Director, Clinical Data Management

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. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

Director, Head of Clinical Data Management

Summary:

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

The Director, Clinical Data Management, will lead the Data Management function at RayzeBio, providing both strategic leadership and hands-on operational oversight across the clinical portfolio. Reporting to the Head of Biometrics, this role is responsible for ensuring the accuracy, integrity, consistency, and regulatory readiness of clinical trial data from study start-up through NDA/BLA submission.

The ideal candidate combines strong technical, operational, and leadership expertise with the ability to build scalable processes, oversee CROs and vendors, drive cross-functional collaboration, and proactively resolve complex data challenges in a fast-paced development environment.

Job Responsibilities:

• 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.

Skills and Knowledge:

• 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.

Basic 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.

Preferred Requirements:

• Experience with Veeva