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Senior Director Regulatory RWE & Epidemiology
MedTech Epidemiology & Real-World Data Sciences, Johnson & Johnson, United States
Shumin Zhang, MD, ScD, is Senior Director Regulatory Real-World Evidence (RWE) & Epidemiology and Regulatory and Oncology Team Lead within the Johnson & Johnson MedTech Epidemiology & Real-World Data Sciences. In this role, Shumin is responsible for leading the design, execution, and delivery of RWE studies for regulatory approvals for all Johnson & Johnson MedTech business units. She also leads the MedTech Epidemiology & Real-World Data Sciences scientific partnership with Interventional Oncology at Johnson & Johnson. Shumin has played a leadership role in conducting the FDA-funded National Evaluation System for health Technology (NEST) RWE test cases of Johnson & Johnson products for label expansions and active safety surveillance. She currently serves on the NEST Research Methods Subcommittee developing RWE research methods framework for medical device evaluations. The RWE studies that she led have resulted in 4 FDA label expansion approvals and clearances for 9 Johnson & Johnson cardiac ablation and mapping devices. Shumin has over 20 years’ experience in the MedTech and pharmaceutical industries and academia. Prior to joining industry, she was an Associate Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School, where she served as the Principal Investigator of multiple grants funded by the NIH/NCI and American Cancer Society. Shumin received her Doctor of Science degree in Epidemiology from Harvard University, her medical degree from Harbin Medical University, and her master's degree from the Chinese Academy of Preventive Medicine. Shumin has authored or co-authored more than 140 scientific papers in peer-reviewed journals, including JAMA and New England Journal of Medicine.
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Tuesday, August 27, 2024
2:20 PM – 2:25 PM CEST