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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
The Medical Director is responsible for the development and execution of clinical development strategy. The individual is expected to bring a strong medical and scientific foundation, and will work closely with laboratory developed test (LDT) and in vitro diagnostic (IVD) test development teams to define the most effective approach in LDT, IVD, and 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 and cancer screening.
Medical Director Essential Duties and Responsibilities:
- Be the clinical science lead responsible for successful conception, organization, execution, and 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 and IVD Development Programs in conjunction with the other functional Leads.
- Develop creative but realistic approaches to LDT and IVD development programs and lead clinical efforts to secure regulatory approvals.
- Provide strategic perspective and guidance to research on decisions that may have significant clinical components and implications.
- Collaborate closely with Preclinical, Regulatory, Quality, Clinical Operations, and Bioinformatics to ensure tight strategic integration of product development plans and strategies.
- Participate in major written deliverables (e.g. regulatory submissions, original articles, abstracts, and presentation materials).
MEDICAL DIRECTOR QUALIFICATIONS
- Must possess a strong background in and understanding of molecular oncology and molecular diagnostics.
- Must possess a working knowledge of clinical research with an emphasis on drug development and registration-intent programs.
- Working knowledge of IVD, IDE, QSR, GCP, GCLP, and CLIA regulations strongly desired.
- Experience in oncology diagnostics and/or pharmaceutical industry desired.