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Executive Director, Product Development Team Leader, Clinical Research, Hematology - Lymphoma

Merck · Rahway, New Jersey, United States

About this role

<p style="text-align:left"><b>Job Description</b></p><p style="text-align:inherit"></p><p>The Executive Director (Distinguished Scientist) and Product Development Team (PDT) lead has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Oncology therapeutic area, Hematology section.</p><p></p><p>The Executive Director will manage and oversee the entire cycle of late-stage clinical development from Phase 2 to Phase 5, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key scientific leaders.</p><p></p><p>The Executive Director may be responsible for:</p><ul><li><p>Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug (IND) applications</p></li><li><p>Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations</p></li><li><p>Executing the clinical strategy, planning clinical trials (design, operational plans, settings), and leading the clinical subteam</p></li><li><p>Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines</p></li><li><p>Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines</p></li><li><p>Acting as an integration of cross-functional input and expertise, ensuring all perspectives are incorporated into the strategy/

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