Genomic Health, Inc. is an oncology-based health care services company providing individualized genomic analysis of tumor biopsies. Management responsibilities include supervision of a group of 40 statisticians and data managers with direct reporting relationship to the EVP Research & Development. Clinical responsibilities include oversight of biostatistical and data management activities related to the design, analysis, and regulatory submission of large-scale oncology trials in support of the development of pharmacogenomic tests and predictive algorithms. Non-clinical activities include the development, validation and commercialization of high-throughput assays utilizing RNA extracted from fixed paraffin embedded tissues.
Founder and CEO of a computational biology company aimed at lead drug discovery and quality control of high-throughput biological systems. Raised $1.6M in Series A financing from investors including Accenture Venture Capital, Mobius Venture Capital (formerly Softbank Venture Capital), GameChange LLC, and Evercore. Acted as Chief Scientific Officer responsible for the scientific development of the Company’s primary products including
Qualifier™ - a quality/performance management system for high-throughput biological systems.
Curator™ - a biological text mining solution for drug discovery.
Predictor™ - a lead discovery platform that utilizes both proprietary numerical, structural and semantic (text) data to predict key characteristics of lead compounds.
As General Manager, provided leadership, vision, strategic direction and operational excellence in running a division of 150 employees involved in the commercialization of gene and protein expression technologies. Also responsible for corporate development activities including strategic and business management, technology assessment, licensing, intellectual property, and M&A activities. Handled staffing, planning, operations, marketing and customer support activities with direct P&L responsibility for a $20M organization. As VP of Quantitative Biology provided guidance in the development of statistical, bioinformatics and quantitative methods for target identification and the analysis of genomic sequence and expression data.
Managed a biostatistical and data management department responsible for providing leadership in the discovery, development, manufacture and marketing of biopharmaceutical products including vaccines, therapeutics and molecular diagnostic devices. Clinical support responsibilities at Chiron included overseeing statistical and clinical data management activities and personnel as well as development of analysis plans, study workbooks and summary reports for the successful submission of FDA IND, NDA, 510(k) and PMA applications. Non-clinical responsibilities involved providing biostatistical support to drug discovery, computational chemistry, bioinformatics, clinical research, assay development, process development, pharmacology, manufacturing, regulatory affairs, marketing, corporate compliance and quality assurance.
Provided management and statistical expertise for pharmaceutical research activities. Instrumental in the establishment of an Experimental Statistics Department responsible for R&D, pharmaceutical research, clinical development, pharmacology and assay development activities. Responsibilities included the application of statistical experimental design, optimization, robustness, reliability and statistical quality control methods for process improvement.
Founder and principal management consultant for Process Plus Inc. - a management consulting firm. Obtained over ten years’ management experience under the guidance of the late late Dr. W. Edwards Deming - “Father of the Japanese Industrial Revolution.” Consulted to industries as diverse as aerospace, biotechnology, electronics, biopharmaceutical and health care. Clients included Hewlett-Packard (nine divisions), Dow Chemical, Applied Materials, NEC, Intel, 3-Com, Siltec, Printed Circuit Builders, Computer Products Inc., Connector Technology Inc., Conejo Circuits and Armstrong World Industries.
Provided management and statistical support to nine divisions, including the printed circuit and personal computer divisions. Supported several other divisions, including the HP-3000, instrumentation and medical products divisions. Introduced Hewlett-Packard's first quality improvement program based on the philosophies of Dr. W. Edwards Deming. Implemented Hewlett-Packards first just-in-time manufacturing system.