Clinical Development Director

Job Summary

Seeking a full-time Director, Global Clinical Development, who will be responsible for designing and overseeing clinical research programs for OPDC products, focusing on Rare Diseases and Specialty Medicine, with the option to work remotely or from Princeton, NJ, or Rockville, MD.

Key responsibilities

• Consults with stakeholders to optimize trial objectives, designs, and protocols
• Authors program strategies and oversees trials to assess the clinical safety and efficacy of product candidates
• Provides strategic oversight in vendor and CRO relationships and supports regulatory filing activities

Required qualifications

• M.D. or D.O. with a background in genetics, metabolic diseases, or immunology; other clinical/scientific doctorates may be considered
• 3-6 years of experience in the pharmaceutical industry or academic translational clinical research
• Thorough knowledge of clinical medicine and drug development principles
• 5 years of experience in clinical research or drug development across Phases I-IV
• Advanced understanding of global regulatory requirements and successful regulatory filings