Global Clinical Development Director CNS & Digital Medicine

Cim; Princeton (NJ); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Otsuka is seeking a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ to design and oversee clinical research programs for OPDC products under GCP. The role focuses on CNS and Digital Medicine across development stages for a global healthcare market.

The ideal candidate will lead medical strategy, oversee trials, and guide NDA submissions while collaborating with regulatory, marketing, and clinical teams. Travel up to 30% is anticipated.

Qualifications

• MD or DO with clinical background; psychiatrist/neurologist preferred.
• Experience in pharma or translational clinical research 6+ years.
• Experience with regulatory filings and cross-functional teams.

Responsibilities

• Design and oversight of clinical research programs and protocols under GCP.
• Lead internal medical/scientific consultations for research teams and regulators.
• Author program strategies and oversee trials for safety, efficacy and value.
• Interpret Phase I–IV results for NDA readiness and regulatory submissions.
• Provide strategic oversight of vendor and CRO relationships.
• Support regulatory filing activities with clear, concise communications.

Skills

Clinical development

Team leadership

Regulatory submissions

Vendor management

Education

Medical degree (MD/DO)

PhD/MPH/MBA

Tools

Microsoft Office

Job description

Otsuka is seeking a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ to design and oversee clinical research programs for OPDC products under GCP. The role focuses on CNS and Digital Medicine across development stages for a global healthcare market.

The ideal candidate will lead medical strategy, oversee trials, and guide NDA submissions while collaborating with regulatory, marketing, and clinical teams. Travel up to 30% is anticipated.