Jun Shi, MD, is President of G2C Consulting and an independent researcher based in San Francisco, USA. From May 2019 to May 2024, he served in executive roles (CMO, CDO) at a biotech company and a CRO in Shanghai, China. Prior to that, from October 2011 to May 2019, he led Early Clinical Development and Clinical Pharmacology at Roche Innovation Center Shanghai. From 1991 to 2011, he accumulated 20 years of experience at global pharmaceutical companies in the United States, holding functional leadership positions at Berlex, Aventis, Forest Laboratories, Daiichi Sankyo, and Allergan. Dr. Shi received his medical education and training in Clinical Pharmacology from Shanghai Medical University and later from the University of California, San Francisco. His research interests focus on innovative clinical trial designs to accelerate development timelines and optimize dose regimens. He has firsthand experience implementing model-informed drug development (MIDD) strategies across multiple therapeutic areas, including oncology, infectious diseases, ophthalmology, and cardiovascular and metabolic diseases. Dr. Shi is a Fellow of the American College of Clinical Pharmacology (FCCP) and a member of the American Society for Clinical Pharmacology and Therapeutics. Since 2006, he has actively promoted clinical development science in China. He serves as a Standing Member of the Editorial Board for the Chinese Journal of Clinical Pharmacology and Therapeutics and a member of the Chinese Society of Quantitative Pharmacology. He is an editor of the book Quantitative Pharmacology and New Drug Evaluation and served as the inaugural Chair of the International Symposium on Quantitative Pharmacology in Drug Development and Regulation. He was Co-Director of the Clinical Pharmacology Fellowship Programs jointly established by Roche with Peking Union Medical College and with Shanghai Huashan Hospital. He is an Adjunct Professor at the Clinical Research Institute of Peking University and at Huashan Hospital, Fudan University. He also chairs the Early Clinical Development module of CCDRS and YeeHong. Dr. Shi served as a member of the ICH E11A Expert Working Group and as a panel member for two antibiotic guidelines at the Center for Drug Evaluation (CDE), National Medical Products Administration (NMPA) of China.