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