Senior Director, Clinical Data Management

Bristol Myers SquibbSan Diego, CA
$261,110 - $316,404Onsite

About The Position

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.

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 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.

Nice To Haves

  • Experience with Veeva EDC system
  • Radiopharmaceutical experience preferred.

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

Benefits

  • 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.
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