Clinical Lab Director

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Clinical Lab Director

Summary

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, including interpretation of genomic findings in myeloid and lymphoid neoplasms, clinical laboratory oversight, and physician consultation. Experience with cytogenetic, molecular, and emerging genome-wide technologies used in the evaluation of leukemia, lymphoma, myelodysplastic syndromes, myeloproliferative neoplasms, and plasma cell disorders is strongly preferred. The laboratory director is responsible for the ongoing performance management and sign out of cytogenetic and molecular testing in accordance with CA State, CLIA and CAP regulations, as well as the implementation and oversight of proficiency testing, quality control and quality improvement programs. Individuals in this position will work closely with senior management to evaluate novel technologies and provide technical expertise on existing platforms.

Primary Duties and Responsibilities

• Oversee, review, and approve proficiency testing and quality reports.
• Responsible for design, review, and approval of validation plans and reports.
• Perform professional interpretation & completion (sign-out) of clinical diagnostic optical genome mapping (OGM) data with use of clinical and phenotypic information for constitutional and oncology applications.
• Provide ongoing updates to clinical tools that allow for improved interpretation and, ultimately, clinical utility including updates to reference files and internal database so clinical cases can be compared to all previously reported results.
• Contribute to scientific and clinical publications, conference presentations, and external educational activities that advance the adoption of genomic testing in hematologic malignancies.
• Provide expert interpretation of structural variants and complex genomic findings in hematologic malignancies, integrating OGM, chromosome analysis, FISH, chromosomal microarray, and NGS findings for collaborative clinical utility evidence and publications.
• Support interactions with regulatory agencies, accrediting organizations, and reimbursement stakeholders, including MolDX, Medicare contractors, commercial payers, and clinical guideline organizations.
• Perform additional related duties as assigned.

Required Skills and Abilities

• 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 (ACMG, CAP, AMP, NCCN, ELN, WHO, and ICC) and molecular cytogenetics nomenclature.
• Understand professional interpretation & completion (sign-out) of structural variants from clinical diagnostic chromosomal microarray (CMA) or other cytogenetic techniques with use of clinical and phenotypic information.
• Understand professional interpretation & completion (sign-out) of clinical diagnostic next-generation sequencing (NGS) assay (gene panel, whole exome, or whole genome) with the use of clinical and phenotypic information.
• Experience with coding and reimbursement (AMA and CMS) including MolDX technical assessment process and understanding of payer requirements for clinical validity and utility.
• Expertise or previous knowledge of OGM is preferred.
• Experience with all CAP/CLIA/CDPH related activities and inspections for leading a clinical laboratory
• Excellent interpersonal and management skills, including proven management, presentation, negotiation and team facilitation.
• Excellent written and oral communication skills with ability to tailor, translate, and communicate complex information in a relevant manner for a broad range of audiences.

Required Qualifications

• Requires an M.D. or Ph.D. or M.D./Ph.D or equivalent in pathology, molecular genetics, or related field.
• Requires 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).
• Requires a Clinical Laboratory Director license appropriate for high-complexity testing, or a California-licensed physician who otherwise qualifies as laboratory director
• Must maintain licensure and continuing education requirements, i.e. attend educational webinars to gain new and additional expertise in areas of interest for the Company. Attend at least one educational conference a year for maintaining CMEs and increase knowledge about advancements in the field of genetics.

Additional Requirements

• Physical Requirements and Work Environment:
• Sit and stand for prolonged periods;
• Repeating motions that may include the hands, wrists and/or fingers;
• Use of hands to finger, handle, or feel, and reach with hands and arms;
• Stand and/or move about the office or in various environments (including tight and confined spaces), or from one worksite to another;
• Specific visual abilities, including close vision and ability to adjust focus, read, review and assess the accuracy and thoroughness of the work assigned;
• Verbal abilities require communicating with others to exchange information;
• Occasionally adjusting or moving objects up to 20 pounds in all directions;
• Work environment involving low/high temperatures; hazardous conditions, low ventilation, noisy environments, small/enclosed spaces.

The above physical requirements and work environment characteristics generally reflect those of this position, but is not an exhaustive list. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Disclaimer

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. This description generally reflects management’s assignment of essential functions but is not intended to be a comprehensive list of the duties and responsibilities of the position, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time. The duties, responsibilities and job description of this role are subject to change at any time without notice.