Summary
Bionano Laboratories, the RUO and CLIA/CAP services business unit of Bionano Genomics, seeks a qualified Clinical Laboratory Director to provide clinical, scientific, regulatory, and operational oversight for high-complexity cytogenetic and molecular testing. This role is responsible for ensuring accurate and timely interpretation, review, and sign-out of clinical diagnostic optical genome mapping and related genomic testing in accordance with applicable California, CLIA, CAP, and company quality requirements. The Clinical Laboratory Director partners with laboratory operations, quality, medical affairs, R&D, and senior leadership to maintain compliant laboratory practices, support assay validation and continuous improvement, and advance the clinical utility of current and emerging genomic technologies.
Primary Duties and Responsibilities
- Provide clinical interpretation, review, and final sign-out of diagnostic optical genome mapping and related genomic testing results for constitutional and oncology applications, incorporating relevant clinical, phenotypic, and laboratory information.
- Oversee report quality, abnormal findings, variants of uncertain significance, clinically significant results, interpretation processes, reference resources, and internal knowledge databases.
- Serve as a laboratory director for assigned CLIA/CAP activities, providing clinical, regulatory, scientific, and operational leadership across pre-analytic, analytic, and post-analytic testing processes.
- Support compliance with CLIA, CAP, California Department of Public Health, HIPAA, and internal quality system requirements, including proficiency testing, quality control, quality assurance, documentation, escalation, and corrective and preventive actions.
- Partner with laboratory operations, quality, technical, clinical, scientific, and research teams on assay validation and verification, test menu updates, workflow improvement, inspection readiness, troubleshooting, evidence generation, publications, and presentations.
- Maintain regular availability for case review, sign-out, escalations, quality meetings, inspection readiness activities, and operational decision-making.
- Provide mentorship, training, competency oversight, and direction to clinical, technical, and quality teams; may supervise personnel or delegated director responsibilities aspermittedby applicable regulations.
- Perform additional related duties as assigned.
Required Skills and Abilities
- Expert knowledge of medical genetics, laboratory genetics and genomics, molecular cytogenetics, structural variant interpretation, ISCN nomenclature, and clinically relevant genotype-phenotype correlation.
- Experience interpreting and signing out results from optical genome mapping, chromosomal microarray, FISH, karyotyping, NGS, or related cytogenetic and molecular platforms; optical genome mapping experience is strongly preferred.
- Working knowledge of ACMG/AMP and related professional guidance for copy number, sequence variant, and structural variant classification, interpretation, and reporting.
- Experience with CAP, CLIA, California Department of Public Health requirements, quality management systems, proficiency testing, assay validation and verification, inspection readiness, and corrective action processes.
- Ability to exercise sound clinical judgment, prioritize work in a regulated clinical environment, and communicate risk, limitations, and interpretation rationale clearly.
- Strong leadership, collaboration, stakeholder management, presentation, and written and verbal communication skills, including the ability to translate complex scientific and clinical information for varied audiences.
- Proficiency with laboratory information systems, clinical reporting tools, reference databases, Microsoft Office applications, and other digital tools used in regulated laboratory operations.
Required Qualifications
- M.D., D.O., Ph.D., M.D./Ph.D., or equivalent doctoral degree in pathology, molecular genetics, laboratory genetics and genomics, medical genetics, or a closely related field.
- Board certification or active board eligibility in Laboratory Genetics and Genomics, Clinical Cytogenetics and Genomics, Clinical Molecular Genetics and Genomics, or another applicable board-recognized specialty; ABMGG certification preferred where applicable.
- Must hold, or be eligible to obtain and maintain, the appropriate California laboratory director license or other applicable California authorization requiredfor the assigned testing scope.
- Must meet applicable CLIA laboratory director qualifications for the complexity and scope of testing performed and maintain required continuing education, licensure, board certification, and professional competency requirements.
- Prior experience directing, supervising, or providing clinical oversight in a high-complexity clinical laboratory is strongly preferred.
- Role may be structured as full-time or part-time depending on business needs, candidate qualifications, availability, and regulatory coverage requirements.
Additional Requirements
Work Location: On-site (Bionano Labs, San Diego)
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 physical requirements and work environment characteristics described above are representative of those typically associated with this position and are not intended to be exhaustive. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.
