Senior Global Development Medical Director
Core
Provide clinical and scientific leadership across global development programs in Cardiovascular, Renal and Metabolic Diseases (CVRM) to advance medicines through development.
Role type
Senior Global Development Medical Director
Builds
Clinical studies, protocols, safety plans, and clinical study reports for CVRM medicines
Domain
Pharmaceutical R&D, Cardiovascular, Renal, and Metabolic Diseases
Required skills
Study design, protocol development, clinical trial safety, GCP, pharmacovigilance, biostatistics, regulatory requirements, data interpretation
Preferred skills
Nephrology, cardiology, chronic kidney disease, diabetes, obesity, metabolic disease, NASH, MASH, Phase IIb/III/IV studies, regulatory submissions, commercial medical strategies
Technologies
Clinical trial management systems, statistical analysis software
Responsibilities
Lead study design concepts and establish objectives for clinical programs; Provide medical expertise to Product Teams and interpret clinical/safety data; Deliver medical information to regulatory authorities and investigators; Oversee study-level safety surveillance and adverse event reporting; Prepare and approve Clinical Study Reports; Identify study risks and propose mitigation strategies
Seniority
Senior, hands-on IC