Associate Director, Clinical Development

Responsibilities

• Serve as a 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)
• Review and monitor patient-level and study-level data, including participation in blinded data review
• 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

Requirements

• Doctoral degree (PhD, MD, PharmD, PsyD, MA, LCSW)
• Minimum of 3 years of clinical development experience
• Strong understanding of late-stage clinical development and regulatory processes
• Experience in data review, analysis, and regulatory writing
• Excellent written and verbal communication skills
• Willingness to travel 10–20%

Preferred Qualifications

• Experience in CNS development (psychiatry or neurology)
• Managerial experience

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match
• Flexible time off
• Generous parental leave

About the Company

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on applying scientific rigor to psychedelics to develop accessible treatments for psychiatric and neurological disorders.