Supporting and overseeing the R&D team while building capabilities for investigating the biological and clinical significance of a novel class of biomarkers in oncology, gangliosides. We are focused on specific ganglioside markers in ovarian cancer, as we build our diagnostic platform with the goal of detecting cancer early in women. We are also characterizing gangliosides in other cancer types to expand our diagnostic platform.

Directing and supporting cross-functional teams developing MCED (multi-cancer early detection), an innovative product for the early detection of cancer.

Recruited to build cross-functional departments and IVD capability for a startup diagnostics company. Drove the establishment of Research & Product Development, Regulatory, Quality, Project Management, Clinical Affairs, Manufacturing and Design Transfer, Data Management and Biostatistics, and Bioinformatics for commercialization of PGDx technologies domestically and internationally.

Oversaw Assay and Reagent Development Organization at Ventana Medical Systems (Roche Tissue Diagnostics). Includes Reagent Development, Antibody Development, Assay Transfer, Companion Diagnostics Development, Molecular Probes and Detection, and Cytology.

Established Companion Diagnostics Program business unit that led to >20 of pharmaceutical co-development deals and 4 PMA submissions, and additional PMA supplements (platform migrations and label expansions). Oversaw teams to support global clinical trials and resulting PMA submissions.

Developed fully automated HER2 Dual ISH assay for PMA submission: FDA approved June of 2011, with platform migration PMA supplement in April 2012.