Note: The job is a remote job and is open to candidates in USA. RayzeBio, a subsidiary of Bristol Myers Squibb, is a biotechnology company focused on developing transformative radiopharmaceutical therapies for cancer patients. The Director, Clinical Data Management will lead the data management strategy and execution for a new product, ensuring high-quality and timely clinical trial data while collaborating with various internal and external stakeholders.
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
Skills
- 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
- 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
- Radiopharmaceutical experience preferred
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Programs such as 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
- Survivor support.
- 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
- 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.
- 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.
- Willing to travel approximately 10% of the time. Evening and weekend work may be required.
Company Overview
Company H1B Sponsorship