Company Description|Job Description
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 & 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 & 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, & 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 & validate novel technologies for rare variant studies with next-generation sequencing in a regulated environment. At Guardant, we leverage the most advanced technologies & work with leaders in many different fields to create the most impactful & 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, & bioinformatics. Additionally, you will be hands on in the lab designing, implementing, & validating technologies related to liquid biopsy sequencing assays for the early detection, treatment, & monitoring of all cancer types. You will be be authoring & negotiating successful study designs, protocols, & 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 & independently to develop, test & validate technologies for rare variant studies with next-generation sequencing
- Design study protocols, analyze results, & write reports for verification & validation studies pertaining to IVD Submissions & CDx tests with pharma partners
- Actively participate in FDA pre-submissions & discussions
- Lead a small team of scientists & research associates
- Be hands on in the lab to prepare samples for verification & validation studies. Document product development requirements & validation results
- Be highly committed & deliver results in a fast-paced start-up environment
Desired Skills & 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, & 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 & 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, & detailed orientated
- Must be self-driven & strong team player able to work in a fast-paced & high-pressure environment.
All your information will be kept confidential according to EEO guidelines.