Role: Senior Manager, Clinical Development Scientist overseeing clinical trials in Internal Medicine, with responsibility for scientific oversight, data integrity, and quality assurance across studies.
Responsibilities
- contributing to protocol design
- supporting study governance and safety plans
- data review
- safety monitoring
- site selection
- investigator interactions
- regulatory documentation
- The role also entails mentoring team members
- supporting audits
- contributing to publications and regulatory submissions
Requirements
- PhD, PharmD, or equivalent with 1+ years (or MA/MS with 5+ years, BA/BS with 6+ years) industry experience in clinical research
- strong knowledge of clinical development processes, GxP, ICH/GCP, and experience in regulatory interactions
Preferred
- cardiometabolic disease expertise
- experience in study start-up and regulatory filings
- publication record
- leadership skills
- ability to manage complex projects
High-Value
focus on clinical trials in Internal Medicine, potentially involving biologics or small molecules, with responsibilities spanning from protocol development through to data analysis and safety oversight.
Work setup
hybrid in U.S., requiring on-site presence ~2.5 days/week, with potential for global travel.
#J-18808-LjbffrClinical Development Scientist, Senior Manager in san diego at Unknown Company
This position is listed as full time and hybrid.