Senior Director, Clinical Data Management

About the Role

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.

The Senior Director, Head of Data Management, will lead data management activities for clinical development. This role is critical in establishing and managing data management strategy, ensuring high-quality database build, data integrity, and inspection readiness to support pivotal studies and regulatory submissions. The Senior Director will provide leadership across studies and programs, collaborating cross-functionally to ensure aligned data strategies, while driving efficiencies through process standardization, SOP development, vendor oversight, and implementation of automation and advanced technologies.

Responsibilities

• Lead and oversee data management activities across the clinical portfolio, ensuring high-quality, timely, and compliant data deliverables for all studies
• Provide strategic leadership for data management in support of NDA submissions, including database lock, submission readiness, and regulatory inspection preparedness
• Build, lead, and develop the data management team, including hiring, performance management, and capability development
• Serve as the primary interface with external partners to ensure alignment on data standards, processes and resource planning
• Oversee vendor strategy and performance across all studies, including selection, budget management, timeline oversight, and quality assurance
• Drive standardization of data management processes and lead development and implementation of SOPs to support scalable and inspection-ready operations
• Establish and maintain efficient database build, data cleaning, and data review processes across studies, ensuring consistency and quality
• Lead database strategy, including build, validation, and lock processes across studies, ensuring timely and high-quality delivery
• Partner cross-functionally with Clinical Operations, Clinical Development, Biostatistics, and Safety to ensure alignment on study execution and data quality

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Mathematics, Health Sciences, or a related field required
• Minimum of 12 years data management experience in pharmaceutical/biotech/CRO industry
• Demonstrated experience in team leadership and management. Ability to guide, mentor, and develop team members
• 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

Skills

• 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

Preferred Qualifications

• Experience with Veeva EDC system
• Radiopharmaceutical experience preferred

Pay

Remote - United States - US: $241,768 - $292,966. 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.

Benefits

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:
  • 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.

Schedule

Remote position. Eligibility for 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.

This response is AI-generated, for reference only.