Director, Clinical Data Management

Role Overview

• Lead the Clinical Data Management function at RayzeBio, providing strategic and operational oversight across the clinical portfolio.
• Serve as the Data Management lead for a high-priority clinical development program, maintaining hands-on involvement in study execution, data review, issue resolution, and risk management.
• Provide leadership for NDA/BLA submission activities, including submission readiness, data standards compliance, and regulatory inspection preparedness.
• Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Safety, and Regulatory Affairs to support study execution and data quality objectives.
• Oversee CROs and vendors, ensuring quality, compliance, accountability, and adherence to timelines and deliverables.
• Lead ongoing cross-functional data review activities and oversee development of key data management documentation, including Data Management Plans, edit checks, validation specifications, reconciliation plans, and data transfer agreements.
• Develop and implement scalable data management processes, standards, governance, and SOPs to support operational excellence and organizational growth.
• Manage competing priorities across multiple studies while proactively identifying operational risks and mitigation strategies.
• Build, develop, and expand the Clinical Data Management team, and foster a collaborative and high-performing team environment.
• Willing to travel approximately 10% of the time. Evening and weekend work will be involved.

Requirements

• 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 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.

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