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.
TheLaboratory Director is responsible for providing effective clinical leadership for the delivery of laboratory services & products. This position is responsible for clinical oversight of all laboratory operations, including patient care, clinical trial, & clinical research operations, & assuring that such operations are conducted in compliance with the applicable regulations. This position is central to the operation of Guardant's multiple products in multiple different regulatory environments & will become even more so as Guardant moves into further in vitro diagnostic (IVD) development & into cancer screening.
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.
These positions are described jointly as many of these responsibilities overlap & may be filled by a single individual.
Laboratory Director Essential Duties & Responsibilities:
- Delegate the responsibilities of the General Supervisor, Clinical Consultant, Quality Systems Manager & Testing Personnel to employees who are qualified to perform such duties.
- Shall spend a minimum of 16 hours per week onsite, in the laboratory, to direct & supervise the technical performance of the staff & be readily available for personnel or telephone (or electronic) consultation to the laboratory's staff & clients.
- Responsible for designing, validating, & maintaining the technical accuracy & medical reliability of the laboratory test.
- Participation in the quality management system, management of adverse outcomes & non-conformities, participation in the onsite survey, appropriate management of the results of the on-site survey & performance in proficiency testing.
- Provide oversight of all aspects of the laboratory's quality management system to ensure conformance to requirements described in the Quality Management System chapter of the Clinical Laboratory Practice Standards.
- Provide effective & efficient administrative direction of the laboratory, including budget planning & controls in conjunction with the individual(s) responsible for financial management of the laboratory.
- Ensure that qualified personnel are employed; by defining the qualifications & responsibilities of all laboratory technical staff & documenting training and/or competency.
- Provide continuing educational to laboratory technical staff that is relevant to laboratory medicine.
- Ensure that policies & procedures are established for monitoring staff to assess competency, & whenever necessary, provide remedial training or continuing education to improve skills.
- Specify in writing the technical & administrative responsibilities & duties of all laboratory personnel, including assist directors designated in the permit application(s) material submitted to the Clinical Laboratory Evaluation Program. The laboratory director is responsible for competency assessment of direct-report supervisors. Documentation of assessments must be performed annually & whenever new systems are introduced. Remedial steps must be documented when staff do not perform as expected.
- Promote a safe laboratory environment for personnel & the public.
- Ensure that an approved procedure manual is available to all personnel.
- Monitor all work performed in the laboratory to ensure that medically reliable data are generated.
- Assure that laboratory participates in monitoring & evaluating the quality & appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
- Provide advice to referring physicians regarding the significance of laboratory findings & ensure that reports of test results include pertinent information required for specific patient interpretation.
- Ensure that the laboratory is enrolled in the Department's proficiency testing program for the testing performed & that the laboratory adheres to the program's administrative & technical requirements for all tests with no available New York State proficiency test, ensure that the laboratory adopts an alternative method to verify test accuracy & reliability.
- Select all reference laboratories.
- Maintain an effective working relationship with applicable accrediting & regulatory agencies, administrative officials & the medical community.
- Effectively implement a plan of correction to deficiencies identified.
- Ensure that the quality control & quality assessment programs are established & maintained to assure the quality of Clinical Laboratory services provided & to identify failures in quality as they occur.
- Ensure that a General Supervisor provides onsite supervision of high complexity test performance by testing.
- Report all concerns of test quality and/or safety to Supervisor or Safety Officer.
- Review & approve laboratory documentation such as policies & procedures, validation plans & reports, training & competency assessments, & reagent/control/instrument qualifications, quality audits, deviation approval requests, & nonconforming event reports.
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).
LABORATORY DIRECTOR QUALIFICATIONS
- Must be a licensed physician in California (or is eligible for licensure) or have an active California Laboratory Director permit.
- Must possess training and/or experience, obtained within the previous six years, in generally accepted & currently used methods & techniques in one or more categories listed below & must meet one of the following requirements:
- By a physician who is currently certified by the American Board of Pathology in: Clinical Pathology; or Anatomic Pathology; or an area of special competence relevant to the certificate of qualification sought; or be a dentist who is currently certified by the American Board of Oral Pathology; or be a physician or hold an earned doctoral degree from an accredited institution with a relevant chemical, physical or biological science major; and
- Is currently certified by: the American Board of Medical Microbiology; or the American Board of Clinical Chemistry in clinical chemistry; or the American Board of Clinical Chemistry in toxicology chemistry; or the American Board of Forensic Toxicology; or the American Board or Medical Laboratory Immunology; or the American Board of Internal Medicine in hematology; or
- Subsequent to receiving a doctor of medicine, doctor of osteopathy or earned doctoral degree has had, & has documented to the department, four years of training and/or experience in an acceptable laboratory, including two or more years of training and/or experience in methods & techniques currently in use in the certificate category or categories sought & in general laboratory management, or an equivalent combination of training and/or experience as verified by the commissioner.
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 pharmaceutical 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/