Clinical Development Scientist, Senior Manager
Core
Provides scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, including protocol design, safety review, and regulatory support.
Role type
Senior Manager, Clinical Development Scientist
Builds
Clinical trials for biopharmaceutical products
Domain
Biopharmaceuticals, Internal Medicine
Required skills
Clinical trial management, protocol design, safety data review, regulatory submissions, team leadership, data integrity, risk management, site selection, statistical analysis plan input
Preferred skills
Cardiometabolic disease experience, clinical research in study design/start-up/conduct/close-out, scientific publications, ICH/GCP knowledge, AI tool usage
Technologies
ChatGPT, Microsoft Copilot
Responsibilities
Provide clinical support for studies, contribute to protocol design and amendments, review safety data and narratives, support regulatory filings, manage External Data Monitoring Committees, ensure TMF compliance, mentor and supervise team members
Seniority
Senior, hands-on IC with leadership responsibilities