RayzeBio Safety MD Senior Director

Bristol Myers Squibb • Princeton, NJ

4d • $306,814 - $371,787 • Onsite

About The Position

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.

Requirements

• 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
• 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.

Nice To Haves

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

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.

Benefits

• 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.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior