Medical Director, CVM

Role Overview

• Participates in development of the CD plan for assigned molecule(s)/indication(s)
• Gathers and analyzes data and information necessary to create the CD plan
• Works with other CST members and relevant sub-teams to develop CD plan components
• Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s)
• Collaborates with a variety of internal and external partners and stakeholders
• May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance
• Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies, including providing CD input for MA study protocol development
• Participates in design, development, and execution of clinical studies
• Collaborates with others in the development of product safety profiles
• Includes reviewing and providing late stage input into Phase I and II protocols
• Supports other CST members to ensure correct medical/scientific data interpretation for interim and final study reporting
• Acts as a medical monitor for assigned studies
• Participates as standing or ad hoc member of sub-teams relevant to assigned molecule(s)/indication(s)

Requirements

• Academic/Scientific/Clinical: M.D. Required
• Therapeutic knowledge within metabolism, obesity, and diabetes with relevant clinical, scientific, and clinical trial/development experience required
• Academic/teaching background is a plus
• Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance
• Experience publishing results of a scientific study in a peer-reviewed journal is preferred
• Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is preferred
• 2 or more years of post-graduate academic or clinical experience
• Up to 30% global travel

Tech Stack

• Google Cloud Platform