• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts • Provides medical input into data collection tools, monitoring plans, and review and analysis plans • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues • Provides after-hours medical coverage for clinical studies • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines