RayzeBio Safety MD Senior Director

Bristol-Myers Squibb Company; New Jersey; On-site; USD 307,000 - 372,000; Full time

Benefits offered by this job

Flexible Time Off

11 holidays per year

Vacation time

Job summary

RayzeBio, a wholly‑owned subsidiary of Bristol Myers Squibb, seeks a Safety MD to lead global pharmacovigilance across clinical development and post‑marketing activities from its New Jersey operations.

You will drive proactive safety surveillance, signal detection, risk management, and benefit‑risk assessment, mentor cross‑functional teams, and collaborate with regulatory authorities to ensure patient safety.

Qualifications

• MD or equivalent degree.
• 10+ years pharmacovigilance experience.
• Experience with FDA, EMA, ICH regulations.
• Radiopharmaceutical/oncology safety experience preferred.

Responsibilities

• Lead global pharmacovigilance strategy and proactive safety surveillance.
• Establish safety governance structures and SOPs.
• Partner with safety, clinical development, regulatory, medical affairs, and cross‑functional teams to integrate safety insights.
• Direct safety evaluation and benefit‑risk assessment for clinical and post‑marketing products.
• Represent Safety Science as lead or co‑lead in Safety Management Teams/Committees and regulatory interactions.
• Drive safety‑related content for protocols, DSURs, PSURs, RMPs, CSRs, and regulatory responses.
• Perform daily ICSR/SAE case reviews across all trial phases.
• Mentor cross‑functional colleagues on PV concepts and practices.
• Leverage AI to improve program performance and outcomes.

Skills

Leadership

Communication

Cross-functional collaboration

Patient safety

Travel

Education

MD or equivalent

Job description

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly‑owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. 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. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

Learn more about RayzeBio: https://careers.bms.com/rayzebio/

The Safety MD role for RayzeBio will provide medical safety leadership across clinical development and pharmacovigilance activities, with a strong focus on proactive safety surveillance, signal detection, risk management, and benefit‑risk assessment. The role will partner closely with clinical, regulatory, medical affairs, and safety teams to support product development, regulatory submissions, health authority interactions, and safety governance. This individual will serve as a key safety representative for RayzeBio/BMS programs, mentor cross‑functional colleagues, and help strengthen safety science processes and patient safety practices.

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.
• 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.
• 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.
• Serve as a key PV representative for global regulatory authorities, external experts, scientific bodies, and industry groups while advocating for patient safety.
• Mentor cross‑functional colleagues, direct reports, and safety team members on core PV concepts and practices.
• Leverage AI to improve program, portfolio, or functional performance through prioritization and scaled adoption.
• Serve as backup Safety MD for the PV Head as needed.

Basic Qualifications

• MD or equivalent
• 10+ years of experience in pharmacovigilance, safety science, or related area within the pharmaceutical/biotechnology industry.
• Demonstrated knowledge/awareness of existing/current global pharmacovigilance regulations and guidelines, including FDA, EMA, and ICH
• Demonstrated expertise in signal detection, risk management, benefit‑risk assessment, and aggregate safety reporting.
• Experience interacting with global regulatory authorities and scientific advisory bodies

Preferred Qualifications

• Radiopharmaceutical experience
• Oncology Safety experience
• NDA/MAA/JNDA submission experience

Skills and Qualifications

• 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 Overview

• Princeton - NJ - US: $306,814 - $371,787

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. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. 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.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• 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.
• Depending on eligibility, employees may also have access to additional time‑off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between ChristmasDay and NewYear'sDay.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly‑owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

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

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application‑related inquiries to this email. To check your application status, please login to your Candidate Home Account.