Full Job 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 is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
This role works out of our Headquarters in Redwood City, CA.
Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as ‘working from home status’, scheduled to return onsite at HQ when it is determined safe to do so.
The Director of Lunar 2 Clinical Operations is responsible for the overall operations of the Clinical Laboratory and the supervision of personnel. This role acts as the liaison between laboratory staff and various departments. As such, the Director of Lunar 2 Clinical Operations must exhibit leadership skills, solid judgment, and the ability to remain professional. Possess effective interpersonal skills and the ability to communicate across all levels of the organization effectively. The ideal candidate must demonstrate the ability to analyze complex issues and make sound decisions promptly. Possess a commitment to helping and motivating employees—the ability to respond to difficult problems quickly in a fair and ethically manor.
The ideal candidate will possess outstanding organizational skills. The ability to respond to change with flexibility and be able to adapt rapidly to evolving circumstances. Will have excellent communication skills, including utilizing various communication channels. Proactively communicate team goals, priorities openly and objectively, as well as corresponding changes, issues, and challenges in the organization.
Oversee the overall operations of the clinical laboratory including but not limited to:
Ensuring test systems are functioning properly
Monitoring patient and quality control testing results
Planning validation and implementation of new test procedures
Supervision of laboratory personnel.
Work with the Clinical Laboratory General Supervisor, Technical Supervisor and the Accessioning Supervisor on the laboratory’s quality control/quality assurance procedures, technical troubleshooting, improvement procedures, reagent manufacturing, and training and education programs
Review and manage stability studies, validation protocols, other process improvements, and new assay projects
Write/review standard operating procedures and technical reports
Responsible for supporting the development, implementation, and continual improvement of the quality management system. Ensuring the integrity of the system is maintained when changes are implemented.
Responsible for establishing and monitoring the appropriateness of the quality policy. Ensuring the quality policy is understood, implemented and maintained at all levels of the organization.
Ensure that the quality objectives are fulfilled.
Responsible for ensuring customer requirements are determined and met.
Responsible for identifying and providing adequate resources/training to ensure effective work performance which includes satisfying requirements for: regulatory, statutory, and customers while supporting and maintaining the effectiveness of the quality system.
Responsible for establishing and monitoring the appropriateness of the quality policy.
Participates in formal reviews of the quality management system in planned Management Review meetings (at a minimum annually), to ensure that the quality management system (QMS) continues to remain suitable and effective.
Perform biennial review of Standard Operating Procedures
Understand Guardant Health’s strategy and pending business opportunities to ensure proper staffing
Budget according to Guardant Health’s strategy
Report all concerns of test quality and/or safety to the Laboratory Director or Safety Officer.
Minimum 10 years of Clinical Laboratory experience OR equivalent experience in a complex, high volume laboratory
Minimum two years of supervisory experience preferred
Laboratory experience within the last year preferred
Experience in molecular biology techniques preferred
Strong working knowledge of local, state, and federal laboratory regulations
Strong communicator with ability to maintain open communication with internal employees, managers, and customers as needed
Able to prioritize and drive to results with a high emphasis on quality
Ability to work as part of a team
Ability to provide direct supervision to testing personnel
Ability to analyze and problem solve complex issues that impact test performance
Strong analysis and problem-solving skills
Strong technical skills and job and industry knowledge
Ability to proactively communicate consistently, clearly, and honestly
Strong automation, computing skills, and project management abilities
Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field.
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.