ABMGG Laboratory Director at Natera

Austin, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, GeneticsIndustries

Requirements

MD/DO and/or PhD in genetics or related field
ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology, or equivalent doctoral-level board
Current California laboratory director license
Complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training, and security training within the first 30 days of hire
Maintain current status on Natera training requirements
Pass post-offer criminal background check

Responsibilities

Review, approve, and sign-out reports for clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception, and oncology testing using platforms like SNP array analysis, NGS, and other methodologies
Oversee the review of genetic and CNV variant data; interpret NGS and microarray results using medical literature, online variant databases, other references, and 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 and contribute to or write publications for high-quality scientific journals
If serving as Clinical Consultant: Ensure test reports include pertinent information for test interpretation and availability for consultation concerning test results and their interpretation related to specific patient conditions
If serving as Technical Supervisor: Ensure appropriate test method selection; adequate method verification; enrollment in CMS-approved proficiency testing (PT) program; PT samples tested per CLIA requirements; PT results returned timely; PT reports reviewed; corrective actions for unacceptable PT results; quality assessment and control programs maintained; acceptable analytical performance established and maintained; remedial actions for deviations documented; patient results reported only when system functions properly; personnel trained and competent prior to testing; policies for monitoring personnel competency in all testing phases; remedial training or continuing education provided; approved procedure manual available
Manage a team: Review and approve assigned work; mentor and develop personnel, including succession planning and contingency management
Ensure clinical oversight of laboratory testing, proper performance of testing, and meeting of applicable regulatory standards
Ensure laboratory implements testing while consistently providing accurate and reliable patient test results
Work with PHI in paper and electronic form and access various technologies to access PHI to perform the job

Skills

Key technologies and capabilities for this role

NGSSNP array analysisMicroarrayCNV variant interpretationNIPTCarrier screeningPGD/PGSProducts of conception testingOncology testingCLIA complianceProficiency testingGenetic counseling supportLab data analysis

Questions & Answers

Common questions about this position

What are the main responsibilities of the Laboratory Director role?

The role involves clinical oversight of laboratory testing, reviewing and signing out reports for molecular/cytogenetic and oncologic results, overseeing variant data review, providing support to genetic counselors, setting testing standards, and ensuring regulatory compliance including as Clinical Consultant and Technical Supervisor.

What technical expertise is required for this position?

Expertise in interpreting NGS and microarray results, SNP array analysis, and other methodologies for NIPT, carrier screening, PGD/PGS, products of conception, and oncology testing is required, along with knowledge of medical literature, variant databases, and regulatory standards like CLIA.

Is the salary or compensation mentioned for this Laboratory Director position?

This information is not specified in the job description.

What is the work location or remote policy for this role?

This information is not specified in the job description.

What makes a strong candidate for the ABMGG Laboratory Director role?

A strong candidate will have expertise in clinical molecular diagnostics, experience with NGS, SNP arrays, and cytogenetic testing, the ability to oversee lab operations and ensure CLIA compliance, and skills in variant interpretation and scientific publication.

Natera

Genetic testing and diagnostics solutions provider

About Natera

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Austin, TexasHeadquarters

2004Year Founded

$149.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

Risks

Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.

New Prospera Heart features may face slow adoption by healthcare providers.

Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

Differentiation

Natera's Signatera test offers personalized ctDNA analysis for cancer patients.

Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.

Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

Upsides

Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.

AI integration enhances accuracy and speed of Natera's cfDNA analysis.

Growing personalized medicine trend aligns with Natera's customized genetic tests.

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