Drug Safety Physician

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/

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals

RayzeBio Safety MD

Summary/Job Purpose:

Safety MD lead/co-lead roles/responsibilities on proactive safety surveillance/monitoring of safety signals/risks/issues and providing safety/PV expertise including mentoring in interactions with cross-functional groups.  

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Safety lead/co-lead contribution to the global pharmacovigilance strategy to ensure proactive safety risk and surveillance, safety management and compliance with local and international PV regulations (e.g., FDA, EMA, ICH).
• Safety lead/co-lead contribution in establishing and maintaining robust safety governance structures and standard operating procedures, ensuring alignment with company objectives and industry best practices.
• Ensure collaboration with BMS safety and clinical development leadership Safety Science and Risk Management
• Direct safety evaluation and risk management for clinical development and post-marketing products, including benefit-risk assessments and product safety strategy.
• Provide safety lead/co-lead representation via the Safety Management Team/Safety Management Committee in the proactive detection, evaluation, management and of safety signals/risks, collaborating with cross functional teams to implement risk minimization strategies and communicate potential safety concerns including important new safety information/finding as well as those meeting criteria for unanticipated problem (UAP).
• Represent safety science as lead/co-lead safety MD for health authority interactions and drive safety related content of regulatory submissions, periodic safety reports (e.g., DSURs, PSURs, RMPs), and responses to regulatory inquiries.
• Contribute to understanding and managing the AE profile of products in development and ensuring appropriate safety management in all phases of clinical trials
• Lead the strategy and review of safety modules and risk management plans in regulatory filings
• Mentoring cross functional colleagues, direct reports, safety colleagues on PV key concepts/principles
• Performing daily ICSR/SAE case reviews through existing SAE safety databases.
• Contribute to the development of risk/benefit analyses in regulatory filings and HTA submissions
• Cross-Functional Leadership and Stakeholder Engagement Partner with clinical, regulatory, and medical affairs teams to integrate safety insights into product development, clinical trial design, and labeling strategies.
• Providing safety lead/co lead contribution to safety sections of documents during protocol reviews, IB and DSUR updates, ICFs or Reference Safety Language (RSLs), CSRs, etc.
• Actively participate in Data Review Meetings/Activities on the RYZ Investigational Products.
• Active participation as safety lead MD in study team meetings (SET meetings) for the respective RYZ project teams, safety knowledge group consultations, etc.
• Act as the key PV representative for interactions with global regulatory authorities and stakeholders, advocating for patient safety
• Engage with external experts, scientific bodies, and industry groups to stay updated on evolving PV practices and enhance the organization’s safety profile.
• Providing safety MD lead support/co-lead in Regulatory Agencies’ PV audits, FDA GPV or GCP inspections, etc
• Define and implement processes for continuous improvement within safety science, and risk management.
• Back up Safety MD for PV Head