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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about 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 organizations 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

BASIC QUALIFICATIONS:

• MD or equivalent (MBBS etc)
• 10 years of experience in pharmacovigilance safety science or related area within the pharmaceutical/biotechnology industry.
• 10 years of experience in pharmacovigilance safety science or related area within the pharmaceutical/biotechnology industry.
• Full knowledge/awareness of existing/current global pharmacovigilance regulations and guidelines including FDA EMA and ICH
• Demonstrable understanding of clinical development post-marketing safety and regulatory submissions
• Demonstrated expertise in signal detection risk management benefit-risk assessment and aggregate safety reporting.
• Experience interacting with global regulatory authorities and scientific advisory bodies
• NDA/MAA/JNDA submission experience preferably

PREFERRED QUALIFICATIONS

• Radiopharmaceutical experience
• Oncology 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.
• Demonstrated commitment to patient safety and ethics in medical practice.

WORK ENVIRONMENT

• Demonstrated commitment to patient safety and ethics in medical practice.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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.

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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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: Protection

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