Global Clinical Development Director — Remote

Sustainable World, Inc.; 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 programs for OPDC products, remotely or in Princeton, NJ, or Rockville, MD. The role leads trials across Rheumatology, Immunology and Specialty Medicine with global scope.

The candidate will drive trial objectives, manage teams, coordinate regulatory filings, and guide health-economic and medical affairs input, while navigating multi-therapy development programs.

Qualifications

• Clinician with MD/DO and preferred specialization in rheumatology, nephrology, immunology or dermatology.
• Strong clinical medicine knowledge and science management capabilities.
• Ability to lead, manage and motivate teams and external investigators.
• Effective communication in meetings and written/oral presentations.
• Understanding of drug development principles and regulatory filings.

Responsibilities

• Consult with patients, clinical leaders and stakeholders to optimize trial objectives and designs.
• Develop internal medical/scientific expertise for various teams and regulators.
• Authors program strategies and oversees trials essential for safety and value.
• Interpret Phase I–IV results and prepare for NDA submissions and safety documents.
• Provide strategic oversight of vendor/CRO relationships and governance.

Skills

Clinical expertise

Leadership experience

Strategic thinking

Communication skills

Regulatory knowledge

Education

MD/DO in rheumatology/nephrology/immunology/dermatology

Supplementary degrees (PhD/MPH/MBA) a plus

Tools

Microsoft Office Suite

Job description

Otsuka is seeking a Director, Global Clinical Development to design and oversee clinical programs for OPDC products, remotely or in Princeton, NJ, or Rockville, MD. The role leads trials across Rheumatology, Immunology and Specialty Medicine with global scope.

The candidate will drive trial objectives, manage teams, coordinate regulatory filings, and guide health-economic and medical affairs input, while navigating multi-therapy development programs.