Director, Senior Patient Safety Scientist

Responsibilities

• Lead safety surveillance, signal detection, validation, evaluation and management for assigned cell therapy assets; define and document appropriate MedDRA search strategies.
• Set the safety science strategy for multiple, complex or high-priority assets and translate emerging data into clear 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; influence 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 capability across the function 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.

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; 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, with the ability to communicate 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.

Preferred Qualifications

• 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.