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, clinical laboratory oversight, and physician consultation. The role oversees the ongoing performance and sign-out of cytogenetic and molecular testing in accordance with California state, CLIA, and CAP regulations, and implements and oversees proficiency testing, quality control, and quality improvement programs. The Clinical Lab Director works closely with senior management to evaluate novel technologies and provide technical expertise on existing platforms. The position includes professional interpretation and sign-out of clinical diagnostic optical genome mapping (OGM) data, using clinical and phenotypic information for constitutional and oncology applications. The director also supports interpretation of complex genomic findings by integrating OGM, chromosome analysis, FISH, chromosomal microarray, and NGS findings. The role contributes to clinical tools, reference files, internal databases, scientific publications, conference presentations, and educational activities, and supports interactions with regulatory, accreditation, reimbursement, and clinical guideline organizations. This is an on-site position at Bionano Laboratories in San Diego. The position requires an M.D., Ph.D., M.D./Ph.D., or equivalent in pathology, molecular genetics, or a related field; relevant board certification or eligibility; and a California clinical laboratory or medical license. The director must maintain licensure and continuing education requirements, including attending at least one educational conference each year.

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).
California Clinical Laboratory Director (CLD) license, Clinical Laboratory Scientist (CLS) license, or a license to practice medicine in California.
Demonstrated 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 molecular cytogenetics nomenclature.
Ability to interpret and sign out structural variants from clinical diagnostic chromosomal microarray or other cytogenetic techniques using clinical and phenotypic information.
Ability to interpret and sign out clinical diagnostic NGS assays, including gene panels, whole exome, or whole genome, using clinical and phenotypic information.
Experience with coding and reimbursement, including AMA and CMS, the MolDX technical assessment process, and payer requirements for clinical validity and utility.
Experience with CAP, CLIA, and 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, including the ability to communicate complex information appropriately to broad audiences.
Maintain licensure and continuing education requirements, including educational webinars and at least one educational conference per year.

Nice To Haves

Experience with cytogenetic, molecular, and emerging genome-wide technologies used to evaluate leukemia, lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, and plasma cell disorders.
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.
Perform professional interpretation and sign-out of clinical diagnostic OGM data using clinical and phenotypic information for constitutional and oncology applications.
Provide ongoing updates to clinical tools, reference files, and internal databases to improve interpretation and clinical utility and enable comparison with previously reported results.
Contribute to scientific and clinical publications, conference presentations, and external educational activities that advance 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 collaborative clinical utility evidence and publications.
Support interactions with regulatory agencies, accrediting organizations, reimbursement stakeholders, clinical guideline organizations, MolDX, Medicare contractors, and commercial payers.
Work with senior management to evaluate novel technologies and provide technical expertise on existing platforms.
Maintain required licensure and continuing education, including attending at least one educational conference annually.
Perform additional related duties as assigned.