Full Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early-stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
To enable Guardant Health to lead the disruption of cancer treatment, the IVD group in Technology Development is seeking a highly motivated Manager to oversee product development, continued product care, and IVDR submission for G360CDx product. In this role the manager will be responsible for leading validation of cutting edge cancer detection diagnostic NGS assays in a regulated environment. The incumbent will work and collaborate cross-functionally with various groups within Guardant for product deliverables. Success in this role requires the ability to think strategically and work within design control and the change control process, while leading verification and validation studies. The ideal candidate will combine leadership capability with strong communication skills and a deep technical understanding of NGS assays to the following tasks:
Provide scientific expertise, and project management skills for IVD verification and validation activities
Ensure product design and development documentation and processes adhere to FDA (510(k) and PMA), IVDR, and other international regulatory agency requirements
Maintain documentation required to meet QSR Design Control, as well as other international standards (e.g., ISO 13485 compliance, GLP/GMP, and IVDR requirements)
Determine strategic approach to experimental design with focus on preventative solutions
Work closely with team leads in program management, assay development, systems engineering, bioinformatics, operations, and software development to develop and validate NGS assays
Collaborating with regulatory and quality partners, to establish and execute plans for assay verification and validation for continued product care
Manage projects and workstreams across the development team, including assessment of workload and resourcing requirements to deliver the teams objectives
Be committed to train, mentor, and develop scientific staff and share best practices across the organization
Support capacity expansion and staffing increase to match company growth
BA/BS with 20+ years of industry experience; MA/MS with 15+ years of industry experience, Ph.D. with 10+ years of post-PhD experience
5 years or more of experience leading small teams; strong leadership capabilities and the ability to lead multiple projects through a complex development program are required
Experience in the development of nucleic acid technologies with a strong preference for experience in sequencing-based genomic assays
Experience working under design control with advanced knowledge of IVD product development and understanding of CLSI, GCP/GCLP, CLIA/CAP guidelines
Experience writing protocols, reports, pre-submissions, 510K/De novo, IDE or PMA submission related documentation for molecular diagnostic applications
Experience with data analysis and interpretation of large data sets, preferably analysis of NGS data using analysis packages such as R, Python, or JMP
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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