Director, Clinical Data Management

Bristol Myers Squibb • San Diego, CA

7d • Remote

About The Position

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 our patients. 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.

Requirements

• Strong knowledge and experience of EDC systems (Medidata RAVE or Veeva).
• Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required.
• Minimum of 10 years data management experience in pharmaceutical/biotech/CRO industry.
• Demonstrated experience leading study teams, vendors, or direct/indirect reports; ability to guide, mentor, and develop others as applicable.
• In-depth experience in the Oncology therapeutic area is required.
• Proven ability to manage CRO relationships and oversee data management deliverables.
• Experience utilizing AI-enabled tools to improve productivity and work efficiency.

Nice To Haves

• Radiopharmaceutical experience preferred.

Responsibilities

• Serve as the Clinical Data Management program lead for a new product and lead the individual studies within that program, providing strategic and hands-on data management leadership from study start-up through database lock.
• Develop and drive the data management strategy for the assigned new-product program, including study start-up planning, database build oversight, data review approach, risk management, database lock, and submission readiness.
• Lead data management execution at both the program and study level in partnership with study teams, ensuring high-quality, timely, and decision-ready clinical trial data across all studies within the program.
• Oversee CROs and data management vendors supporting the program and its studies, ensuring clear expectations, accountability, quality, compliance, and adherence to study and program timelines.
• Partner cross-functionally with Biostatistics, Statistical Programming, Clinical Operations, Medical Monitoring, Safety, Regulatory Affairs, and other stakeholders to align on program priorities, data quality expectations, and deliverables.
• Lead ongoing cross-functional data review activities and ensure timely identification, escalation, and resolution of data issues, trends, risks, and quality concerns.
• Oversee or contribute to key data management documentation, including Data Management Plans, edit check specifications, validation plans, reconciliation plans, data transfer agreements, data review plans, and database lock documentation.
• Willing to travel approximately 10% of the time.
• Evening and weekend work may be required.
• Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption

Benefits

• Medical, pharmacy, dental, and vision care.
• BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
• 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Associate degree