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,
Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation