Laboratory Director (ABMG)

The Laboratory Director provides strategic clinical oversight and partnership for Nateras 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.

PRIMARY 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 laboratorys 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.

Team Collaboration & Development

• Leadership & Mentorship: Review and approve assigned work while actively mentoring and developing laboratory personnel to foster professional growth.
• Strategic Planning: Lead succession planning and contingency management initiatives for both the immediate team and the broader business units supported by the laboratory.

Data Privacy & Compliance

• PHI Handling: Regularly handle Protected Health Information (PHI) in both paper and electronic formats, utilizing approved technologies in strict accordance with privacy protocols.
• Mandatory Training: Complete all required HIPAA/PHI privacy, security, and General Policies and Procedures training within the first 30 days of hire.
• Continuous Learning: Maintain up-to-date status on all ongoing Natera training and compliance requirements.

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

KNOWLEDGE, SKILLS, AND ABILITIES

• 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.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Duties typically performed in a 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

PHYSICAL DEMANDS & WORK ENVIRONMENT

Duties are typically performed in a laboratory or office environment, either onsite or remotely. This position requires the ability to review digital or printed pathology materials, use a computer, and communicate effectively with internal stakeholders. Extended periods of screen time may be required. Occasional work outside of standard business hours may be necessary to meet operational needs.

TRAVEL REQUIRED FOR THIS POSITION

No Yes
If yes, anticipated travel: <10%