Associate Director, Medical Safety Assessment Physician, Cell Therapy in London

Associate Director, Medical Safety Assessment Physician, Cell Therapy

This role is part of the Worldwide Patient Safety (WWPS) group, responsible for ensuring the safety of Bristol Myers Squibb medicines.

Responsibilities

• General Product Support
• Support safety activities and benefit‑risk strategies for assigned BMS compounds.
• Prepare aggregate safety review documents such as DSURs and PBRERs, and safety sections of clinical trial documents (protocols, CSRs, IBs, ICFs).
• Evaluate and manage signals from any data source, documenting outcomes in Safety Topic Reviews or Signal Reports.
• Support safety labeling activities and provide safety input for regulatory product labeling.
• Participate in cross‑functional labeling team meetings and provide regional safety labeling support.
• Support the EU QPPV or other regional Qualified Person for PV on safety issues.
• Support R&D publication strategy and ensure safety input to publications and presentations.
• Clinical Development Support
• Act as the global safety lead for assigned compounds in development.
• Provide safety lead support for global submission document production.
• Contribute safety input to clinical development plans, protocols, and other regulatory documents.
• Support risk management strategy, safety table shells, integrated safety data reviews, and safety-focused publication development.
• Perform medical safety review of periodic safety submissions.
• Support safety strategy preparation for pre‑submission, advisory committee, and scientific advice meetings.
• Postmarketing Support
• Support the global safety lead for marketed compounds and global postmarketing safety activities.
• Provide medical safety and benefit‑risk input for safety aggregate reports and product renewal submissions.
• Oversee risk management strategies and RMP elements, and evaluate safety signals.
• Prepare Safety Topic Review/Signal Reports and ad‑hoc regulatory responses.
• Ensure safety labeling reflects the emerging postmarketing safety profile.
• Department Activities
• Prepare for regulatory inspections, evaluate current processes, and assess alignment with regulatory expectations.
• Assist in issue management and crisis management initiatives.
• Cross‑Functional Activities
• Support manufacturing quality and co‑author integrated health hazard assessments.
• Develop safety data communications and interpretation for global stakeholders.

Qualifications

• MD or equivalent required.
• Postgraduate qualification or experience in internal medicine, immunology, oncology, or a related specialty desirable.
• Experience in clinical research, observational research, or clinical practice considered an asset.
• Strong scientific analytical reasoning skills.
• Ability to manage multiple projects concurrently.
• Excellent attention to detail.
• Strong verbal and written communication skills.
• Experience working and leading in a complex matrix environment.
• Travel

Occasional domestic and international travel required, approximately once every three months, with overseas travel once per year.

Benefits

We offer a wide variety of competitive benefits, services, and programs to support employees in their professional and personal goals.

Equal Employment Opportunity

Visit careers. bms. com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws.

Disability Accessibility

BMS is Disability Confident – Employer.

Data Protection

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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