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Head of Global Regulatory Affairs, Biomarkers & Diagnostics at Merck, Germany
Dr. Claudia Dollins is the current Head, Global Regulatory Affairs, Biomarkers & Diagnostics at Merck KGaA. As such, she is responsible for the development and implementation of global regulatory strategies to enable the development of biomarkers and companion diagnostics in the Merck KGaA pipeline. Prior to joining Merck in 2015, Dr. Dollins served as a senior reviewer and acting chief of the hematology branch of the Office of In Vitro Diagnostics and Radiologic Health at the FDA. During her tenure at FDA, she has gained broad regulatory experience in the review of complex in vitro diagnostic devices, to include companion diagnostics and point of care devices. She further served as the FDA representative in numerous inter-office, inter-center, and outside FDA committees.
Dr. Dollins received a PhD in Genetics and Genomics from Duke University Medical Center prior to postdoctoral training in Developmental Biology at the University of North Carolina, Chapel Hill.