Director, Clinical Data Management

• 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, * 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

The starting base pay range for this position is $207,709.00 - $235,935.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Pulled from the full job description

• Parental leave
• Health insurance
• 401(k) matching
• Vision insurance
• Dental insurance, Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
• 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!

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.

Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

Together we are moving psychiatry forward-beyond better, into a boundless future. Join us!