• Serves as a source of medical expertise for clinical project teams • Provides input to decisions that have medical, scientific, and future marketing implications • Provides medical input into the design, planning, initiation and completion of clinical trials • Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions • Serves as the medical monitor for the successful conduct, integrity, and safety of patients in our clinical trials • Partner with Research, Regulatory Affairs, Medical Affairs, Biometrics, Clinical Operations, Safety, Quality Assurance, Product Development, Business Development, and Management to formulate and implement comprehensive clinical trial plans • Establishes communications and relationships with prominent clinical investigators in the area of cardiovascular disease • Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events • Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with key opinion leaders • Performs product safety medical reviews for assigned investigational drugs • Ensures an appropriate level of customer service to internal and external customers