Director, Clinical Development Scientist (Non-MD)
Core
Scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, with direct responsibility for clinical deliverables for one or more studies.
Role type
Director, Clinical Development Scientist (Non-MD)
Builds
Clinical trials for biopharmaceutical products
Domain
Biopharmaceuticals, Internal Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
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, clinical study report review
Preferred skills
Cardiometabolic disease experience, scientific productivity via publications, extensive knowledge of ICH/GCP, clinical administrative and project management capabilities, team leadership and mentorship
Technologies
None stated
Responsibilities
Lead clinical execution of studies, develop protocols and amendments, provide clinical guidance on data collection and safety plans, manage external committees, ensure TMF compliance, support audits and inspections, contribute to regulatory filings
Seniority
Director, hands-on IC with managerial responsibility
