Sr. Pathologist and Associate Medical Director

About the Job:

Foundation Medicine performs over 100,000 next-generation sequencing (NGS) tests annually with volumes expected to increase as more physicians order comprehensive genomic profiling (CGP)
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Heme- testing for their patients. The scale and complexity of this volume of testing and the evolving testing menu requires involvement of Pathology and Diagnostic Medicine in all steps of the process. In particular, it is critical that a board-certified molecular genetic pathologist with training and experience in next-generation sequencing is available during wet lab sequencing, post-pipeline sequence data curation, and variant classification and interpretation to ensure that the results accurately reflect the biology of the patient’s sample and follow CAP/CLIA/NYS/FDA guidelines for the performance of each assay.

The role of Director, Molecular Pathology centralizes these responsibilities to one pathologist–supervision of molecular technologists (CAM and RTP); review of wet lab sequencing metrics and troubleshooting (CAM and RTP); supervision of bioinformatics case curation by computational biology operations (CBO) (CAM); ongoing reevaluation and updating of curation SOPs (CAM); ensuring adequate post-pipeline analysis training for members of CBO, TOCR, the MSL team, and pathology (CAM);

collaboration with other FMI stakeholders (CAM and RTP); and final release of CGP results to patients and their physicians (CAM and RTP). This supervision will allow FMI to identify problems as they arise and work toward implementing permanent solutions. The Director, Molecular Pathology is a results-oriented medical operations leader, reporting to the Senior Laboratory Director at the local site (CAM or RTP).

In addition, this pathologist will also continue to participate in the Diagnostic Medicine service.

• Provide technical medical oversight for all aspects of molecular genetic pathology testing occurring at each respective site (e.g., CAM or RTP); note that some elements of testing (e.g., CBO curation in CAM) are presently only carried out at one site.
  • In conjunction with the General Supervisors of the Molecular Lab Operations team, provide technical supervision of the Molecular Laboratory staff and testing:
    • Review active and approve revisions to Molecular Lab SOPs & Work instructions in conjunction with QA, Regulatory, Lab Operations, and CLIA Laboratory Director to ensure high quality sequencing results.
    • In conjunction with Assay Excellence, review sequencing metrics for controls and patient samples and support/lead investigations as required by NCRs, CAPAs, and for quality improvement. This may also include support of quality projects with other teams.
    • Ensure resolution of technical problems and that corrective actions are taken.
    • Partner with stakeholders across FMI laboratories to ensure regulatory compliance and quality of operational services within and across sites.
    • Ensure competency of testing personnel.
    • Available to the laboratory and other stakeholders for clinical patient care and technical consultation.
    • In conjunction with the Director of Diagnostic Medicine, review pathologist training and competency, as well as optimization of clinical services for Report Approval and On-call services.
    • In parallel with the DM Service Director, serve as point of contact for patient testing-related questions from on-call pathologists and other teams.
  • In conjunction with Laboratory Director, Quality Assurance, and Regulatory Affairs:
    • Ensure compliance with CAP, CLIA, NYS, ISO
      15189, and other regulations and standards.
    • Review and approve validation/verification study design and results for molecular testing, with oversight of updates to wet-bench and bioinformatics processes and appropriate re-validation/verification.
    • Ensure participation in proficiency testing and/or alternative assessment, with review and approval of testing results.
    • Establishment of a quality control program to monitor ongoing test performance.
    • Review analytical and clinical performance characteristics of each test and ensure maintenance of quality.
    • Review and approve QC data, control procedures, and corrective…