Sr. Laboratory Director

Foundation Medicine•Morrisville, NC

3d•Onsite

About The Position

The Senior Laboratory Director (LD) is accountable for the overall operation and administration of a Foundation Medicine clinical laboratory site, including compliance with the applicable regulations, competence of lab personnel performing testing, and accuracy and timeliness of results to deliver excellent patient care and to support business needs. The Senior LD is a strong partner and collaborates with site leadership, particularly Laboratory Operations and Quality Assurance leaders, to ensure the laboratory is compliant with requirements of regulatory agencies, including CAP, CLIA, NYS, and ISO. In addition to overseeing the clinical laboratory, this leadership role serves as a molecular and laboratory medicine subject matter expert to advise decision-makers within Foundation Medicine, including product development teams working with the FDA and external partners in support of the company’s mission to transform cancer care. The Senior LD is responsible for the review and approval of various critical documentation, policies and reports, oversight of clinical testing strategies, assay(s) performance monitoring, and approving validations and verifications of new assays and assay modifications. The Senior LD is supported by Section Directors within Pathology and Diagnostic Medicine. This is a regulated position and additional information may be available from QA on the qualifications for this role pertaining to regulatory guidelines.

Requirements

Doctor of Medicine Degree
8+ 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 or PhD in Genetics or Tumor Genomics or equivalent)
New York State Certificate of Qualification certified (Oncology and Tumor Biomarkers AND Histopathology - General

Nice To Haves

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
Demonstrated Ability to:
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 the Health Insurance Portability and Accountability Act (HIPAA) and importance of patient data privacy
Commitment to Foundation Medicine’s values: Integrity, Courage, Passion

Responsibilities

Site Senior (Medical) Laboratory Director and CLIA license holder accountable for all areas of laboratory clinical operations.
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 and site, Foundation Medicine 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.
Specify in writing the responsibilities and duties of each consultant and each person engaged in the performance of the pre-analytic, analytic and post-analytic phases of testing.
Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
Provide initial and timely periodic 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.
Ensure laboratory staff is appropriately educated, experienced, and/or trained and sufficient to properly supervise, perform and report test results and that documented procedures are followed.
Develop and promote necessary operational performance levels aligned to regulatory requirements and corporate goals and objectives.
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.
Provide strategic direction and planning for the laboratory by monitoring utilization patterns of lab services and advises Leadership and other appropriate staff of developing trends in clinical service needs.
Work with site leadership to establish relationships with key vendors and/or external partners.
Communicate and coordinate with other Foundation Medicine CLIA laboratory directors, as well as Section Directors of Anatomic and Molecular Pathology and the Directors of Diagnostic Medicine Service to ensure consistency in testing across all Foundation Medicine sites.
Provide management and mentorship, including support of annual goal-setting and bi-annual performance reviews, to enable direct reports to meet expectations and to develop additional knowledge and skills to promote career development.
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 Foundation Medicine assays, as applicable.
May participate in research studies leading to abstracts, peer-reviewed publications and presentations at medical/scientific meetings that highlight Foundation Medicine 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.

Benefits

A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for Foundation Medicine's benefits.

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