Clinical Development Director, CNS & Digital Medicine

Otsuka America Pharmaceutical Inc.; Jackson (MS); Remote; USD 180,000 - 280,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Director, Global Clinical Development. This remote-based role (option to base in Rockville, MD or Princeton, NJ) leads design and oversight of global clinical programs for OPDC-GCD.

You will direct CNS and digital medicine development, collaborate with regulatory, medical writing, and biostatistics teams, and drive strategic filings and lifecycle activities. Travel up to 30% is expected.

Qualifications

• A clinician (MD/DO) preferably psychiatry/neurology with leadership experience.
• 6–9 years pharma or translational clinical research experience for senior director level.
• Strong knowledge of clinical medicine and science management.
• Excellent written and oral communication; MS Office skills.
• Experience leading teams; prior personnel management helpful.
• Deep understanding of drug development and clinical trials.
• Ability to work across therapies and development stages.
• Knowledge of biostatistics, pharmacology, data management, medical writing.
• Understanding global regulatory requirements; filing experience is a plus.
• Understanding health value creation: budgeting, market research, NPV.
• Willingness to travel 30% internationally.

Responsibilities

• Design and oversight of clinical research programs.
• Evaluate CNS and Digital Medicine products across development stages.
• Internal medical/scientific consultant to teams and regulators.
• Author program strategies, protocols, and study reports.
• Interpret Phase I–IV results for NDA submissions.
• Lead regulatory filings and oversee vendor/CRO relationships.
• Support lifecycle management and strategic signaling for value.

Skills

Clinical leadership

Regulatory filings

Medical writing

Clinical pharmacology

Biostatistics

Travel

Team management

Education

MD/DO

PhD/MPH/MBA

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks a Senior Director, Global Clinical Development. This remote-based role (option to base in Rockville, MD or Princeton, NJ) leads design and oversight of global clinical programs for OPDC-GCD.

You will direct CNS and digital medicine development, collaborate with regulatory, medical writing, and biostatistics teams, and drive strategic filings and lifecycle activities. Travel up to 30% is expected.