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Medical Director Clinical Lead Dermatology
5 months ago
· Provides guidance to Clinical Study Teams to ensure alignment of clinical trials planning and conduct with the overall development strategy.
· Review and approves (when applicable) key clinical trial documents (e.g. protocol, SAP, CSR).
· Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP
· Ensure internal and external peer review of potential study/program design.
· Responsible for clinical content for key internal or external project related documents (eg. IB, briefing package for regulatory authorities, ISE, ISS, publication).