Provides executive leadership and strategic direction for Provista Diagnostics focused on developing liquid biopsy-based diagnostics to detect early-stage cancers. Responsibilities include clinical, laboratory and business operations (client services), clinical product development, IT/Informatics and Biostatistics, Intellectual Property (IP) and in-licensing, international market expansion, regulatory affairs and compliance.

Responsible for leadership, setup and management of global CLIA- and CAP-accredited clinical/ diagnostic laboratories and the development/validation of AssureRx Health’s innovative personalized genomic tests (GeneSight Psychotropic, GeneSight ADHD and GeneSight Analgesic) for neuropsychiatric disorders. Scaled up operations, redesigned procedures, policies and quality systems and implemented new technical platforms and systems/tools to support increased sample testing volume by >10x.

Responsible for leadership, strategy and implementing scientific and operational infrastructure including informatics, quality and regulatory procedures to advance personalized healthcare (Genomic Medicine) across a network of CHI hospitals. Established a CLIA-certified MDx laboratory and implemented operational (Technical, IT, quality and regulatory) infrastructure to manage clinical study sites and streamline hospital work-flows to procure and annotate high quality biospecimens (Biobanking) with patient medical data. Developed informatics strategies to standardize and integrate patient medical and longitudinal data (EHR) with tissue and genomic data, and create “Patient cohorts” in-silico to support adaptive clinical trials and biomarker discovery and drug development programs.

As a site head, led a CLIA-certified, cGMP/GLP compliant molecular genomics, biobanking and biologics testing facility with responsibilities for day to day technical/scientific operations, Research & Development (R&D), informatics, quality, business operations, customer support, contract administration, and growth and profitability (P&L). Implemented automation and work-flow management systems, and process engineering solutions to support and improve operational efficiencies of a global (US, France, Germany and UK) clinical testing and molecular genomics organization. Led the unit through the sale and aligned with the new corporate strategy; Consolidated regulated facilities and setup a cGMP facility to offer Biologics testing services, which successfully completed >50 audits by pharma/biotech customers, and regulatory inspections by MHRA (UK) ad TGA (Australia).

Formed a global customer service and business operations unit to establish customer support functions and integrate business processes of a highly diverse set of companies that formed a global (US, France, Germany and UK) pharmacogenomics company. Responsible for leadership, business development, Project/Account Management, client relationships, Business Analysis/Reporting, and contract administration. Led an organization wide initiative to implement SOX compliant revenue recognition process that led to the creation of a P&L statement for the newly formed global organization.

Managed an independent business unit (Site head) with P&L responsibilities and led a 41 member unit through different M&A activities, and aligned the division with new corporate strategy. Responsible for developing strategic partnerships and formulating business strategy and implementing marketing strategies for developing new and existing markets for molecular genomics services.

Conducted technical, market, and intellectual property due diligence for a number of opportunities in the biomedical field (both mature and emerging technologies) and provided recommendations on investment decisions. Developed commercial focus, formulated business strategy and co-wrote business and technical plans, which raised funds and launched two Biotech start-ups focussed on developing novel cancer therapeutics. Led efforts to identify contract research organizations for manufacturing cell-based vaccines and conducting clinical trials; evaluated proposals, and developed budget estimates for manufacturing allogeneic B7 vaccine and conducting pivotal phase 2/3 clinical trials. Provided strategic input to streamline operations, seek non-dilutive research funds and develop commercialization strategies for a number of opportunities.

Directed a core Systems Biology group (GEP, Metabolomics and Computational Biology) to elucidate the mode of action (MOA), and a Pathway Engineering group to mass produce biopharmaceutical compounds. Responsibilities include evaluating market potential and competitive landscape of various product concepts, developing commercial and research strategies for both ChemTrait and GreenBiotech projects, and managing IP to develop new technologies for commercial product development.

As a key member of the leadership committee, managed complex situations faced by an entrepreneurial start-up company, and the challenges faced by a growing biotechnology company. Developed infrastructural (research and operational) facilities and revenue recognition models for two high profile projects that lead company’s growth from 25 to 185 employees. Directed a 25-member group including PhD level personnel that developed a high-throughput gene function factory (functional genomics).