Clinical Lab Director

Bionano • San Diego, CA

13d • Onsite

About The Position

Bionano Laboratories, the RUO and CLIA/CAP services business unit of Bionano Genomics, seeks a board-certified pathologist and/or laboratory geneticist with significant experience in hematologic malignancies. The role involves interpreting genomic findings in myeloid and lymphoid neoplasms, clinical laboratory oversight, and physician consultation. Experience with cytogenetic, molecular, and emerging genome-wide technologies used to evaluate leukemia, lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, and plasma cell disorders is strongly preferred.

The Clinical Lab Director manages ongoing performance and sign-out of cytogenetic and molecular testing in accordance with California state, CLIA, and CAP regulations, and oversees proficiency testing, quality control, and quality improvement programs. The director works closely with senior management to evaluate novel technologies and provide technical expertise on existing platforms. The position is on-site at Bionano Laboratories in San Diego.

Requirements

• M.D., Ph.D., M.D./Ph.D., or equivalent in pathology, molecular genetics, or a related field.
• Board certification or eligibility for board certification in Laboratory Genetics and Genomics (LGG), or Clinical Cytogenetics and Genomics, by the American Board of Medical Genetics (ABMGG).
• A Clinical Laboratory Director license appropriate for high-complexity testing, or a California-licensed physician who otherwise qualifies as a laboratory director.
• Deep and broad knowledge of medical genetics and expertise in the genetics and genomics of hematologic malignancies, including AML, MDS, ALL, CLL, MPN, CMML, plasma cell neoplasms, and lymphoma.
• Thorough knowledge of medical guidelines, including ACMG, CAP, AMP, NCCN, ELN, WHO, and ICC, and of molecular cytogenetics nomenclature.
• Knowledge of professional interpretation and sign-out of structural variants from clinical diagnostic chromosomal microarray (CMA) or other cytogenetic techniques, using clinical and phenotypic information.
• Knowledge of professional interpretation and sign-out of clinical diagnostic NGS assays, including gene panels, whole exome, or whole genome, using clinical and phenotypic information.
• Experience with coding and reimbursement (AMA and CMS), including the MolDX technical assessment process and payer requirements for clinical validity and utility.
• Experience with CAP/CLIA/CDPH activities and inspections for leading a clinical laboratory.
• Excellent interpersonal and management skills, including management, presentation, negotiation, and team facilitation.
• Excellent written and oral communication skills, with the ability to tailor and communicate complex information to a broad range of audiences.
• Maintain professional licensure and continuing education requirements.

Nice To Haves

• Experience with cytogenetic, molecular, and emerging genome-wide technologies used to evaluate hematologic malignancies.
• Expertise or previous knowledge of optical genome mapping (OGM).

Responsibilities

• Oversee, review, and approve proficiency testing and quality reports.
• Design, review, and approve validation plans and reports.
• Interpret and sign out clinical diagnostic optical genome mapping (OGM) data, using clinical and phenotypic information for constitutional and oncology applications.
• Update clinical tools, reference files, and internal databases to improve interpretation and enable comparison of cases with previously reported results.
• Contribute to scientific and clinical publications, conference presentations, and external educational activities supporting adoption of genomic testing in hematologic malignancies.
• Interpret structural variants and complex genomic findings in hematologic malignancies, integrating OGM, chromosome analysis, FISH, chromosomal microarray, and NGS findings to support clinical utility evidence and publications.
• Support interactions with regulatory agencies, accrediting organizations, reimbursement stakeholders, MolDX, Medicare contractors, commercial payers, and clinical guideline organizations.
• Perform additional related duties as assigned.
• Maintain licensure and continuing education requirements, including attending educational webinars and at least one educational conference annually.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree