Directing companion diagnostic development to support therapeutic pipeline. Including the regulatory strategy, establishment of a CLIA and IVD development laboratory in a pharmaceutical/diagnostic company. Developed clinical trial assay currently supporting a global phase 2 trial.• Built and led diagnostic organization within company, including groups in charge of diagnostic assay development, clinical laboratory testing and business operations. • Led data generation and analysis for regulatory submissions for the clinical trial assay, Trailblaze Pharos, resulting in an IDE from the FDA, Expedited Access Pathway (EAP) designation and CE-marking for ex-US/EU testing. The design also encompasses other assets in the company pipeline.• Evaluated new technologies and platforms for future opportunities aligned with corporate goals.• Design and establish pharmacodynamic assays for pre-clinical and early clinical testing of pipeline candidates. • Global outreach and support to identify clinical trial sites and maintain engagement and facilitate local testing.

Headed up assay development activities and new technology translation in support of clinical laboratory operations. Translating technology platforms from development to clinical grade, including next generation sequencing, digital pathology and high sensitivity molecular testing.• Introduced quantitative immunohistochemistry tests in the clinical laboratory using a new technology platform encompassing laboratory work, hardware, software and interpretive components. Developed a breast marker panel and recurrence score (IHC4) based on this proprietary technology.• Led efforts to develop next generation sequencing (NGS) based diagnostic tests (melanoma, MDS, AML). Employed deep sequencing to identify somatic mutations: introduced the first tests of this kind to be fully reimbursable and one of the first to achieve full NYSDOH approval. • Implemented appropriate assay validation methods and statistical rigor.

Led development and commercialization of company’s proprietary technology platform (fluorescent IHC analysis system adjunctive to digital pathology) for biomarker studies in clinical pathology and oncology applications which enabled better patient care through more personalized medicine.

Directed the team responsible for transferring scientific protocols and diagnostic applications to the company’s state-of-the-art automation platform. Assisted customers and partners by providing complete automation solutions to laboratory processes which helped overcome challenges of scale, adaptation of manual processes and workflow.

Participated in development and commercialization of a protein microarray platform using rolling-circle amplification (RCA) technology applied to multiplexed immunoassays. Challenges included developing improved manufacturing, metrics for qualification of new markers and improving analytical methods for biomarker(s) discovery.