Director, Clinical Data Management

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company on a mission to forge a new era of psychiatry by applying scientific rigor to psychedelics. Headquartered in New York and trading on Nasdaq, the company aims to develop accessible treatments for generalized anxiety, major depressive disorder, and PTSD.

Responsibilities

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development
• Provide oversight of CROs, vendors, and internal teams to maintain quality standards
• Ensure CDM documentation, SOPs, and processes support regulatory compliance with FDA, GCP, ICH, and GCDMP
• Partner within Biometrics and Data Science and cross-functionally on data management issues
• Recruit, develop, and provide leadership to CDM staff and consultants
• Support resource planning, budget forecasting, timelines, and issue resolution
• Identify risks in clinical trial data management and propose solutions
• Maintain an inspection-ready environment and support regulatory readiness

Requirements

• Bachelor’s or Master’s degree in a scientific subject area
• Minimum of 8 years CDM experience in pharmaceutical, biotech, or CRO settings
• At least 4 years of line management experience
• Required global or international experience
• Strong experience in cross-functional leadership, clinical trial execution, and vendor oversight
• Sophisticated knowledge of CDM processes, EDC systems, and database programming
• In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines

Preferred Qualifications

• Experience with data visualization tools such as Elluminate