Director, Clinical Development Scientist (Non-MD)
Core
Scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, leading execution of one or more studies.
Role type
Director, Clinical Development Scientist (Non-MD)
Builds
Clinical deliverables for one or more studies
Domain
Biopharmaceutical industry, Internal Medicine
Required skills
Clinical trial execution, protocol design and amendments, statistical analysis plan guidance, clinical data collection strategy, safety review plan development, risk management plan establishment, external data monitoring committee management, site selection criteria development, regulatory filing support, audit and inspection support
Preferred skills
Cardiometabolic disease experience, scientific productivity via publications, extensive knowledge of ICH/GCP, clinical administrative and project management, team leadership and mentoring, conflict resolution, AI tool usage
Technologies
ChatGPT, Microsoft Copilot
Responsibilities
Lead clinical execution of studies, develop protocols and amendments, provide clinical guidance on data and safety plans, manage external committees, ensure TMF compliance, support regulatory filings, manage protocol deviations, contribute to publications, support audits and inspections
Seniority
Director, hands-on IC with management responsibilities