Director, Clinical Data Management
About The Position
Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing accessible treatments for psychiatric disorders using psychedelics. Our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics. Our lead product candidate, lysergide tartrate, is being developed for generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our pipeline also includes DT402, targeting core symptoms of autism spectrum disorder. We aim to change the trajectory of mental health care by addressing the underlying causes of psychiatric and neurological disorders. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX. We are moving psychiatry forward into a boundless future.
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
Nice To Haves
- Experience with data visualization tools (e.g., Elluminate)
Responsibilities
- 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
- Must maintain an inspection-ready environment and support regulatory readiness
- Willingness to travel as needed
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
- Some fun fringe perks
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
