Senior Director, Clinical Development
Remotedxb
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.
#J-18808-LjbffrVacancy posted 1 day ago
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