Dedicated and accomplished biotechnology professional with 20+ years of experience in translational and clinical oncology research & development including strategic biomarker and diagnostic development in drug development, both early and late phase oncology. One plus years direct regulatory experience at the Food and Drug Administration (FDA) including leading reviews for companion diagnostic products as well as developing regulatory guidance and policy. Additionally, have 10+ years of experience in scientific group management and laboratory operations. Expertise in digital and computational pathology, image analysis through AI and deep learning, immunohistochemistry, quantitative immunofluorescence and assay development with experience in advanced statistical analysis; advanced molecular diagnostic technologies including next-generation sequencing (NGS), quantitative PCR, and circulating tumor cell and DNA technologies.Specialties: Biomarker diagnostic research clinical development; CLIA laboratory development and operations; assay development; biomarker translational and clinical research; diagnostic assay and platform development; digital pathology and image analysis (deep learning and AI); immunohistochemistry; fluorescence; molecular methods including qPCR, FISH/ISH and next-generation sequencing (NGS); analytical methods development; advanced statistical analysis; cellular and molecular biology; FDA submissions. Medical Science Liaison as well as sales training and support.