Associate Director, Clinical Development

Company Overview

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!

Position Summary

The Associate Director, Clinical Development plays a key role in the design and execution of ongoing and new clinical development studies. This position serves as the clinical science representative on one or more U.S. and/or global clinical studies and contributes to the delivery of high‑quality clinical data to support registration and launch. The role partners cross‑functionally with Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Early Development, Medical Affairs, Commercial, and external vendors.

Responsibilities

• Serve as a responsible member and clinical science representative on global development teams
• Collaborate with cross‑functional partners to provide clinical development expertise in support of study execution
• Provide therapy‑area medical and scientific expertise in the evaluation and presentation of clinical trial data
• Write and edit clinical protocols, clinical study reports, manuscripts, and other study‑related documents
• Support the quality, coordination, and timeliness of clinical sections of regulatory deliverables (e.g., INDs, Investigator Brochures, CTAs, ISS/ISE, clinical expert reports) in partnership with Regulatory Affairs and Project Management
• Review and monitor patient‑level and study‑level data, including participation in blinded data review and use of data science approaches as applicable
• Collaborate with statisticians and programmers on statistical analysis plans and interpretation of clinical data
• Work with Medical Writing to support abstracts, manuscripts, and presentations for external scientific meetings
• Act as the clinical science lead to CROs and external vendors, with appropriate oversight from senior leadership
• Contribute to a culture of innovation, collaboration, and continuous improvement
• Perform additional responsibilities as assigned by leadership

Qualifications

• Doctoral degree required (PhD, MD, PharmD, PsyD, MA, LCSW)
• Minimum of 3 years of clinical development experience
• Experience in CNS development (psychiatry or neurology) strongly preferred
• Strong understanding of late‑stage clinical development and regulatory processes
• Experience in data review, analysis, and regulatory writing (e.g., IND and CTD sections)
• Demonstrated ability to work collaboratively across functions
• Excellent wri