Oversaw cutting-edge research & development efforts with responsibility for conceptualizing and designing revolutionary Next Generation Sequencing (NGS) and qPCR tests.Cultivated relationships with top molecular pathology laboratories and scientists to understand research goals, develop solutions, integrate new technology, and validate design, performance, and regulatory claims of tests. Compiled and prioritized lists of genes to provide vital information to clients. Managed laboratory… Show more Oversaw cutting-edge research & development efforts with responsibility for conceptualizing and designing revolutionary Next Generation Sequencing (NGS) and qPCR tests.Cultivated relationships with top molecular pathology laboratories and scientists to understand research goals, develop solutions, integrate new technology, and validate design, performance, and regulatory claims of tests. Compiled and prioritized lists of genes to provide vital information to clients. Managed laboratory technicians; assisted in resolving bench-level science issues.Selected Contributions:♦ Succeeded in designing four NGS oncology tests, created control reference material, and drafted submission to FDA to obtain premarket approval (PMA) for a Companion Diagnostic (CDx). Show less

Led start-up operations and financial performance for CLIA-certified and CAP-accredited laboratory developing groundbreaking oncology tests.Interfaced with laboratory director, technicians, and business colleagues to design and develop tests meeting strict regulatory requirements. Seeded databases and prepared documentation. Recruited, hired, and integrated 20-member team. Managed relationships with vendors and procured equipment. Oversaw all marketing efforts to promote lab and tests… Show more Led start-up operations and financial performance for CLIA-certified and CAP-accredited laboratory developing groundbreaking oncology tests.Interfaced with laboratory director, technicians, and business colleagues to design and develop tests meeting strict regulatory requirements. Seeded databases and prepared documentation. Recruited, hired, and integrated 20-member team. Managed relationships with vendors and procured equipment. Oversaw all marketing efforts to promote lab and tests. Tracked financial and sales data to adjust marketing strategies, reimbursement structure, and staffing as needed.Selected Contributions:♦ Developed and marketed 140 LDT cancer tests within first year and offered groundbreaking NGS oncology panel test in the United States under LDT/CLIA/CAP.♦ Provided effective leadership to enable laboratory to break even within two years with $5M in business. Show less

Led development of $25M market in cytogenetics converting karyotype into microarrays and navigated complex FDA/LDT requirements to market and sell to cytogenetic labs.Engaged with cytogenetic laboratories to evaluate products, prepared product technical notes, and oversaw demonstration laboratory. Directed clinical research collaborations with top universities. Coached sales team on products, clinical diagnostics, sales pitches, and FDA/CLIA compliance issues. Maintained and operated… Show more Led development of $25M market in cytogenetics converting karyotype into microarrays and navigated complex FDA/LDT requirements to market and sell to cytogenetic labs.Engaged with cytogenetic laboratories to evaluate products, prepared product technical notes, and oversaw demonstration laboratory. Directed clinical research collaborations with top universities. Coached sales team on products, clinical diagnostics, sales pitches, and FDA/CLIA compliance issues. Maintained and operated laboratory equipment. Documented and published new techniques. Received two University Relations Grants.Selected Contributions:♦ Pioneered entry into clinical diagnostics, demonstrated value proposition, and gained full support from leadership team.♦ Initiated and led development and launch of eArray Web site and CytoGenomics software still in use and profitable today.♦ Successfully grew market by 25% year-over-year for four years; led development of 50+ clinical arrays, introduced 11 RUO products/reagents, and managed royalty payments on two color array CGH for clinical applications.♦ Spearheaded innovative marketing strategies, including “RockStar” Marketing Program for clinical cytogeneticists to share array content under LDT.♦ Served as relationship manager and coordinator for International Standard Cytogenetic Array Consortium (ISCA), Cancer Cytogenomics Microarray Consortium (CCMC), NIH/Columbia Prenatal Multi-Center Array Grant, and Agendia, BV and Agendia, Inc.♦ Received distinction as Invited Chairman and Speaker at BIT’s 1st Annual Congress and Expo of Molecular Diagnostics (10/08).♦ Held contracted positions as Product and Marketing Manager for Diagnostics (5/06-10/06) and Outbound Marketing Consultant (1/05-5/06). Show less

• Phone/Email Technical Support of RNA Amplification Product (Ribo-SPIA)• Weekly Field Pre-Sales/Technical Seminars and Talks. WebEx Seminars

• Provided customers with onsite training and support on microarray technologies (pin-spotter, laser scanner and software)• Assisted with system end-to-end testing, representing customer’s point of view in Marketing• Member of the PDP (Product Development Process) team. Providing scientific user requirements input into future products