Clinical Development Director - Psychiatry

Director Clinical Development - Psychiatry

Company Overview

We are a cutting-edge, patient-centric biotechnology company focused on developing transformative therapies for neuropsychiatric and central nervous system (CNS) disorders. Our pipeline includes novel small molecules and biologics targeting high unmet needs in areas such as major depressive disorder, schizophrenia, bipolar disorder, and rare CNS diseases. As we advance multiple assets into and through clinical development, we are seeking a strategic and hands-on Director of Clinical Development to join our growing team.

Position Summary

The Director, Clinical Development – Psychiatry/CNS will lead the planning and execution of clinical development strategies for investigational drugs targeting psychiatric and CNS indications. This individual will serve as the clinical lead on cross-functional project teams, be responsible for protocol development and clinical oversight, and collaborate closely with medical, regulatory, safety, and operational colleagues.

Key Responsibilities

• Lead the design, execution, and interpretation of Phase I–III clinical trials in psychiatric and CNS indications.

• Develop and maintain clinical development plans (CDPs), clinical study protocols, investigator brochures, and regulatory documents (e.g., INDs, NDAs, Briefing Documents).

• Provide medical and scientific leadership to study teams, CROs, and clinical investigators.

• Serve as medical monitor for ongoing trials, ensuring patient safety and data integrity.

• Collaborate with biostatistics, data management, and regulatory affairs to ensure quality execution and timely delivery of milestones.

• Represent the company in regulatory interactions (FDA, EMA) and in external scientific and medical forums.

• Contribute to clinical sections of regulatory submissions and publications.

• Stay abreast of emerging science, competitive landscape, and treatment paradigms in neuropsychiatry and CNS.

• Manage and mentor junior medical/scientific staff, as appropriate.

Qualifications

• MD required; board certification in Psychiatry, Neurology, or related CNS specialty preferred.

• 7+ years of experience in clinical development within the biotech/pharma industry, including experience as a medical lead on psychiatry or CNS trials.

• Demonstrated success leading cross-functional teams and clinical programs from IND through late-stage development.

• Experience with regulatory agency interactions and submissions (e.g., IND, NDA, CTA).

• Strong understanding of GCP, ICH guidelines, and global regulatory requirements.

• Strategic thinker with excellent scientific, analytical, and communication skills.

• Passion for innovation and making a difference in patients’ lives.

Why Join Us

• Opportunity to shape the development of novel therapies with high patient impact.

• Dynamic, fast-paced, and collaborative biotech environment.

• Competitive compensation, equity participation, and comprehensive benefits package.

#LI-OG1