Director, Clinical Data Management

<div class="content-intro"><p>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.&nbsp;&nbsp;</p> <p>Our lead&nbsp;product&nbsp;candidate,&nbsp;lysergide&nbsp;tartrate&nbsp;(our&nbsp;proprietary orally disintegrating tablet form of&nbsp;lysergide&nbsp;(LSD) D-tartrate),&nbsp;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.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p>Guided by&nbsp;the recognition&nbsp;that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address&nbsp;the&nbsp;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.&nbsp;</p> <p>Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!</p></div><p></p> <p><strong>Responsibilities:</strong></p> <ul> <li>Oversee CDM operations including CRF/eCRF design, validation programming, discrepancy management, and database development/production</li> <li>Provide oversight of CROs, vendors, and internal teams to maintain quality standards and performance metrics</li> <li>Ensure CDM documentation, SOPs, and processes support high data quality, integrity, and regulatory compliance with FDA, GCP, ICH, and GCDMP requirements</li> <li>Partner within Biometrics and Data Science as well as cross-functionally on data management issues and alignment</li> <li>Recruit, develop, motivate, and provide leadership to CDM staff and consultants</li> <li>Support resource planning, budget forecasting, timelines, and issue resolution for ongoing clinical trials</li> <li>Identify risks and challenges in clinical trial data management and propose solutions to maintain timelines and quality</li> <li>Escalate strategic, budgetary, or cross-functional issues when broader leadership input is required</li> <li>Ability to meet deadlines, prioritize workload, and handle multiple priorities simultaneously</li> <li>Experience with data visualization tools (e.g., Elluminate) (preferred)</li> <li>Must maintain an inspection-ready environment and support regulatory readiness</li> <li>Willingness to travel as needed</li> </ul> <p><strong>Qualifications:</strong></p> <ul> <li>Bachelor’s or Master’s degree in a scientific subject area</li> <li>Minimum of 8 years CDM experience in a pharmaceutical, biotech or CRO setting</li> <ul> <li>At least 4 years of line management experience</li> <li>Global or international experience is required</li> </ul> <li>Strong experience in cross functional leadership, clinical trial execution, vendor oversight, and inspection readiness</li> <li>Sophisticated knowledge of CDM processes, EDC systems, database programming, quality management and technology trends</li> <li>In-depth knowledge of FDA regulations, GCP, GCDMP, CDASH/CDISC, and ICH guidelines</li> <li>Strong leadership, mentoring, recruiting and team development skills</li> <li>Excellent communication, interpersonal, influencing and negotiation skills</li> <li>Strong problem-solving, analytical thinking, prioritization and organizational skills</li> <li>Ability to manage multiple priorities, adapt to changing business needs, and work collaboratively across functions</li> </ul> <p>&nbsp;</p> <p>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.</p> <p>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:</p> <ul> <li>100% paid health benefits including Medical, Dental and Vision for you and your dependents</li> <li>401(k) program with company match and vesting after the turn of the first month after your start date</li> <li>Flexible time off</li> <li>Generous parental leave and some fun fringe perks!</li> </ul> <p></p>