RayzeBio Safety MD Senior Director

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
• 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.