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Areas of expertise: Clinical Development; Protocol Development, phases 1-4: small molecules, drug-device, biologics; Clinical Operations; Patient Safety; Medical Affairs; Global Regulatory Interactions; Team Building; Strategic Planning; Corporate Governance
Michelle is an executive leader with over 20 years’ experience in clinical drug development and medical affairs and expertise in cardiovascular, endocrinology and metabolic diseases. She has a track record of building and leading high performing cross-functional teams responsible for executing clinical development programs across therapeutic areas and geographies; integrated Medical Affairs plans and field based medical activities. Michelle fosters a culture of teamwork, open communication and collaboration that enables timely and creative problem-solving and effective decision making on multidisciplinary issues within complex organizations. She maintains strong peer relationships with investigators and academic thought leaders.
As a consultant, Michelle has served as acting Chief Medical Officer for multiple early phase biotech companies ensuring compliance with regulatory, legislative, GCP requirements and Corporate governance. She also serves as senior medical reviewer for Medical/Clinical and Promotional Review committees. Michelle provides strategic input into, and management of clinical development programs, protocol design, clinical operations, medical affairs, patient safety, interactions with FDA/regulatory agencies and development of key regulatory strategies and documents.
As Chief Medical Officer at Intarcia Therapeutics, Inc., Michelle led the Development Committee responsible for executive strategic planning across all functions of the organization and the Clinical Research organization responsible for the design and execution of the global Phase 3 clinical program and NDA filing for the Company’s lead asset, ITCA 650. She developed and maintained relationships with academic institutions and key opinion leaders for the purposes of research collaboration.
Michelle was VP of the Metabolism Medical Unit at sanofi-aventis US responsible for the company’s US insulin portfolio and VP, Diabetes US, responsible for the design and execution of the US Diabetes Patient Solutions platform, the assessment of business development opportunities and strategic partnerships for the US Diabetes Division.
At Novartis, Michelle led the Diabetes Section within the US CVM Clinical Development and Medical Affairs group. Her team was responsible for the planning, execution, and monitoring of Phase 2-4 clinical trials. Michelle also served as a core member of clinical development, registration and commercialization teams for cardiovascular and diabetes development products.
Michelle is board-certified in Internal Medicine and Endocrinology and Metabolism and is a Fellow of the American College of Endocrinology. She earned her BA in biology from Johns Hopkins University and her MD from Howard University College of Medicine. She did her postgraduate training in Internal Medicine at Emory University and her Endocrinology fellowship at the State University of New York Health Science Center at Brooklyn. Michelle served four years in the National Health Service Corps. She is an Assistant Professor of Medicine at SUNY and maintains a clinical appointment at the University Hospital of Brooklyn. Michelle is currently pursuing a master’s degree in theology at Seton Hall University.