Associate Director, Clinical Science
Core
Associate Director leading clinical science for therapeutic compound development, supporting study design, protocol execution, regulatory filings, and clinical data/safety review.
Role type
Senior IC clinical science lead
Builds
Clinical development strategies and regulatory submissions for therapeutic compounds
Domain
Biopharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
clinical study design, protocol development, regulatory document preparation, clinical data review strategy, safety data analysis, site selection, investigator training, TMF compliance, clinical study reporting
Preferred skills
therapeutic area expertise, statistical analysis plan input, risk management planning, external committee collaboration
Technologies
Clinical Trial Management Systems, Electronic Data Capture, Regulatory Submission Platforms
Responsibilities
Maintain scientific knowledge in assigned therapeutic areas; contribute to protocol design and amendments; develop informed consent documents; provide clinical input to statistical analysis plans; lead clinical data review and query resolution; collaborate on safety review plans and narratives; support risk management plans; establish external data monitoring committees; select sites and deliver protocol training; serve as primary clinical contact for investigators; manage protocol deviation reporting and trends; ensure TMF compliance; review Clinical Study Reports
Seniority
Senior, hands-on IC
