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Distinguished Scientist, Clinical Research, Thoracic Malignancies

Merck · Rahway, New Jersey, United States

Full-time Posted 4 days ago

About this role

<p style="text-align:left"><b>Job Description</b></p><p style="text-align:inherit"></p><p>Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. </p><p></p><p>The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.</p><p></p><p>The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting

They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. </p><p></p><p>Specifically, the Executive Director, PDT Lead may be responsible for: </p><ul><li><p>Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications. </p></li><li><p>Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.</p></li><li><p>Planning clinical trials (design, operational plans, settings) based on these clinical development strategies </p></li><li><p>Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents</p></li><li><p>Analyzing and summarizing the clinical findi

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