BristolMyers Squibb

RayzeBio Safety MD Senior Director

BristolMyers Squibb$306K — $371K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • MD or equivalent degree required.
  • 10+ years of experience in pharmacovigilance or safety science in the pharmaceutical/biotech industry.
  • Strong knowledge of global pharmacovigilance regulations including FDA, EMA, and ICH.
  • Expertise in signal detection, risk management, and benefit-risk assessment.
  • Experience with global regulatory authority interactions and scientific advisory bodies.

Responsibilities

  • Lead global pharmacovigilance strategy and proactive safety surveillance.
  • Establish safety governance structures and continuous improvement processes.
  • Collaborate with cross-functional teams to integrate safety insights into product development.
  • Direct benefit-risk assessments and safety evaluations for clinical and post-marketing products.
  • Represent Safety Science in safety management committees and regulatory submissions.
  • Drive safety-related content for regulatory documents and reports.
  • Perform case reviews and ensure proper safety management throughout clinical trials.

Benefits

  • Comprehensive health coverage including medical, pharmacy, dental, and vision.
  • Well-being support programs like Employee Assistance Programs and wellness accounts.
  • Financial well-being benefits including 401(k), disability insurance, and life insurance.
  • Flexible paid time off policies allowing for unlimited vacation with manager approval.
  • Special leave benefits including paid volunteer days and additional time off for personal needs.
Full Job Description
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 If you come across a role that intrigues you but doesn’t 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. Compensation Overview: Princeton - NJ - US: $306,814 - $371,787 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 employee's 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 https://careers.bms.com/life-at-bms/. Benefit 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 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.

About BristolMyers Squibb

BristolMyers Squibb Careers

Join the vibrant team at BristolMyers Squibb, a leader in global biopharmaceutical innovation, where your career growth is as important as the life-changing solutions we develop. At BristolMyers Squibb, we are committed to fostering a diverse and inclusive workplace that encourages professional growth and development. Work You’ll Do Embark on a career with BristolMyers Squibb and be part of a company that’s dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With us, you’ll contribute to a culture that embraces scientific innovation, responsible leadership, and community outreach. Explore job opportunities in various fields from research to marketing, and join a team that values leadership and diversity. Our commitment to career growth means we support your journey with extensive training programs, leadership development opportunities, and a global, diverse network of professionals. Innovative Work At BristolMyers Squibb, innovation is at the core of everything we do. From pioneering research in oncology to breakthroughs in immunology, our professionals have the opportunity to make significant contributions to the field and impact lives globally. Our collaborative environment encourages team members to challenge the status quo and bring forward ideas that pave the way for groundbreaking solutions. Be Part of a Great Team Working at BristolMyers Squibb means being part of a team that supports your aspirations and shares your values. Our culture thrives on teamwork, respect, and diversity, creating a workplace where everyone can achieve their potential. Enjoy the benefits of being part of a company that values work-life balance, provides competitive benefits, and fosters an environment where skills and leadership are developed through hands-on experience and comprehensive mentorship programs. Future-Proof Your Career With a multitude of job opportunities ranging from internships to full-time positions, BristolMyers Squibb is not just hiring; we’re building futures. We equip our employees with the tools needed for success, including advanced training in diverse skill sets, leadership programs, and opportunities for professional networking and growth. Stay Connected Join Our Team Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference. Explore our career portal for all current job listings and be sure to submit your resume. Keep Up to Date Stay informed with the latest company news, career tips, and industry insights from BristolMyers Squibb. Our careers blog is a resource for potential and current employees looking to maximize their career potential. Job Alert Emails Customize your subscription to receive job alerts and insider information tailored to your preferences. Discover the exciting and rewarding career opportunities that await at BristolMyers Squibb. At BristolMyers Squibb, your career is just the beginning – it’s a pathway to personal and professional fulfillment. Join us and make a global impact.
Learn more about BristolMyers Squibb
Size
32,200 employees
Market Cap
$156.3 billion
Industry
Net Income
-$9 billion
Founded
1887
5 Year Trend
+19%
Revenue
$42.5 billion
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