Andy Lee

Andy Lee is a recently retired biopharmaceutical executive with over 30 years of experience in leading research-intensive clinical operations. Most recently, he served as Senior Vice-President and Head of Global Clinical Trials Operations at Merck Research Laboratories in Rahway, NJ. During his tenure at Merck, he led a global team of 12,000 professionals, managing clinical trials across more than 60 countries and overseeing over 100,000 trial participants in approximately 300 protocols. He played a pivotal role in the operational execution of Keytruda, a groundbreaking cancer treatment that has become the largest-selling biopharmaceutical product worldwide.

Andy began his career at Pfizer in South Africa, where he managed local clinical trials. He later moved to Pfizer’s Research Headquarters in Groton, CT, taking on various clinical development roles, including team leadership in both early-stage and late-stage development. In 2009, he joined Genzyme in Boston, focusing on biologics and rare diseases, and led the integration of clinical operations following Genzyme’s acquisition by Sanofi in 2011.

A pioneer in expanding clinical trial operations, Andy conducted the first global studies in Egypt and South Korea and was involved in Japan’s first-ever inclusion in a Western phase 3 trial. He is a founding member and has served as Treasurer of TransCelerate Biopharma, where he co-led the Quality Management workstream to enhance quality management systems across the industry.

Currently, Andy is focused on Human Research Subject Protection, working towards AAHRPP accreditation for Merck and its affiliates, as well as mentoring diverse youth and building capacity in under-resourced regions. He collaborates with the Gates Foundation to strengthen clinical research capacity in Africa through the African Clinical Research Network (ACRN). While at Merck, he has been a Sponsor member of the Brigham and Women’s Hospital and Harvard MRCT Center.

Andy holds a BA Hons from Rhodes University in South Africa and a Master’s degree from Ball State University, awarded through a Fulbright Scholarship. He is a certified ACRP Clinical Professional. Outside of his professional pursuits, he enjoys nature, gardening, and triathlons. He resides in Old Lyme, CT, with his wife, Jean Lee, a former head of portfolio and project management at a large biopharma company, and they have two grown daughters, one a doctor and the other an engineer.