Global Clinical Development Director — CNS & Digital Medicine

Otsuka America Pharmaceutical Inc.; Madison (WI); Remote; USD 180,000 - 240,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development, remote-based or based in Rockville, MD, or Princeton, NJ.

You will design and oversee clinical research programs and protocols for OPDC products under good clinical practices. The role includes leading development of CNS and Digital Medicine products, supplying strategic direction, and managing vendor and CRO relationships while supporting regulatory filings and international collaborations.

Qualifications

• MD/DO or equivalent medical degree required; supplementary degrees a plus.
• 6–9 years in pharma/academic translational clinical research typically required for senior level.
• Strong knowledge of clinical medicine and science management with focus on achieving outcomes.
• Excellent communication in meetings and in written/oral presentations; proficient with MS Office.
• Leadership experience managing teams; prior personnel management preferred.
• Understanding of drug development principles and clinical trial execution and reporting.

Responsibilities

• Designs and oversees clinical research programs and protocols under GCP.
• Evaluates CNS and Digital Medicine products across development stages.
• Leads regulatory filings and prepares submissions.
• Provides strategic direction and oversight of vendors and CROs.
• Supports global regulatory filings and international collaboration.
• Willingness to travel ~30% domestically and internationally.

Skills

Clinical leadership

Regulatory filings

Team management

Biostatistics

Medical writing

Communication

Microsoft Office

Education

MD/DO

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development, remote-based or based in Rockville, MD, or Princeton, NJ.

You will design and oversee clinical research programs and protocols for OPDC products under good clinical practices. The role includes leading development of CNS and Digital Medicine products, supplying strategic direction, and managing vendor and CRO relationships while supporting regulatory filings and international collaborations.