ZILI LI, MD, MPH
HEAD OF ASIA PACIFIC R&D
JANSSEN RESEARCH & DEVELOPMENT
As Head of Asia Pacific R&D, Zili oversees all R&D activities within Asia Pacific, leading over 1,400 science professionals dedicated to delivering transformational healthcare innovation across the region.
Zili joined Janssen in June 2019 from the U.S. Food and Drug Administration (FDA) where he served as Associate Director for Global Affairs at the Office of Generic Drugs. There he contributed significantly to the expansion of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to the field of generic drugs, playing a critical role in China’s National Medical Products Administration’s membership in ICH in 2017.
Before rejoining the FDA in 2015, Zili had over 10 years of leadership and program management experience in pharmaceutical R&D at both Merck and the Bill and Melinda Gates Foundations, where he built high-performance and science-driven organizations and drove substantial increases in R&D productivity. At Merck, he served in positions of increasing responsibility in clinical development and regulatory affairs at global, regional and local levels. His roles included Medical Director of MSD China, Head of China and Asia Pacific Regulatory Policy, and Executive Director and Head of Emerging Markets Regulatory Strategy. At the Bill & Melinda Gates Foundation, Zili served as Deputy Director and Head of China R&D.
Zili first joined the FDA in 2000 as a medical reviewer for drug safety. Later he was promoted to medical team leader for overseeing IND and NDA reviews in defined therapeutic areas. In addition, Zili participated in FDA guidance development for the industry and presented at the FDA’s advisory committee meeting on behalf of the agency. Zili was a recipient of numerous FDA awards, including 2003 FDA Scientific Achievement Award and 2014 FDA Distinguished Alumni Award.
Zili is a graduate of Peking Union Medical College and completed his residency training at Johns Hopkins in 2000. In addition to his medical degree, Zili also holds two master’s degrees in public health.