Leads the development and implementation of the Model-Informed Drug Development (MIDD) strategy for drugs and other therapeutic agents in clinical development, in partnership with Clinical Pharmacology and other quantitative functions. The role places quantitative evidence at the center of development and regulatory decision-making. MIDD integrates diverse data through pharmacometric models to inform development decisions and regulatory assessments. Model-Based Meta-Analysis provides quantitative assessment of competitors and comparators to refine asset strategy. MIDD informs dose and regimen selection, clinical study hypotheses, and the clinical data package supporting regulatory assessment of clinical pharmacology and benefit-risk. Pharmacometric analyses may also influence regulatory approval decisions and, in some cases, serve as a primary basis for approval.
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Job Type
Full-time
Career Level
Senior