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.
*Eastern time zone preferred*
The Medical Director is responsible for providing effective clinical leadership for the delivery of clinical trials and clinical leadership for the screening program (LUNAR screening products). This position is responsible for clinical oversight of all clinical trial operations, including patient care, and assuring that such operations are conducted in compliance with the applicable regulations. This position is critical to ensuring that clinical leadership plays a role in the development and delivery of blood-based screening programs at Guardant Health.
Medical Director Essential Duties and Responsibilities:
- Responsible for designing protocols, building vendor relationships, and maintaining the clinical program associated with the screening program.
- Participation in the quality assurance, management of adverse outcomes and non-conformities, participation in the onsite/remote monitoring.
- Provide oversight of all aspects of clinical trials, including GCP/GLP.
- Provide effective and efficient administrative direction of the clinical program, including budget planning and controls in conjunction with financial business partners.
- Ensure that qualified personnel are employed; by defining the qualifications and responsibilities of all clinical trial staff and documenting training and/or competency.
- Provide continuing educational to clinical trial staff that is relevant to screening and the current state of the art.
- Ensure that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
- Participate in and provide guidance to specialist services such as medical affairs, data management, statistical analysis and regulatory affairs.
- Promote an audit ready approach to clinical trials.
- Ensure that all clinical trials are suitable for regulatory submission, liase with regulatory agencies as required (remote and in-person as needed)
- Provide advice to referring physicians and patients regarding clinical trial processes
- Maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials and the medical community.
- Review and approve clinical trial documentation such as policies and procedures, validation plans and reports, training and competency assessments, quality audits, deviation approval requests, and nonconforming event reports.
- Opportunities exist to extend into secondary research space including real-world data and analytics.
- MD is required
- Specific clinical experience in preventive care, screening, primary care or oncology will be preferred
- Experience in observational research will be preferred
- At least 3 years experience in a clinical trial environment with demonstrated leadership and participation in cross-functional teams delivering regulatory-grade clinical trials
- Ideally, 1-2 years in an industry role following clinical training
- Strong communication and presentation skills
- Strong leadership skills
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.