Remote Global Clinical Development Director

Rhode Island Bar Assn.; Princeton (NJ); Remote; 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, working remotely or from Princeton, NJ or Rockville, MD. The role advances development across rheumatology, immunology and specialty medicine in a global health-care market.

You will lead cross-functional teams, interact with regulators, authors program strategies, manage vendor relationships, and support regulatory filings, while constantly seeking innovations to

Qualifications

• Clinician with MD/DO; rheumatology/immunology/dermatology/nephrology preferred.
• 3–6 years pharma or translational clinical research experience.
• Strong knowledge of clinical medicine and project management; business outcomes focus.
• Excellent written and verbal communication; proficient with Microsoft Office.
• Experience leading teams or managing personnel preferred.
• Understanding of drug development and cross-therapeutic flexibility across therapeutic areas.
• Knowledge of biostatistics, clinical pharmacology, data management, and medical writing.
• Understanding global regulatory requirements; regulatory filings a plus.
• Familiarity with health economics, budgeting, market research and commercialization strategies.
• Willingness to travel ~30% and international travel.

Responsibilities

• Designs and oversees clinical research programs and protocols.
• Serves as internal medical/scientific consultant to cross-functional teams and external/regulatory bodies.
• Authors program strategies and oversees NDA submissions and safety documents.
• Interprets Phase I–IV results for NDA preparation and product development decisions.
• Oversees vendor and CRO relationships; contributes to governance committees.
• Supports regulatory filing activities and communications.
• Drives product lifecycle management and pursues value-adding innovations.
• Travels internationally to support global development activities.

Skills

Communication

Leadership

Strategic thinking

Collaboration

Regulatory knowledge

Budgeting

Travel readiness

Education

MD/DO

PhD/MPH/MBA

Other clinical doctorates considered

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka seeks a Director, Global Clinical Development (GCD) to design and oversee clinical research programs for OPDC products, working remotely or from Princeton, NJ or Rockville, MD. The role advances development across rheumatology, immunology and specialty medicine in a global health-care market.

You will lead cross-functional teams, interact with regulators, authors program strategies, manage vendor relationships, and support regulatory filings, while constantly seeking innovations to