Role:
The Clinical Development Scientist (Director) provides scientific oversight and ensures data integrity and quality across clinical trials in Internal Medicine, managing clinical deliverables for multiple studies.
Responsibilities:
- lead clinical execution
- contribute to protocol development
- represent the study team in governance and regulatory interactions
- guide safety and data review strategies
- develop site selection criteria
- support regulatory submissions
- May supervise and mentor team members.
Requirements:
PhD, PharmD, or similar with 5+ years (or MA/MS with 7+ years, BA/BS with 8+ years) in clinical research within biopharma, with experience in study design, conduct, and regulatory processes.
Preferred:
cardiometabolic disease expertise, extensive knowledge of GxP, ICH/GCP, and global clinical development; proven leadership, communication, and team management skills.
HighValue:
Internal Medicine focus, clinical trial oversight, regulatory interaction, safety monitoring, cross-functional collaboration, hybrid work setup with international travel expected.
#J-18808-LjbffrDirector, Clinical Development Scientist (Non-MD) in cambridge at Unknown Company
This position is listed as full time and hybrid.