Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
To enable Guardant Health to lead the disruption of cancer treatment, the Technology Development Team is seeking a highly motivated Manager to oversee late stage Lunar development at Guardant Health. As Manager of Lunar Development, you will lead the group responsible for developing & validating cutting edge early cancer detection diagnostic NGS assays in a regulated environment. The incumbent will work with other teams in technology development as well as collaborate cross-functionally with members of bioinformatics, quality, regulatory affairs, operations, & clinical development. Success in this role requires the ability to think strategically & provide guidance on experimental design, as well as an ability & willingness to engage with the details of experimental execution. The ideal candidate will combine strong leadership capability with strong communication skills, experience working under design control, & a deep technical understanding of NGS assays.
Lead a team of PhD scientists & research associates in work that targets late stage development, verification & validation activities. These activities include:
Working closely with team leads in assay development, engineering, bioinformatics, operations, & software development to develop & validate NGS assays
Working with the Lunar assay validation team, as well as Regulatory & Quality partners, to establish & execute plans for assay verification & validation
Applying knowledge of working under design control to guide the design of verification & validation activities
Supporting capacity expansion & staffing increase to match company growth
Be highly committed to deliver results in a fast-paced & rapidly growing organization
Able to manage multiple projects & work streams across the Lunar development team, including assessment of workload & resourcing requirements to deliver the teams objectives
Be committed to train, mentor, & develop scientific staff
Ensure learnings & best practices are shared across the organization
Experience leading small teams; strong leadership capabilities & the ability to lead multiple projects through a complex development program are required
Experience in development of nucleic acid technologies with a strong preference related to sequencing-based genomic assays
Experience working under design control with advanced knowledge of IVD product development & understanding of GCP/GCLP, CLIA/CAP, ISO13485/15189 guidelines
Experience with data analysis of large data sets, preferably in depth analysis of NGS data using analysis packages such as R, Python, or JMP.
Successful in a fast-paced, multidisciplinary, dynamic, & result-oriented work environment.
Consummate team player: demonstrated ability to contribute in an environment where numerous inputs are required to accomplish complex goals
Curiosity & drive
Sense of humor is a must
Experience writing protocols, reports, pre-submissions, IDE or PMA submission related documentation for molecular diagnostic applications
Experience growing a team to meet company growth objectives preferred.
Handles tight timelines & stress in a constructive manner
High attention to detail, with the ability to create clear & concise technical documentation
Demonstrated ability to organize & communicate complex information in a clear & concise manner to cross-functional audiences.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & will not be discriminated against on the basis of disability.
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