Associate Laboratory Director

Associate Laboratory Director

The Associate Laboratory Director supports the operation and administration of an FMI clinical laboratory site under the direction of the Laboratory Director/CLIA license holder. This role contributes to ensuring compliance with applicable regulatory requirements, the competence of laboratory personnel performing testing, and the accuracy and timeliness of laboratory results to support excellent patient care and business needs.

The Associate Laboratory Director partners closely with site leadershipparticularly Laboratory Operations and Quality Assuranceto help maintain compliance with regulatory and accreditation requirements, including CAP, CLIA, NYS, and ISO. Working in collaboration with the Laboratory Director, this role assists in regulatory readiness, inspections, corrective actions, and ongoing quality improvement activities.

In addition to supporting clinical laboratory oversight, the Associate Laboratory Director serves as a molecular and laboratory medicine subject matter expert, providing scientific and clinical input to internal stakeholders, including product development teams and external partners, in support of regulatory submissions and the company's mission to transform cancer care.

The Associate Laboratory Director participates in the review of laboratory documentation, policies, procedures, and reports; contributes to oversight of clinical testing strategies and assay performance monitoring; and supports the validation and verification of new assays and assay modifications. This role works collaboratively with Section Directors within Pathology and Diagnostic Medicine to ensure high-quality, compliant, and scalable laboratory operations.

This is a regulated position, and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Key Responsibilities

• Supports the operation and administration of an FMI clinical laboratory site under the direction and delegation of the Laboratory Director/CLIA license holder.
• In partnership with Lab Operations Site Head, Director of Quality Assurance Lab Operations, QA LabOPs Licensure & Accreditation team, and Lab Directors (LDs) and Operations Leadership at other sites, ensure laboratory compliance with all international, US federal and US state laws and regulations that govern the laboratory's operations (CLIA, NYS, and other state laboratory standards). This includes providing supervision of all testing personnel and reporting of test results and adherence to FDA requirements where applicable.
• Ensure compliance with clinical laboratory accreditation agency (CAP and ISO 15189) requirements and terms of accreditation, including participation in required inspections, audits and self-inspections.
• Communicate with laboratory regulatory and accrediting bodies as necessary and comply with regulatory and accrediting body requests for information in the event of an investigation.
• Ensure that the laboratory is appropriately staffed and resourced, in collaboration with Lab Operations Site Head and other functional leaders. Partner with operational and functional leaders to monitor and sustain resource levels necessary to sustain quality and safe laboratory operations.
• Ensure testing systems in the laboratory provide quality services in all aspects of test performance including how the results are reported out.
• In collaboration with Quality teams, site, and LDs ensure the implementation of an effective Quality Management System, as well as ongoing monitoring and improvement of the system.
• Support assay validation/verification and optimization, as well as ongoing proficiency testing, alternative assessment and quality control procedures.
• Ensure that the laboratory participates in and compliantly completes all steps in an HHS approved proficiency testing program, as applicable.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified and that patient test results are reported only when the system is functioning properly.
• Provide initial and timely review and approval of all required laboratory documents, including test validations, standard operating procedures, non-conformances, planned deviations, installation/operational qualifications, and other technical documentation.
• Provide clinical expertise for corporate initiatives to modify existing tests, expand new testing capabilities. This includes involvement in the selection and monitoring of laboratory equipment, supplies and services, as well as the selection and monitoring of laboratory suppliers and referral laboratories.
• Communicate and coordinate with FMI CLIA laboratory directors, as well as Section Directors within Pathology to ensure consistency in testing across all FMI sites.
• As a member of the pathology and diagnostic medicine leadership team, contribute to functional goal setting, strategy development and tactical planning to achieve desired business outcomes and meet medical team and corporate objectives. Coordinate collection and monitoring of Key Performance Indicators (KPIs) and develop team resourcing plan aligned with operational demands and business needs.
• Contribute clinical and subspecialty subject matter expertise to cross-functional initiatives to enhance patient-centric innovation, improve clinical and biopharma customer experience and optimize business performance. Represent lab and quality needs within cross-functional projects.
• Participate in providing diagnostic medicine services, including consulting on clinical questions for FMI assays, as applicable.
• May participate in research studies leading to abstracts, peer-reviewed publications and presentations at medical/scientific meetings that highlight FMI as a world leader in regulatory, scientific and clinical innovation.
• Attend and participate in key meetings and committees.
• Maintain an on-site presence at least 50% of the time.
• Other duties and responsibilities applicable to pathology and diagnostic medicine, as assigned.

Qualifications

Basic Qualifications

• Doctor of Medicine Degree
• 5-6+ years of working experience after completion of clinical training, in the areas of diagnostic pathology, molecular pathology, laboratory medicine, biomedical research, or biotechnology
• Active, Unrestricted Medical Licensure in the state of lab location
• American Board of Pathology Anatomic Pathology board certified
• Molecular Pathology/Genomics certification (Molecular Pathology Fellowship and board certification)
• New York State Certificate of Qualification certified (Oncology and Tumor Biomarkers AND Histopathology General

Preferred Qualifications

• 12+ years of working experience after completion of clinical training, in the areas of diagnostic pathology, molecular pathology, or laboratory medicine in a CLIA-certified clinical laboratory
• Prior experience as a CLIA Lab Director of record or laboratory Section Director
• Experience with designing validation and verification strategies and interpreting study results for execution under CAP/CLIA/FDA regulations
• Prior experience in a role providing laboratory oversight, including interactions with lab certifying agencies and positive management/communications skills with lab employees
• Ability to demonstrate practical applications and flexibility in adapting programs and services to meet specific requirements
• Consistently meet deadlines and respond to inquiries, emails, and team needs in a timely manner
• Work well under pressure and make decisions while maintaining a professional, collaborative and team-oriented environment
• Work in a laboratory environment in the presence of chemicals and reagents
• Strong history of achievement demonstrated by leadership activities, publications, presentations and/or other activities
• Process-oriented, flexible mindset and approach to creative problem solving
• Excellent and demonstrated leadership skills, particularly cross-functional leadership and/or leadership of cross-functional teams
• Effective and analytical decision making, keeping the patient at the center of everything we do
• Collaboration skills and the ability to effectively communicate (written and oral) with internal and external team members on project activities
• Understanding of HIPAA and importance of patient safety and data privacy regulations and guidelines
• Commitment to reflect FMI's values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $217,000 $239,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.