Associate/Assistant Laboratory Director - Organ Health

 

Associate/Assistant Laboratory Director - Organ Health (San Carlos) 

 

POSITION SUMMARY

 

As an Associate Laboratory Director, you have clinical oversight of Natera’s laboratory testing.  You ensure that testing is properly performed, and applicable regulatory standards are met. You are accountable for ensuring that laboratory testing processes consistently provide accurate and reliable patient test results.

PRIMARY RESPONSIBILITIES:

• Review and approve test reports for a variety of clinical molecular/cytogenetic results, including cfDNA testing, and germline testing performed across Natera’s technology platforms.
• Oversee the review and interpretation of genetic testing results and associated variant or analyte data in the context of medical literature, databases and other references, along with relevant patient clinical data.
• Provide technical and clinical support for laboratory staff, genetic counselors, and other clinical personnel.
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.         
• Analyze laboratory and clinical data, and contribute to or write publications for high-quality scientific journals.

May serve as Clinical Consultant. A 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. A Technical Supervisor is responsible for ensuring:

• Appropriate test method selection
• Adequate method validation to determine the accuracy and precision of the test
• Enrollment and active participation of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed in accordance with the CLIA requirements and:

o   PT results are returned within established time frames. PT reports are reviewed by the appropriate staff

o   If applicable, corrective action plans are developed and executed for any unacceptable or unsatisfactory PT results.

• 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 ensure the ongoing competency of all individuals who perform testing;
• Remedial training or continuing education needs are identified, and training is provided; and an approved procedure manual is available to all personnel.

 

QUALIFICATIONS:

• MD, DO and/or PhD in genetics or related field required.
• ABMGG board-certified in Laboratory Genetics and Genomics (LGG) or Clinical Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board required. Board-eligible candidates with strong operational and research experience will also be considered. 
• Current California license as a Clinical Genetic Molecular Biologist required, or applicants must be eligible for the license.
• Current Certificate of Qualification in Genetic Testing from the NYS CLEP required, or applicants must be eligible for the certificate.
• 2 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting, and reporting clinical genetic/genomic data. Experience within a high-volume laboratory is preferred.
• Knowledge of CAP, CLIA, California, and New York state regulations.
• This role works with PHI on a regular basis both in paper and electronic form and has access to various technologies to access PHI (paper and electronic) in order to perform the job.
• Employees must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
• Must maintain a current status on Natera training requirements.
• Employee must pass post-offer criminal background check.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent written and oral communication skills.
• Experience within a high-complexity laboratory environment that offers screening, constitutional, and/or somatic clinical testing. Strong background in evaluating, interpreting, and reporting of advanced, high-complexity molecular technologies used in genetic variation detection and/or cfDNA analysis.
• Understanding of statistical measures utilized in genetic testing and screening.

 

 

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in BSL-2 lab settings.
• Standing or sitting for long periods of time may be necessary.
• Duties may require working various shifts and/or weekends.

Travel required for this position:

No   ☐ or Yes   ☒:  If yes state anticipated percent for travel: up to 10%