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Senior Principal Scientist, Clinical Research, Immunology

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>The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.</p><p></p><p><b>Specifically, The Senior Director May Be Responsible For:</b></p><p>• Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.</p><p>• Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline</p><p>• Developing clinical development strategies for investigational drugs and planning clinical trials (design, operational plans, settings) based on these clinical development strategies.</p><p>• Monitoring and managing the conduct of ongoing or new clinical trials for investigational drugs.</p><p>• Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; and</p><p>• Participation in internal and joint internal/external research project teams relevant to the development of new compounds</p><p></p><p><b>The Senior Director may:</b></p><p>Supervise the activities of Clinical Scientists in the execution of clinical studies

Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director in ensuring that appropriate corporate personnel are informed of the

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