Global Clinical Development Director – Remote/Hybrid

Annual Dialysis Conference; Northern (KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Otsuka is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products. The role can be remote or based in Princeton, NJ or Rockville, MD, with 30% travel for global activities.

The candidate will lead cross-functional teams, author program strategies, manage trials from early to late stages, and contribute to regulatory filings and health value assessments.

Qualifications

• Clinical medicine knowledge and science management
• 3–6 years in pharma or translational clinical research
• Ability to communicate effectively in meetings and presentations
• Advanced understanding of drug development principles and trial implementation
• Willingness to travel 30% and international travel

Responsibilities

• Consults with patients and leaders to optimize trial objectives, designs and protocols
• Authors program strategies and oversees trials essential for safety, efficacy and value
• Interprets Phase I–IV results for NDA submissions and communications
• Provides strategic oversight of vendor and CRO relationships and governance
• Supports regulatory filing activities and prepares concise written communications

Skills

Clinical development

Regulatory filings

Team leadership

Communication

Vendor management

Medical writing

Education

MD/DO

PhD/MPH/MBA a plus

Tools

MS Word

Excel

PowerPoint

Outlook

Job description

Otsuka is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products. The role can be remote or based in Princeton, NJ or Rockville, MD, with 30% travel for global activities.

The candidate will lead cross-functional teams, author program strategies, manage trials from early to late stages, and contribute to regulatory filings and health value assessments.