Associate Laboratory Director
Foundation Medicine
August 29, 2026
Full-time
On-site
Boston, MA
Operations
Role: Support and oversee operations of FMI's clinical laboratory as Associate Laboratory Director, ensuring regulatory compliance, quality, and scientific integrity in molecular and diagnostic pathology. Responsibilities: collaborate with site leadership to maintain CLIA, CAP, ISO, NYS standards; supervise testing personnel; review technical documentation; support assay validation, verification, and performance monitoring; lead quality improvement initiatives; contribute scientific expertise to product development, regulatory submissions, and clinical projects; participate in cross-functional strategy and research activities; ensure regulatory readiness and inspection preparedness; maintain on-site presence at least 50%. Qualifications: MD with active unrestricted license, Board-certified in anatomic pathology, molecular pathology/genomics certification, 5-6+ years post-training experience in diagnostic pathology, molecular pathology, or laboratory medicine, including experience in CLIA-certified labs; NY State QC certification required. Preferred: 12+ years of relevant experience, prior lab director experience, expertise in validation strategies, regulatory interactions, strong leadership, communication, and collaboration skills. High-Value: molecular diagnostics, oncology/tumor biomarkers, CLIA/CAP/ISO compliance, regulatory oversight, research publications. Location: On-site in Boston, MA, with at least 50% presence required.