Global Clinical Dev Lead - CNS & Digital (Remote)

Otsuka Pharmaceutical Co., Ltd; United States; Hybrid; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Prescription drug coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Paid time off

Paid holidays

Paid leave programs

Job summary

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, either remote or in our Rockville, MD or Princeton, NJ offices. You will design and oversee clinical programs for OPDC products, especially CNS and digital medicine, ensuring high-quality development and regulatory readiness.

You will guide development strategies, lead trials across phases, manage vendor and CRO relationships, and support regulatory filings while traveling as needed to advance global programs.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist with management experience.
• Experience in pharmaceutical industry or academic translational clinical research.
• Strong communication in meetings and written/oral presentations.
• Advanced understanding of drug development principles and clinical trials.

Responsibilities

• Consult with leaders to optimize trial objectives, designs, and development plans.
• Authors program strategies, protocols, study reports, and oversees trials.
• Interpret results of Phase I–IV investigations for regulatory filings.
• Provide strategic direction in vendor/CRO relationships and governance.
• Lead regulatory filing activities and ensure concise communications.
• Support product life cycle management and innovative value strategies.

Skills

Clinical development

Leadership

Regulatory filings

Biostatistics

Medical writing

Vendor management

CRO relationships

Team management

Strategic thinking

Communication skills

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, either remote or in our Rockville, MD or Princeton, NJ offices. You will design and oversee clinical programs for OPDC products, especially CNS and digital medicine, ensuring high-quality development and regulatory readiness.

You will guide development strategies, lead trials across phases, manage vendor and CRO relationships, and support regulatory filings while traveling as needed to advance global programs.