Clinical Study Physician - Dermatology & GI

Role Summary

The Clinical Trial Physician (CTP), Director, sits within Clinical Development and contributes to the design and implementation of the clinical development plan, working with the Disease Area Head, Clinical Development Lead, Clinical Scientist, and other functional areas. The Director will contribute to INDs, NDAs, BLAs, and other global regulatory filings and publications, and foster relationships with opinion leaders in the assigned therapeutic area.

The CTP is a member of the study team and CDT. The CTP is expected to advance scientific and clinical knowledge and pro-actively progress study execution.

Location:

Hybrid schedule (2-3 days/week onsite) in Parsippany, NJ or West Chester, PA, with remote flexibility; travel approximately 20% domestically and internationally.

• Serve as a primary source of medical accountability and oversight for one or more clinical trials
• Matrix management responsibilities across the internal and external network
• Manages Phase 1–3 studies (depending on assignment) with demonstrated decision-making capabilities
• Provides medical and scientific expertise to cross-functional colleagues

• Required:
  
  MD or DO
• Required:
  
  A minimum of 3 years in a pharmaceutical industry, CRO, or other health-related scientific field; planning/managing clinical trials or with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
• Required:
  
  Knowledge of regulatory requirements governing clinical trials and experience in the design and successful execution of clinical trials
• Preferred:
  Experience performing protocol design in the academic environment and/or acted as an assistant Principal Investigator or Principal Investigator
• Preferred: FDA reviewer for the disease area

• Excellent interpersonal, verbal and written scientific communication skills (English)
• Ability to manage multiple conflicting priorities and varied concurrent tasks
• Strong sense of urgency and ability to thrive in a fast-paced, multi-tasking environment
• Ability to interface professionally with a wide spectrum of internal and external academicians, agencies and industry executives in the scientific/medical arena

• Travel:
  Approximately 20% domestic and international