Clinical Lab Director

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 as permitted by applicable regulations.

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 required for 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.