Bristol Myers Squibb
RayzeBio Safety MD Senior Director
Princeton Pike - NJ, USA · Director · Full-time
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About the role
- The starting pay range(s) listed above is for full-time employees (FTE).
- You may also be eligible for additional discretionary incentive cash and stock opportunities.
Responsibilities
- Lead or co-lead global pharmacovigilance strategy, proactive safety surveillance, signal detection, risk management, and compliance with FDA, EMA, ICH, and other applicable regulations.
- Establish and maintain safety governance structures, SOPs, and continuous improvement processes aligned with company objectives and industry best practices.
- Drive safety-related content for protocols, investigator brochures, DSURs, PSURs, RMPs, ICFs, RSLs, CSRs, regulatory filings, and responses to regulatory inquiries.
- Perform daily ICSR/SAE case reviews and support appropriate safety management across all phases of clinical trials.
- BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Requirements
- 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry.
- Experience interacting with global regulatory authorities and scientific advisory bodies
- If this posting is missing required information required by local law or incorrect, contact BMS at TAEnablement@bms.com with the Job Title and Requisition number.
Nice to have
- Radiopharmaceutical experience
- Oncology Safety experience
- NDA/MAA/JNDA submission experience
- Skills and Qualifications
- We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
- Compensation Overview:
- Princeton - NJ - US: $306,814 - $371,787
- Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Skills
- Strong leadership and communication skills
- Proven ability to work effectively in a matrixed, cross-functional environment.
- Demonstrated commitment to patient safety and ethics in medical practice.
- 25% travel
Compensation
- The starting pay range(s) listed above is for full-time employees (FTE).
- Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
Benefits
- U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
- Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
- U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
- Partner with BMS safety, clinical development, regulatory, medical affairs, and cross-functional teams to integrate safety insights into product development, clinical trials, labeling, and risk minimization strategies.
- Direct safety evaluation and benefit-risk assessment for clinical development and post-marketing products, including AE profile management and product safety strategy.
- Represent Safety Science as lead or co-lead Safety MD in Safety Management Teams/Committees, study team meetings, health authority interactions, regulatory submissions, periodic safety reports, audits, and inspections.
Company info
- Here, you'll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.
- If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
- Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.
Equal opportunity
- Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
- Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
This listing is sourced directly from Bristol Myers Squibb's careers page and normalized into a canonical job model.