With supervision, oversees direction, planning, execution, and interpretation of clinical trials/research activities for a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting product scientific and business strategy.
Responsibilities:
- Manage design and implementation of study protocols (with appropriate supervision) aligned to the Product Development Plan; educate investigators, study site personnel, and study staff.
- Oversee clinical studies: ensure study integrity; review/interpret/communicate accumulating safety and efficacy data; oversee enrollment and key deliverable timelines (with Clinical Operations); assess/report serious adverse events per policy and regulations.
- Contribute to design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- Serve as clinical representative on Clinical Strategy Team; contribute to a cross-functionally aligned Clinical Development Plan.
- Participate in opinion leader interactions with Medical Affairs/Commercial and others.
- Maintain expertise via conferences, literature, and training.
- Understand and comply with regulatory requirements for global drug development; may support regulatory responses/discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- Medical Director: MD/DO (or non-US equivalent) with relevant specialty; residency strongly preferred; psychiatry fellowship desirable; ability to run clinical research study with appropriate supervision; cross-functional collaboration; clinical trial experience preferred; knowledge of clinical trial methodology and regulatory/compliance requirements desirable; excellent oral/written English.
- Senior Medical Director: MD/DO (or non-US equivalent) with relevant specialty; psychiatry residency strongly preferred; at least 2 years clinical trial experience; translational research preferred; ability to run moderate complexity program with minimal supervision; cross-functional leadership; knowledge of clinical trial methodology/regulatory/compliance and clinical strategy/protocol design; excellent oral/written English.
Benefits (if applicable to this location): paid time off, medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.