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, study design,
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,
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 (ICH)