The Executive Director, Clinical Leader (CL) is responsible for development and execution of medical and scientific strategies for late phase compounds (Ph2b/3), and operational implementation, delivered through the effective leadership of a cross-functional Clinical Team (CT). The CL leads the team to develop products in a timely and cost-effective manner and is responsible for the clinical development plans (including life-cycle management, geographic expansion, and post-marketing commitments), protocol development, quality execution of clinical studies, preparation and ownership of clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are project physicians. Team leadership via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, data management, medical writing, biostatistics, global medical safety, pharmacogenomics, early clinical development, clinical pharmacology, data science, digital health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.
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