Clinical Development Director for CNS & Digital Medicine

Colorado Psychiatric; Princeton (NJ); Hybrid; USD 180,000 - 260,000; Full time

Job summary

Otsuka invites applications for a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ. You will design and oversee clinical research programs and protocols for OPDC products under GCP, and guide development across CNS and Digital Medicine products for a global market.

You will lead cross-functional teams, interact with regulatory bodies, provide strategic input on vendor/CRO governance, and drive regulatory filings.

Qualifications

• A clinician with MD/DO (psychiatry/neurology preferred) and management experience.
• 6+ years in pharma, clinical research or translational studies.
• Strong communication and leadership across multi-disciplinary teams.

Responsibilities

• Designs and oversees clinical research programs and protocols.
• Evaluates CNS and Digital Medicine products across development stages.
• Leads program strategies and oversees essential trials.
• Interprets Phase I-IV results for regulatory submissions.
• Provides governance input for vendor/CRO relationships.
• Supports regulatory filings with concise communications.

Skills

Leadership

Regulatory filings

Medical writing

Biostatistics

Clinical pharmacology

Vendor management

Travel 30% willingness

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Office

Job description

Otsuka invites applications for a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ. You will design and oversee clinical research programs and protocols for OPDC products under GCP, and guide development across CNS and Digital Medicine products for a global market.

You will lead cross-functional teams, interact with regulatory bodies, provide strategic input on vendor/CRO governance, and drive regulatory filings.