Vice President, Global Clinical Pharmacology
ADC Therapeutics
Dr. Guoxiang George Shen is a highly experienced clinical pharmacologist with 20 years of expertise in both pharmaceutical industry and regulatory environments, including the U.S. Food and Drug Administration (FDA). Throughout his career, Dr. Shen has played a pivotal role in early and late-stage clinical development of novel anti-cancer therapies, as well as review and approval of numerous therapeutic agents across various therapeutic areas, including oncology, immunology and hematology diseases.
Dr. Shen began his career at Bristol-Myers Squibb, where he gained extensive experience in drug discovery, DMPK and PK/PD modeling and human dose projection. He then joined Novartis Oncology where he led clinical pharmacology studies to support NDA submission and life-cycle management of multiple drugs.
After transition to FDA in 2015, Dr. Shen served as a Senior Clinical Pharmacology reviewer in the Division of Cancer Pharmacology. In this capacity, he evaluated more than 500 of Investigational New Drug (IND) applications and associated various meeting packages, as well as many NDA and original BLA submissions, providing critical guidance to industry sponsors and academic investigators on Clinical Pharmacology regulatory requirements, clinical trial design and dose optimization strategies.
In 2022, Dr. Shen returned to industry and joined BioAtla Inc. as Head of Clinical Pharmacology. In this role, he led the clinical development including IND filing, clinical trial design and dose optimization efforts of anti-cancer biologics including ADCs, monoclonal antibody and T-cell dependent bispecifics.
Dr. Shen joined ADC Therapeutics in 2024 as the Vice President, Global Clinical Pharmacology. He leads the Clinical Pharmacology team to support the clinical development of multiple ADC drugs including Zynlonta.
In addition to his regulatory and industry experience, Dr. Shen has authored numerous peer-reviewed publications and presented at international conferences.
Dr. Shen holds a Ph.D. in Pharmaceutical Science from Rutgers, The State University of New Jersey.
