Global Clinical Development Director: Rheumatology/Immunology

Sustainable World, Inc.; Princeton (NJ); Remote; USD 180,000 - 240,000; Full time

Job summary

Otsuka is seeking a Director, Global Clinical Development (GCD) to design and oversee clinical programs for OPDC products, with options to work remotely or from Princeton, NJ or Rockville, MD.

The role leads trials across Rheumatology, Immunology and Specialty Medicine, collaborates with regulatory, medical affairs and CROs, and drives strategic submissions and life-cycle plans, including global regulatory filings and safety documents.

Qualifications

• MD or DO with rheumatology, nephrology or immunology background; management experience a plus.
• 3–6 years in pharmaceutical industry or academic translational clinical research.
• Strong knowledge of clinical medicine and science management; ability to drive outcomes on time and budget.
• Excellent written/spoken communication; proficient in Microsoft Office suite.

Responsibilities

• Consult with patients and leaders to optimize trial objectives, designs and protocols.
• Serve as internal medical/scientific consultant to cross-functional teams and regulators.
• Authors program strategies and oversees trials for safety, efficacy and value.
• Interpret and communicate Phase I–IV results for regulatory submissions.
• Provide oversight of vendor and CRO relationships and governance.
• Support regulatory filing activities and craft clear written/verbal communications.

Skills

Clinical leadership

Communication skills

Team leadership

Regulatory knowledge

MS Office proficiency

Education

M.D./D.O.

Ph.D. (optional)

MPH (optional)

MBA (optional)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka is seeking a Director, Global Clinical Development (GCD) to design and oversee clinical programs for OPDC products, with options to work remotely or from Princeton, NJ or Rockville, MD.

The role leads trials across Rheumatology, Immunology and Specialty Medicine, collaborates with regulatory, medical affairs and CROs, and drives strategic submissions and life-cycle plans, including global regulatory filings and safety documents.