ABMGG Boarded Laboratory Director

POSITION SUMMARY

As a 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 and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies.
• Oversee the review and interpretation of genetic variation data: interpret variants detected by multiple technologies (e.g. NGS, microarray, qPCR, etc) in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
• Provide clinical and technical support for genetic counselors and other laboratory personnel.
• Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.             
• Analyze lab data, 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:
  • PT results are returned within established time framesPT reports are reviewed by the appropriate staff
  • 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 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.

May manage a team:

• Review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management.
• Work collaboratively with other departments

QUALIFICATIONS:

• 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. Experience within a high-volume laboratory is preferred.      

• 5 or more years of experience in development and implementation of genetic variant interpretation processes and systems in line with published professional interpretation guidelines. Additional variant interpretation experience and involvement in professional committees and/or organizations is preferred.

• Knowledge of CAP, CLIA, California, and New York state regulations.

• Management experience required.    

• This role works with PHI on a regular basis both in paper and electronic form and has access has access to various technologies to access PHI (paper and electronic) in order to perform the job.

• Employee 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Excellent written and oral communication skills.
• Experience leading and managing teams within a high-complexity laboratory environment that offers screening, constitutional, and somatic clinical testing.
• Strong background in evaluating, interpreting, and reporting of advanced, high complexity molecular technologies used to detect genetic variation including next-generation sequencing and microarrays.
• Understanding of statistical measures utilized in genetic testing and screening.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in BSL-2 lab setting.
• Standing or sitting for long periods of time may be necessary.

• Duties may require working various shifts, weekends, and/or overtime.    

Travel required for this position:

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