Director, Medical Safety Assessment Physician

Bristol Myers Squibb

Lead safety assessment and benefit-risk strategies for BMS compounds as Safety Expert. Oversee safety documents, team evaluations, and regulatory support for clinical trial activities.

Posted 6/4/2026full-timePrinceton • New Jersey • 🇺🇸 United StatesLead💰 $255,860 - $310,040 per yearWebsite

About the role

Key responsibilities & impact

Lead safety activities and benefit-risk strategies for assigned BMS compounds/ program and chair the product Safety Management Team(s).
Oversee, Prepare, and/or Review aggregate safety review documents as well as safety sections of relevant clinical trial documents and regulatory filings.
Lead team in the evaluation & management of signals emerging from any data source.
Develop strategy for signal evaluation and document outcome.
Lead safety labeling activities for assigned products/ program.
Participate/ Provide input at cross-functional labeling team meetings and provide regional safety labeling support.
Lead process improvement projects.
Assist the MSA Therapeutic Area (TA) Head/Lead in developing and maintaining state-of-the-art PV processes and procedures within BMS R&D and WWPS.
Promote collegiality and teamwork among peers. Mentor/Support colleagues as a positive change agent.

Requirements

What you’ll need

MD/equivalent required.
Postgraduate qualification or experience in internal medicine, immunology, oncology, or related specialty desirable.
3+ years in PV or relevant pharmaceutical or biomedical field (eg, Medical, Clinical, Regulatory) is strongly preferred.
Understanding of the drug development process.
Knowledge of PV and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug product.
Proficient ability to leverage the range of available tools to investigate safety concerns, including the science of observational research.
Understanding of regulatory requirements for safety assessment and action.

Benefits

Comp & perks

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

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Hard Skills & Tools

safety managementsignal evaluationsafety labelingprocess improvementpharmacovigilanceclinical trial documentationregulatory filingsobservational researchdrug development processsafety assessment

Soft Skills

leadershipteamworkmentoringcommunicationcollaborationchange managementcollegialitysupportiveorganizational skillspositive change agent

Certifications

MDpostgraduate qualification in internal medicinepostgraduate qualification in immunologypostgraduate qualification in oncology