Senior Medical Director, Patient Safety

Be among the first 25 applicants Senior Medical Director, Patient Safety Providing growth phase Biotech & Pharma companies access to leading talent across Clinical, Patient Safety & Medical Affairs A pioneering, values-driven biotechnology organisation developing next-generation precision genetic medicines is seeking an experienced Senior Medical Director, Patient Safety to help shape and lead safety strategy across a cutting-edge portfolio. This is an opportunity to play a pivotal role in patient safety for transformative therapies in serious and life-limiting diseases, including advanced gene and cell therapy programmes. The Opportunity As Senior Medical Director, Patient Safety, you will provide clinical, scientific and safety leadership across the full lifecycle of innovative therapies. You will drive benefit-risk strategy, safety surveillance, signal detection, regulatory engagement, and PV governance- while contributing to the build-out and continued evolution of the organisation’s global PV function. You’ll partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Quality and senior leadership, and act as a key safety representative in health authority interactions. This role is ideal for a senior physician-leader excited by complex science, robust safety governance, and the chance to shape safety strategy for ground-breaking genetic medicines. Must have Requirements At least 5 years in Patient Safety/Safety Science, including leading Signal detection & risk management activities on Clinical Development projects 3 years in Gene Therapy or Cell Therapy safety Be located within 3 hours of Cambridge (remote role but client wants team close enough for ad hoc face to face meetings) Key Responsibilities Strategic Safety Leadership Lead global patient safety and PV risk-management activities across a diverse portfolio. Drive benefit-risk strategy, safety surveillance, and signal detection using clinical, non-clinical, post-marketing and literature sources. Chair or co-lead multidisciplinary committees focused on safety governance and regulatory decision-making. Regulatory & Safety Governance Act as PV Subject Matter Expert in interactions with global Health Authorities. Lead or support the authoring of DSURs, PSURs/PBRERs, PADERs, IND annual reports, safety sections of BLA/NDA filings and labeling. Oversee development and maintenance of core safety documents including CCDS, CCSI, IB and RSI. Operational Excellence Conduct ICSR medical review, AOSE assessments and ensure high-quality medical oversight of case management activities. Support inspection readiness, audits, vendor oversight and PV system governance. Contribute to SOPs, Safety Management Plans, training materials and process optimisation. Cross-Functional Partnership Collaborate on REMS/RMP development, safety mitigation strategies and study design activities. Provide PV expertise throughout clinical development, study execution and post-marketing safety. Support organisational leadership, team development, mentorship and recruitment within PV. Qualifications MD required; board certification strongly preferred. 15+ years total experience, including 5+ years in Pharmacovigilance. Experience in gene or cell therapy, oncology, rare disease or other severe indications strongly preferred. Proven leadership as a Global Safety Lead or equivalent, with responsibility for major PV deliverables. Strong knowledge of FDA, EMA and ICH PV regulations, and hands-on experience supporting regulatory interactions. Proficiency with PV databases (e.g., ARGUS, ARISg) and MedDRA. Demonstrated ability to interpret complex safety data, drive risk-mitigation strategy, and influence cross-functional stakeholders. Thrives in a fast-paced, evolving biotech environment with multiple priorities. Outstanding communication, leadership, organisational and strategic decision-making skills. Why This Role? Shape safety strategy in one of the most innovative areas of biotechnology. Influence high-impact therapies with the potential for lifelong patient benefit. Join a mission-driven organisation committed to science, patients and excellence. Lead within a growing, modern PV function with senior visibility and strategic influence. Seniority level Mid-Senior level Employment type Full-time Job function Research Biotechnology Research and Pharmaceutical Manufacturing Inferred benefits Medical insurance Vision insurance 401(k) #J-18808-Ljbffr