Head of Pharma Services / CLIA Lab
Genentech, Inc
San Jose
hace 4 días

The Head of Pharma Services for the Roche CLIA Lab in San Jose, California, is responsible for further developing, shaping and driving the strategy for the CLIA lab to deliver on the Pharma Services work for molecular testing to support the Pharma Partnering Business.

This position works closely with senior leadership, San Jose site leadership and the CLIA Laboratory Director. Responsibilities

  • Determine, implement and drive the CLIA strategy for the site
  • Working with other members of Roche senior management to guide and grow clinical laboratory operations
  • Responsible for leading CLIA Operations and all functions as it relates to the Pharma Services activities the lab requires for a successful operation
  • Create and deliver on key CLIA operational and business metrics
  • Support achievement of the Oncology & Genetics Life Cycle Team milestones
  • Oversee implementation of new CLIA assays as endorsed by Oncology & Genetics Life Cycle Team
  • Member of site leadership team Oncology & Genetics Life Cycle Team
  • Ensuring that the clinical laboratory adheres to the quality system approach to testing that provides accurate and reliable patient test results
  • Leading efforts to achieve and maintain appropriate accreditation (e.g., CAP) and licensure (e.g., NYS) for the clinical laboratory for current and future tests.
  • Foster and manage relationship with external partners
  • Ensuring proper training and competency of all clinical laboratory personnel
  • Informing senior management of progress, problems and opportunities
  • Acts as interface between sales, operations and research to drive a successful commercial offering with strong product and market fit
  • Collaborate closely with project team leader(s), Quality and Regulatory
  • Assure compliance with applicable laboratory and healthcare regulations, including assuring that relevant licenses / permit / certifications are obtained / maintained
  • Manages staff; provides staff with coaching, training and opportunities to develop skills, and gives ongoing, constructive and timely feedback on performance and progress toward goals and expectations.
  • Other duties assigned by management Formal Training / Education
  • Bachelor's Degree in a related field required.
  • Ph.D. is preferred.
  • 12+ years of related experience, including 7+ years working in a CLIA laboratory
  • Knowledge of CLIA lab operating model and operations
  • Must have experience working and leading in a CLIA lab as specified in the CLIA regulations ( 493. 1443) and California Business and Professions Code (BPC 1209 (a) to direct a clinical laboratory offering high complexity genetic molecular biology tests Travel Requirements
  • 10% based on business needs
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