Director, Clinical Data Management

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

We are seeking a highly motivated Director of Clinical Data Management (CDM) to lead study-level data management activities in support of our oncology clinical development programs. This individual will serve as the compound CDM lead for one or more clinical trials, responsible for the planning, execution, and oversight of data management activities in collaboration with internal stakeholders, including US/ex-US DM team and external partners (e.g., CROs, technology vendors).

This is an exceptional opportunity to contribute directly to the success of high-impact oncology trials in a dynamic and collaborative environment. The role will report to the Head of Clinical Data Management and may evolve to include line management responsibilities as the organization grows.

• Serve as the primary data management lead for assigned clinical trials, ensuring timely,
  high-quality data deliverables throughout the data lifecycle.
• Develop and maintain study-specific data management plans (DMPs) and associated documents such as CRF completion guidelines, edit check specifications, and data transfer specifications.
• Oversee case report form (CRF) design
  , eCRF programming, and database setup activities in coordination with CRO partners and internal stakeholders.
• Coordinate and perform data review
  , query management, and data cleaning activities; support interim and final database lock processes
  .
• Ensure that data management practices are consistent with applicable regulatory requirements (e.g., ICH GCP, FDA) and industry best practices (e.g. GCDMP).
• Support the integration and reconciliation of external data sources
  , including central labs, imaging, biomarker, and other third-party data providers.

• Work closely with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs to align trial objectives, timelines, and data expectations.
• Act as the data management point-of-contact during study planning, conduct, and closeout phases.
• Lead Data Working Groups and cross-functional data review meetings to ensure data quality is maintained throughout the study.
• Contribute to the development of clinical trial protocols and statistical analysis plans (SAPs) from a data management perspective.

• Collaborate with and provide oversight of NUVB ex-US DM collaborators, CROs and third-party vendors
  , ensuring the quality and timeliness of deliverables.
• Participate in vendor selection and contracting activities; contribute to the development of vendor performance metrics.
• Ensure effective communication between vendors and internal teams to proactively address data-related issues.

• Contribute to the development and continuous improvement of data management processes, SOPs, and standards within the organization.
• Support regulatory inspections and audits by providing documentation and subject matter expertise as needed.
• May lead or participate in data-focused initiatives
  , such as implementing new data review tools and R shiny apps, standardizing data review workflows, or adopting novel data sources (e.g., ePRO, wearables).

• As the team grows, may provide mentorship or line management to junior CDM staff or contractors.
• Participate in training, onboarding, and professional development of new team members