Robert Metcalf

Vice President, Clinical Development Organization, Eli Lilly and Company


Robert is currently the Vice President of the Clinical Development Organization. In this role, Robert has responsibility for worldwide delivery of clinical research across all therapeutic areas and phases of clinical development. He is also responsible for Lilly’s Biometrics and Advanced Analytics organization, which provides Research and Development with leading capabilities in data, information, and analytics.

After completing his Ph.D. in Pharmacology and Toxicology at Queen’s University in Canada, Robert joined Eli Lilly Canada in the Regulatory Affairs organization where he led successful approval efforts, for neuroscience and anti-infective new chemical entities. His next opportunity led him to the Lilly Corporate Center in Indianapolis where, as a member of the Global Project Management organization, he led cross-functional teams in the global development and registration of new molecular entities in Lilly’s diabetes and osteoporosis portfolios. Following this opportunity, Robert returned to Lilly Canada where he had leadership responsibility for Regulatory Affairs, Health Outcomes, and Quality. In 1998, Robert was transferred to Japan where he led the Project Management and Pharmaceutical Development organizations for Lilly Research Laboratories, Japan. After 4 years in Japan, Robert returned to the Lilly Corporate Center in Indianapolis as a Director in Project Management with responsibility for the Project Management organizations supporting early and late stage drug development.

In 2005, Robert was named Executive Director, Global Patient Safety with worldwide responsibility for adverse event case management, pharmacovigilance, and quality systems in support of product safety. In June of 2009, Robert was name Vice President, Global Ethics and Compliance where he had responsibility for providing Ethics and Compliance leadership to functional and geographic areas across Eli Lilly, included implementation of an effective compliance program. In February of 2011, Robert was named Vice President Global Regulatory Affairs-North America, with responsibility for leading Lilly’s interactions with the FDA, including submissions, review, and approvals, as well as representing industry in engagement with the FDA on key policy topics, including negotiation of user fee agreements (specifically PDUFA VI). In February 2017, Robert was named Vice President, Medicines Development Unit for Diabetes and Clinical Transformation with responsibility for clinical development supporting Lilly’s Diabetes portfolio and for efforts supporting continuous improvement of global clinical development across all therapeutic areas. In March 2018, Robert moved into his current role of Vice President of the Clinical Development Organization.