Disruptive Innovations US Speakers

Andrew Lee, MD

SVP, Head of Global Clinical Trial Operations

Merck

Andy Lee is the Deputy Head of Clinical Sciences and Operations at Sanofi. He is responsible for the execution of clinical trials, across diverse phases and therapeutic areas, around the world to deliver clinical trials to high-quality international GCP and regulatory standards in a timely and cost effective manner.

Andy has ~20 years industry experience conducting clinical studies ranging from pre-clinical to phase IV drug development, across multiple platforms such as devices, small molecules, biologics and gene-therapies.  He started his career at Pfizer, managing a clinical research department in South Africa. During this time he gained experience in conducting trials in a wide variety of therapeutic areas.

Andy moved to the United States in 1996 to work as a Clinician in the Cardiovascular and Metabolic Diseases group. Since then he has chaired an Early Candidate Management Team from First in Human to phase III development, been a Local and Global Clinical Leader. His passion has been for conducting large global trials as evidenced by his experience with a 37-country breast cancer study and as the Global Protocol Leader for an 8,500-subject, 32-country protocol in postmenopausal women at risk for osteoporotic fractures, cardiovascular disease, and breast cancer. He has undergone numerous regulatory sponsor/monitor inspections as well as site and vendor inspections following MAA/NDA filings.  Since 2005, Andy has focused his efforts on Clinical and Development Operations at Pfizer, where he held a variety of Leadership positions as the WW Head of Clinical Study and Data Management, the WW Head of Clinical Study Operations, the Global Head of Clinical Project Management and Clinical Quality Management.  Andy moved to Genzyme in 2009 where he was the Head of Global Clinical Operations prior to the Sanofi acquisition of Genzyme.

Andy is interested in Human Subject Protection, Multiregional Studies, Quality and Compliance, Operational Excellence and finding more efficient ways to run clinical trials. At Sanofi he Sponsors the Innovation team in Clinical Operations.

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