ABOUT OUR COMPANY
We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.
To enable Guardant Health to lead the disruption of cancer treatments through non-invasive cancer screening, the Technology Development Team is seeking a highly motivated Development Staff Scientist/Sr Staff Scientis to help develop and validate novel technologies for rare variant studies with next-generation sequencing in a regulated environment. At Guardant, we leverage the most advanced technologies and work with leaders in many different fields to create the most impactful and meaningful technologies for cancer management.
As a Staff Scientist/Sr Staff Scientist in the IVD Technology Development Team, you will work as a technical lead in cross-functional teams including regulatory, process engineering, clinical operations, research operations, and bioinformatics. Additionally, you will be hands on in the lab designing, implementing, and validating technologies related to liquid biopsy sequencing assays for the early detection, treatment, and monitoring of all cancer types. You will be be authoring and negotiating successful study designs, protocols, and reports for NGS technologies, guiding junior team members in delivering successful validation.
Technical lead for V&V studies on IVD development projects using Next Generation Sequencing technology
Be able to work in a cross-functional team environment and independently to develop, test and validate technologies for rare variant studies with next-generation sequencing
Design study protocols, analyze results, and write reports for verification and validation studies pertaining to IVD Submissions and CDx tests with pharma partners
Actively participate in FDA pre-submissions and discussions
Lead a small team of scientists and research associates
Be hands on in the lab to prepare samples for verification and validation studies
Document product development requirements and validation results
Be highly committed and deliver results in a fast-paced start-up environment
Desired Skills and Experience:
Ph.D. with 10+ years or M.S. with 13+ years of experience in genomics or molecular biology developing genomic assays
Must have experience working in a regulated environment, including developing IVD assays. PMA submission experience, and additionally working with CDx assay development preferred.
Must have experience in development or validation of nucleic acid technologies with a strong preference related to NGS based genomic assays.
Strong documentation skills, especially writing study protocols and reports for FDA submissions.
Experience with DOE, statistical analysis, and/or bioinformatics analysis of NGS data is a plus
Experience managing direct and/or indirect reports, as well as working in cross-functional teams as a technical lead
Excellent interdisciplinary communication skills required
Good organization skills, and detailed orientated
Must be self-driven and strong team player able to work in a fast-paced and high-pressure environment.
All your information will be kept confidential according to EEO guidelines.