Remote Senior Director, Global Clinical Development

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

Job summary

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, to lead clinical development programs for OPDC products. The role offers remote work or placement in Rockville, MD or Princeton, NJ, with a focus on global trials, strategy, and regulatory coordination.

You will oversee Phase I–IV programs, interact with regulatory bodies, and drive life-cycle management across CNS and digital medicine products.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist with leadership experience.
• Supplementary degrees (Ph.D., M.P.H., M.B.A.) are a plus; other doctorates may be considered.
• Experience in the pharmaceutical industry or academic translational clinical research.
• Strong communication in meetings and written/oral presentations.
• Ability to manage and motivate team members; personnel management is a plus.

Responsibilities

• Consult with patients or representatives and external leaders to optimize trial objectives and plans.
• Develop internal medical/scientific consultation for health economics, medical affairs, regulatory, and other teams.
• Author program strategies, protocols, study reports, and oversee trials.
• Interpret and communicate Phase I–IV results for new drug development.
• Act as signatory on NDA submissions and clinical study documents.
• Provide strategic oversight of vendor/CRO relationships and governance input.
• Support regulatory filing activities and provide clear argumentation in communications.

Skills

MD/DO clinician

Leadership experience

Clinical pharmacology

Regulatory filings

Communication skills

Drug development knowledge

Biostatistics understanding

Travel ability

Team management

Education

MD/DO

PhD/MPH/MBA preferred

Tools

Microsoft Office

Job description

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, to lead clinical development programs for OPDC products. The role offers remote work or placement in Rockville, MD or Princeton, NJ, with a focus on global trials, strategy, and regulatory coordination.

You will oversee Phase I–IV programs, interact with regulatory bodies, and drive life-cycle management across CNS and digital medicine products.