Associate Director, Clinical Development

Definium Therapeutics; Durham (NC); On-site; USD 170,000 - 192,000; Full time

Benefits offered by this job

100% paid health benefits (Medical, D,

Vision & Dental coverage

Job summary

Definium Therapeutics, a late-stage clinical biopharmaceutical company, seeks a Clinical Science lead to guide global CNS development programs. You will integrate medical writing, data interpretation, and cross-functional collaboration to support study execution and regulatory submissions.

The role requires a Doctoral degree and 3+ years in clinical development, with strong CNS experience, ability to manage external vendors, and willingness to travel 10–20%.

Qualifications

• PhD/MD/PharmD/PsyD or equivalent required.
• Experience in late-stage clinical development and regulatory processes.
• Strong ability to write and edit regulatory documents (IND/CTD).
• Proven collaboration across functions and teams.

Responsibilities

• Serve as clinical science representative on global development teams.
• Provide therapy-area medical expertise for study execution.
• Write/edit clinical protocols, study reports, and manuscripts.
• Support regulatory deliverables and coordination with Regulatory Affairs.
• Review data and collaborate on statistical analysis and interpretation.
• Lead CROs and external vendors with senior leadership oversight.
• Contribute to innovation, collaboration, and continuous improvement.

Skills

Cross-functional collaboration

Regulatory writing

Excellent communication

Data interpretation

Project coordination

Education

Doctoral degree

Job description

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!

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 written and verbal communication skills

Other Skills & Requirements

• Managerial experience a plus
• Proven ability to anticipate challenges and propose thoughtful, evidence‑based solutions
• Willingness to travel as required, including international travel (typically 10–20%, may reach higher during peak periods)

The starting base pay range for this position is $169,814.00 - $192,241.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

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!