Director, Medical Safety Assessment Physician

Bristol Myers Squibb • Princeton, NJ

12d • $255,860 - $310,040

About The Position

The Director, Medical Safety Assessment Physician leads medical safety activities and benefit-risk strategies for assigned Bristol Myers Squibb compounds and programs, chairing product Safety Management Teams. The role oversees preparation and review of aggregate safety documents, clinical trial safety sections, regulatory submissions, safety signal evaluation and management, and safety labeling. It serves as a safety subject matter expert and global safety lead across clinical development and postmarketing, ensuring that safety work is accurate, timely, efficient, and aligned with regulatory requirements and company goals.

In clinical development, the role leads medical safety planning and execution, contributes to development plans and study documents, supports global submission documents, and develops safety risk language, risk-management strategies, integrated safety reviews, and safety-focused publications. For marketed products, it leads postmarketing safety activities, aggregate reports, risk-management strategies, signal evaluations, safety studies guidance, and labeling updates.

The position also leads process improvement, supports regulatory inspection preparation and issue management, contributes to cross-functional strategy and training, and acts as a liaison with internal and external stakeholders. It mentors colleagues and promotes collaboration within a complex matrix environment. Occasional travel is expected within the United States, approximately once every two to three months, and overseas, approximately once a year.

Requirements

• MD or equivalent required.
• At least 3 years in pharmacovigilance or a relevant pharmaceutical or biomedical field (for example, Medical, Clinical, or Regulatory) is strongly preferred.
• Understanding of the drug development process.
• Knowledge of pharmacovigilance and ability to apply it to safety concern evaluation and patient risk minimization throughout a drug product's lifecycle.
• Ability to use available tools to investigate safety concerns, including knowledge of observational research.
• Understanding of regulatory requirements for safety assessment and action.
• Strong scientific analytical reasoning skills.
• Ability to work on multiple projects in parallel.
• Excellent attention to detail.
• Behavioral competencies to work and lead within a complex matrix environment.
• Excellent verbal and written communication skills.
• Occasional travel within the United States, approximately once every two to three months, and overseas, approximately once a year.

Nice To Haves

• Postgraduate qualification or experience in internal medicine, immunology, oncology, or a related specialty.
• Relevant experience or accomplishments in clinical research, observational research, or clinical practice.

Responsibilities

• Lead safety activities and benefit-risk strategies for assigned compounds and chair product Safety Management Teams.
• Oversee, prepare, and review aggregate safety review documents and safety sections of clinical trial documents and regulatory filings.
• Lead evaluation and management of safety signals from any data source; develop evaluation strategies and document outcomes.
• Lead safety labeling activities, provide safety subject matter expertise for regulatory product labeling, and contribute to cross-functional and regional labeling activities.
• Support the EU Qualified Person for Pharmacovigilance and other regional or local Qualified Persons for Pharmacovigilance on assigned-product issues.
• Provide input to R&D publication strategy and ensure safety input to publications and presentations.
• Act as global safety lead for assigned compounds in development and provide safety-lead support for global submission document production.
• Lead medical safety development and execution of benefit-risk management strategies.
• Provide safety input to clinical development plans, protocols, amendments, investigator brochures, statistical analysis plans, informed consent forms, clinical study reports, and responses to health authority or ethics-related queries.
• Lead development of safety risk language, risk-management strategy, pre-filing safety activities, integrated safety reviews, and safety-focused publications.
• Perform medical safety reviews of development safety update reports, annual reports, and other periodic safety submissions.
• Support safety strategy preparation for pre-submission, advisory committee, scientific advice, and data monitoring committee meetings.
• Act as safety lead for assigned marketed compounds and support global postmarketing safety activities and submissions.
• Provide medical safety and benefit-risk input for aggregate reports, product renewal submissions, postmarketing study documents and reports, and responses to health authority queries.
• Lead medical safety oversight and execution of risk-management strategies and risk management plan elements.
• Prepare and review safety signal reports and ad hoc regulatory responses.
• Provide postmarketing safety study guidance to groups such as epidemiology and medical affairs.
• Ensure safety labeling reflects the emerging postmarketing safety profile.
• Lead process improvement projects and assist in developing and maintaining pharmacovigilance processes and procedures.
• Support preparation for regulatory inspections and assess processes against regulatory expectations, guidelines, and mandates.
• Assist the team and senior management with issue and crisis management.
• Liaise with therapeutic-area staff and maintain an effective, collaborative patient safety team.
• Support hiring and orientation.
• Contribute to strategic plans for safety differentiation of BMS products and prepare and provide employee training on product safety profiles and issues.
• Act as the WWPS liaison for assigned products with BMS functions, including Legal, Business Development, Operations, and Marketing.
• Support manufacturing quality and co-author integrated health hazard assessments.
• Develop communications of safety data and interpretation for internal and external audiences globally.
• Promote teamwork, mentor and support colleagues, and act as a positive change agent.

Benefits

• Comprehensive benefits, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 11 paid company holidays each year.
• For specified employee groups, 160 hours of paid vacation annually for new hires, 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree