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.
This role will represent technology development in the context of regulatory submissions in Japan and Asia. The individual will provide technical guidance for activities related to submission in Japan based on a deep understanding of the G360 CDx test, underlying technology, and the V&V package developed in the context of US FDA submissions and other validation activities. This role will have access to local R&D project teams and will ensure the timely preparation of organized and scientifically valid regulatory documentation for Guardant Health submissions and responses to PMDA during review. The liaison will also provide technical and regulatory guidance for analytical, and clinical study designs based on available data in the U.S. and Japan; support protocol development and all PMDA/MHLW pre-market and post-market submissions.
The incumbent will be expected to understand broad landscape of companion diagnostic regulations, represent technical team in communication with agencies in Japan / AMEA, align efforts with partners and stakeholders, and optimize timelines while mitigating risk.
Essential Duties and Responsibilities:
- Provide strategic input and technical guidance on data in support of regulatory requirements to the Japanese Regulatory Affairs team members based on knowledge and understanding from Guardant Health Inc. (GHI).
- Liaise with RWC technical and regulatory teams to support questions & clarifications from PMDA.
- Review and understand technical content of US FDA submission across the technology stack, including assay validation and bioinformatics approaches and software.
- Coordinate responses to PMDA submission across all technical streams for the Japan Medical Device Software submission and develop follow-up program to address regulatory audit findings.
- Coordinate and support CDx activities & milestones for GH AMEA.
- Anticipate regulatory obstacles and emerging issues throughout the medical device product development lifecycle and develop solutions with other members of technical and regulatory teams.
- Guide and oversee preparation of documentation for PMDA submissions for approvals in coordination with RWC and JP regulatory teams and device licenses.
- Advanced degree (e.g. M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Chemical or Engineering field
- Minimum of 10 years of medical device / pharmaceutical / biologics development experience, including leadership and/or senior consulting experience
- Familiarity with local and preferably global medical device regulations and standards for IVD (In vitro diagnostic) products
- Experience in 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 with data analysis of large data sets, preferably analysis of NGS data using analysis packages such as R, Python, or JMP
- Writing skills to prepare documents including but not limited to strategy documents and submissions to regulatory agencies
- Limited proficiency or more in Japanese language preferred
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.
All your information will be kept confidential according to EEO guidelines.
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.