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Job Purpose/ Summary: Independently manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with,
Job Purpose/ Summary: The Director, Model Informed Drug Development/ Consulting is a senior individual contributor responsible for leading modeling and simulation activities within drug development programs. The incumbent applies advanced pharmacometric methodologies to support dose selection,
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