Senior Director, Clinical Development

Responsibilities

• Provide clinical science leadership within assigned teams or programs
• Manage the design, planning, and execution of clinical trial programs
• Lead study design, implementation, and execution of clinical trials
• Prepare clinical study synopses and contribute to protocol writing and major amendments
• Identify and cultivate relationships with national and international thought leaders
• Oversee the quality and timeliness of clinical sections of INDs, Investigator Brochures, and CTAs
• Provide or supervise medical monitoring activities, including safety management and adverse event reporting
• Conduct ongoing benefit/risk assessments and monitor protocol adherence

Requirements

• Doctoral level degree (PhD, MD, PharmD, or PsyD)
• 6+ years of relevant clinical development experience
• Experience in small molecule development
• Experience in data review, analysis, and regulatory writing (IND, CTD sections)
• Strong knowledge of the clinical development process and pharmaceutical industry
• Proven ability to work remotely with interdisciplinary teams
• Ability to travel as required (average 10-20%, up to 50%+ in some months)

Preferred Qualifications

• Experience in CNS development (Psychiatry or neurology)
• Experience in clinical research for psychiatry, addiction psychiatry, or addiction medicine
• Strong IND experience
• Managerial skills

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.