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,
What Youll Do Review scope of project and resourcing related to Clinical Monitoring with Clinical Project Management Plan, schedule, and implement the clinical monitoring aspects of projects Define and implement project-specific functional standards, goals, and expectations
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,