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Clinical Diagnostics Lead, CDx

Company: Guardant Health
Location: Redwood City
Posted on: May 3, 2021

Job Description:

Company 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.

Job Description

TheClinical Diagnostics Lead, CDx will be solely responsible for leading the clinical and technical aspects of companion diagnostic (CDx) development at Guardant Health. The individual will partner closely with a CDx program lead to generate optimal development project plans and program strategy and ensure on-time and on-spec execution of the same. Together with the CDx program lead, this position will oversee and ensure execution by affiliated teams in clinical operations, regulatory, quality, software, business development, and commercialization. This position will also be expected to act as an individual contributor as needed, including as the primary clinical science contributor.

This individual will also have the opportunity to partner with other teams within Guardant and externally to develop new applications of liquid biopsy in clinical practice, including applications in early stage cancer treatment and cancer screening.

The candidate is expected to have a strong clinical and scientific foundation and to have working knowledge of in vitro diagnostic (IVD), medical device, and/or oncology drug development, including United States (US) regulatory submission pathways. Knowledge of ex-US regulatory pathways and experience in oncology diagnostic development is a strong advantage. The candidate is also expected to have excellent oral and written communication and organizational skills and a demonstrated ability to coordinate and deliver complex projects on timeline both as a team leader and as a clinical science individual contributor.

Clinical Diagnostics Lead Essential Duties and Responsibilities
Develop creative but realistic approaches to CDx development and lead clinical and technical efforts to secure regulatory approvals and maximize their impact. Deliver exceptional-quality written deliverables (e.g. regulatory submissions, original articles, abstracts, and external partner presentations) as an individual contributor and ensure the same from the clinical and technical teams. Be the clinical science lead and individual contributor responsible for successful conception, organization, execution, and on-time delivery of multiple clinical studies supporting IVD/CDx development in collaboration with other development team functions. Be the technical science lead responsible for conceiving optimal analytical validation and software development strategies and oversee those teams execution to ensure on-time and on-spec delivery. Coordinate with regulatory experts to ensure robust viability of all development plans. Be a strategic leader providing a strong, clear clinical voice for the IVD/CDx development program in conjunction with the other functional leads both within Guardant as well as with our external biopharmaceutical and academic collaborators.
Professional degree (e.g. MD, PhD, DPharm) with training applicable to the position. Must possess exceptional organizational skills and a demonstrated ability to coordinate and deliver complex projects on timeline. Must possess strong communication skills and a demonstrated ability to produce high-quality, regulatory-grade written deliverables as an individual contributor and ensure the same from teams that they oversee. Must possess a strong grounding in the fundamentals of and effective working knowledge of clinical development with an emphasis on IVD, medical device, and/or oncology drug development and registration-intent programs. Must possess a strong grounding in the fundamentals of and effective working knowledge of IVD, IDE, QSR, and GCP regulations and US regulatory pathways; familiarity with GCLP regulations desired. Must possess a strong grounding in the fundamentals of and effective familiarity with molecular oncology and molecular diagnostics. Experience in oncology diagnostics and/or biopharmaceutical industry desired.
Additional Information

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 .

Keywords: Guardant Health, Redwood City , Clinical Diagnostics Lead, CDx, Other , Redwood City, California

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