Director, Clinical Data Management

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production • Provide oversight of CROs, vendors, and internal teams to maintain quality standards and performance metrics • Ensure CDM documentation, SOPs, and processes support high data quality, integrity, and regulatory compliance with FDA, GCP, ICH, and GCDMP requirements • Partner within Biometrics and Data Science as well as cross-functionally on data management issues and alignment • Recruit, develop, motivate, and provide leadership to CDM staff and consultants • Support resource planning, budget forecasting, timelines, and issue resolution for ongoing clinical trials • Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and quality • Escalate strategic, budgetary, or cross-functional issues when broader leadership input is required • Ability to meet deadlines, prioritize workload, and handle multiple priorities simultaneously • Experience with data visualization tools (e.g., Elluminate) (preferred) • Must maintain an inspection-ready environment and support regulatory readiness • Willingness to travel as needed

🎯 Requirements

• Bachelor’s or Master’s degree in a scientific subject area • Minimum of 8 years CDM experience in a pharmaceutical, biotech or CRO setting • At least 4 years of line management experience • Global or international experience is required • Strong experience in cross functional leadership, clinical trial execution, vendor oversight, and inspection readiness • Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology trends • In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines • Strong leadership, mentoring, recruiting and team development skills • Excellent communication, interpersonal, influencing and negotiation skills • Strong problem-solving, analytical thinking, prioritization and organizational skills • Ability to manage multiple priorities, adapt to changing business needs, and work collaboratively across functions

🏖️ Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents • 401(k) program with company match and vesting after the turn of the first month after your start date • Flexible time off • Generous parental leave and some fun fringe perks!