Remote Senior Director, Global Clinical Development

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

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development, for remote-based work or in our Rockville, MD or Princeton, NJ offices.

You will design and oversee CNS and Digital Medicine clinical programs in a global healthcare market, leading scientific and regulatory strategy across development stages. The role requires MD/DO with leadership experience, strong communication, and deep drug development knowledge.

Qualifications

• M.D. or D.O. with clinical background; psychiatry/neurology preferred.
• 6–9 years in pharma or translational clinical research for Senior Director level.
• Strong knowledge of clinical medicine and science management.
• Effective communication in meetings and written/oral presentations.
• Experience leading, managing, and mentoring team members.
• Deep understanding of drug development principles and clinical trial execution.
• Flexibility to work across therapeutic areas and development stages.
• Knowledge of biostatistics, clinical pharmacology, formulation science, data management and medical writing.
• Familiarity with global regulatory requirements and filings; advantageous.
• Understanding of health value creation, budgeting, market research and commercialization.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC-GCD products under GCP.
• Evaluates and develops CNS and Digital Medicine products across development stages for global markets.
• Advises internal teams and regulators with medical/scientific expertise.
• Authors program strategies, protocols, study reports, and oversees trials for safety and efficacy.
• Interprets Phase I–IV results to inform NDA submissions and regulatory strategies.
• Provides strategic oversight of vendor/CRO relationships and governance involvement.

Skills

Clinical leadership

GCP knowledge

Medical writing

Regulatory filings

Communication skills

Team management

Pharmacology knowledge

Biostatistics understanding

Travel readiness

Microsoft Office

Education

MD/DO (psychiatry/neurology preferred)

Supplementary degrees (Ph.D., MPH, MBA) a plus

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development, for remote-based work or in our Rockville, MD or Princeton, NJ offices.

You will design and oversee CNS and Digital Medicine clinical programs in a global healthcare market, leading scientific and regulatory strategy across development stages. The role requires MD/DO with leadership experience, strong communication, and deep drug development knowledge.