Laboratory Director (ABMG)

Natera•San Carlos, CA

7d•$157,600 - $197,000•Hybrid

About The Position

The Laboratory Director provides strategic clinical oversight and partnership for Natera’s Early Cancer Detection program. In this role, you will ensure all laboratory testing is performed to the highest standards, maintaining strict compliance with applicable regulatory frameworks. You will be responsible for overseeing the implementation of new testing methodologies, managing laboratory processes and protocols, and ensuring the consistent delivery of accurate, reliable patient test results.

Requirements

MD/DO and/or PhD in genetics or related field required.
ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required.
Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required.
Current Certificate of Qualification in Genetic Testing from the NYS CLEP required.
5 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.
Knowledge of CAP, CLIA, California, and New York state regulations.
Management experience required.

Nice To Haves

Excellent written and oral communication skills.
Experience leading a laboratory offering prenatal screening and oncology testing and evaluating, interpreting, and reporting out NGS and microarray data.
Familiarity with next-generation sequencing, and/or knowledge of advanced methods of copy number detection.
Strong background in human and medical genetics, and oncology with a familiarity of online human genomics.
Understanding of statistical measures utilized in genetic testing and screening.

Responsibilities

Ensure accurate and timely results for patients.
Oversee and review of genetic data in the context of patient care.
Provide clinical and technical support for testing in the Early Cancer Detection program.
Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.
Ensure compliance with applicable regulatory, quality, and laboratory standards.
Document findings and maintain accurate records consistent with internal policies and procedures.
May service as Clinical Consultant. The clinical Consultant is responsible for ensuring: Test reports include pertinent information for test interpretation, and Availability for consultation concerning test results and the interpretation of those results as they relate to specific patient conditions
May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring: Appropriate test method selection, Adequate method verification to determine the accuracy and precision of the test, Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed, PT samples are tested in accordance with the CLIA requirements, PT results are returned within the time frames established by the PT program, PT reports are reviewed by the appropriate staff, Corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory, Quality assessment and quality control programs are established and maintained, Acceptable analytical test performance is established and maintained for each test system, Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly, Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens, Policies and procedures are established for monitoring personnel competency in all phases (preanalytical, analytical, and postanalytical) of testing to assure the ongoing competency of all individuals who perform testing; Remedial training or continuing education needs are identified, and training provided; and an approved procedure manual is available to all personnel.
Review and approve assigned work while actively mentoring and developing laboratory personnel to foster professional growth.
Lead succession planning and contingency management initiatives for both the immediate team and the broader business units supported by the laboratory.
Regularly handle Protected Health Information (PHI) in both paper and electronic formats, utilizing approved technologies in strict accordance with privacy protocols.
Complete all required HIPAA/PHI privacy, security, and General Policies and Procedures training within the first 30 days of hire.
Maintain up-to-date status on all ongoing Natera training and compliance requirements.