Laboratory Director, Genomics (Contract/Part Time)

Stealth Biotech; New York (NY); Hybride; USD 165 000 - 331 000; Temps partiel

Résumé du poste

Stealth Biotech is seeking a board-certified Laboratory Director, Genomics (Contract/Part Time) to serve as the director of record on CLIA certification. The role involves analysis, interpretation, and reporting of genome sequencing results and guiding clinical assay development.

This is a part-time contract with approx. 10 hours/week, primarily remote with periodic on-site presence in the New York City metro.

Qualifications

• PhD or MD required.
• ABMGG board certification required.
• Certificate of Qualification in Genetic Testing or ability to obtain one required.
• Experience with CLIA/CAP permit applications and test submissions required.
• Director of record experience for a CLIA/CAP high-complexity lab required.
• Post-board-certification experience with interpretation of exome/genome data preferred.

Responsabilités

• Serve as Laboratory Director of record.
• Build the quality management system including SOPs, document control, and inspection readiness.
• Annotate and investigate clinical significance of variants.
• Develop and validate new NGS-based tests and translational projects.
• Co-lead integration of genome sequencing into clinical practice.
• Ensure regulatory compliance and personnel qualification.

Formation

PhD or MD in biology, genetics, biochemistry, or a related field

ABMGG Board certified in Clinical Molecular Genetics and Genomics, or Laboratory Genetics and Genomics

Certificate of Qualification in Genetic Testing, or the qualifications to obtain one

Experience with laboratory permit applications and test approval submissions

Experience serving as director of record for a CLIA/CAP high-complexity laboratory

Post-board-certification experience in interpretation and reporting of Exome or Genome Sequencing data and/or large-scale carrier screening

Description du poste

We are an early-stage startup focused on the genomics of complex diseases. We are looking for a board-certified Laboratory Director, Genomics (Contract/Part Time) to serve as director of record on CLIA certification. This is an exciting opportunity to join an early-stage company and guide clinical assay development. The Laboratory Director will be responsible for analysis, interpretation, and reporting of screening results derived from genome sequencing. This individual will contribute significantly to assay development and regulatory compliance.

This is a part-time contract role (approximately 10 hours/week), primarily remote with periodic on-site presence in the New York City metro area.

Job Responsibilities:

• Serve as Laboratory Director of record.
• Build the quality management system, including SOPs, document control, change control for software and models, and inspection readiness.
• Identify, annotate and investigate the clinical significance of variants in molecular assays.
• Work closely with leadership to develop and validate new NGS-based tests and other translational research projects. Assist in creation of an efficient and scalable infrastructure for a high-volume clinical testing laboratory.
• Co-lead efforts to integrate genome sequencing into medical practice.
• Responsible for precision medicine knowledge of variant-disease associations
• Effective communication of results, assay development, and regulatory matters

Position Requirements :

• PhD or MD in biology, genetics, biochemistry, or a related field ( required )
• ABMGG Board certified in Clinical Molecular Genetics and Genomics, or Laboratory Genetics and Genomics ( required )
• Certificate of Qualification in Genetic Testing, or the qualifications to obtain one ( required )
• Experience with laboratory permit applications and test approval submissions ( required )
• Experience serving as director of record for a CLIA/CAP high-complexity laboratory
• At least 4 years of post-board-certification experience in the interpretation and reporting of Exome or Genome Sequencing data and/or large-scale carrier screening is preferred
• Proven track record of hands-on experience in NGS.
• Prior experience establishing initial CLIA and/or other regulatory certification and maintenance
• Experience with bioinformatics pipeline validation under CAP NGS requirements
• Experience bringing assay from development to product (0-to-1) preferred.
• Ensure laboratory personnel meet qualification and licensure requirements
• Excellent verbal and written communication skills