Global Clinical Development Director - Remote

ISHE; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Otsuka seeks a Director, Global Clinical Development (GCD) to design and oversee clinical research programs for OPDC products. The role can be remote or based in Princeton, NJ or Rockville, MD, with responsibility for Rheumatology, Immunology and Specialty Medicine programs globally.

The incumbent will lead clinical strategy, vendor relationships, and regulatory filings, while guiding teams across medical, scientific, and regulatory functions to optimize trial outcomes and value creation.

Qualifications

• MD or DO with clinical background in rheumatology, nephrology, immunology or dermatology.
• 3-6 years pharma/academic translational clinical research experience.
• Strong understanding of drug development, regulatory strategy and medical writing.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Leads cross-functional teams across clinical, regulatory and scientific groups.
• Provides strategic direction and writes/edits NDA submissions and safety documents.
• Oversees vendor/CRO relationships and contributes to regulatory filings.

Skills

Accountability

Strategic thinking

Effective communication

Team leadership

Cross-functional collaboration

Problem solving

Adaptability

Stakeholder management

Education

MD or DO

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Otsuka seeks a Director, Global Clinical Development (GCD) to design and oversee clinical research programs for OPDC products. The role can be remote or based in Princeton, NJ or Rockville, MD, with responsibility for Rheumatology, Immunology and Specialty Medicine programs globally.

The incumbent will lead clinical strategy, vendor relationships, and regulatory filings, while guiding teams across medical, scientific, and regulatory functions to optimize trial outcomes and value creation.