Analyze results, interprets, and recommends action based on study results.Lead clinical pharmacology efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions.Work with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.Provide key components of the Early Development Plan, advises teams on Clinical Pharmacology Strategy and science and provides input to line management.Drive the development and execution of the Clinical Pharmacology Strategy and Plan of several clinical development and/or program teams.You will also serve as a manager/mentor to less experienced staff and as a Clinical Pharmacology resource within the function and across the company. You will provide rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. As the Director of Clinical Pharmacology, you will serve as the clinical pharmacology lead on several clinical development or program teams providing strategic leadership and execution of clinical development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas.
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