Company Description|Job Description
Guardant Healthis 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 Healthhas 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 7,000 oncologists in the care of more than 120,000 patients & is working with more than 50 biopharmaceutical companies.
TheMedical Director is responsible for the development & execution of clinical development strategy. The individual is expected to bring a strong medical & scientific foundation, & will work closely with laboratory developed test (LDT) & in vitro diagnostic (IVD) test development teams to define the most effective approach in LDT, IVD, & companion diagnostic (CDx) clinical studies. This position will coordinate Guardant's efforts to develop new paradigms around the use of liquid biopsy in of clinical practice, including applications in early stage cancer treatment & cancer screening.
Medical Director Essential Duties & Responsibilities:
- Be the clinical science lead responsible for successful conception, organization, execution, & delivery of multiple clinical studies in conjunction with the trial operations team.
- Be a strategic leader providing a strong, clear clinical voice for the LDT & IVD Development Programs in conjunction with the other functional Leads.
- Develop creative but realistic approaches to LDT & IVD development programs & lead clinical efforts to secure regulatory approvals.
- Provide strategic perspective & guidance to research on decisions that may have significant clinical components & implications.
- Collaborate closely with Preclinical, Regulatory, Quality, Clinical Operations, & Bioinformatics to ensure tight strategic integration of product development plans & strategies.
- Participate in major written deliverables (e.g. regulatory submissions, original articles, abstracts, & presentation materials).
MEDICAL DIRECTOR QUALIFICATIONS
- Must possess a strong background in & understanding of molecular oncology & molecular diagnostics.
- Must possess a working knowledge of clinical research with an emphasis on drug development & registration-intent programs.
- Working knowledge of IVD, IDE, QSR, GCP, GCLP, & CLIA regulations strongly desired.
- Experience in oncology diagnostics and/or pharmaceuticl industry desired.
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.
All your information will be kept confidential according to EEO guidelines.
Please visit our career page at:http://www.guardanthealth.com/jobs/