by the line manager.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
