Sr. Pathologist and Associate Medical Director

Sr. Pathologist and Associate Medical Director

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) -F1CDx, F1LCDx, and F1Heme- 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 pathologistsupervision 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.

Key responsibilities include providing technical medical oversight for all aspects of molecular genetic pathology testing occurring at each respective site (e.g., CAM or RTP); technical supervision of the Molecular Laboratory staff and testing; ensuring compliance with CAP, CLIA, NYS, ISO15189, and other regulations and standards; review and approval of validation/verification study design and results for molecular testing; providing QC metric interpretation, short variant curation, mathematical copy-number modeling and amplification/deletion calling, and evaluation of DNA- and RNA-based rearrangement calls for individual cases escalated for technical supervisor review as needed; ensuring daily pipeline & curation audits are reviewed by CBO admin staff; direct retrospective result lookback audits as required by NCRs, CAPAs, and for quality improvement; resolve conflicts arising from and/or override curation SOPs when needed to ensure accurate patient care; communicate performance issues with IT systems utilized in post-pipeline analysis (CATi, CRM, HIPR, LIMS, MR2, WLM, etc.) to IT, QA and Laboratory Director; support CBO general supervisors with staff curator education, curation training, and initial and periodic competency assessments; support Laboratory Director in delegation of authority to post-pipeline analysis laboratory staff; develop, document and review KPIs for Ppost-pipeline analysis process as a component of overall lab quality and assay performance monitoring; work with pathologists and other FMI teams to participate in investigation and correction of non-conformances. When appropriate, lead and complete CAPAs; support legal, compliance, regulatory, and QA in appropriate categorization of incidents, documentation of non-conformances (NCRs) involving multiple cases, and investigation of recurrent NCRs and root cause analyses for CAPAs related to post-pipeline analysis; assist Laboratory Director in ensuring quality and patient safety in all aspects of post-pipeline analysis including but not limited to assay analytical validations and design changes, CAP proficiency testing, and the CAP Accreditation Program Molecular Pathology Checklist, etc.

Qualifications include MD with American Board of Pathology certification in Anatomic and/or Clinical Pathology AND Molecular Genetic Pathology; 5-6+ years of diagnostic medicine experience after completion of post-graduate medical training, including subspecialty medical training and diagnostic pathology service. Relevant biomedical or biotechnology research may also be included; documented molecular genetic pathology fellowship training and at least 1 year of experience with high complexity next- generation sequencing testing; New York State Certificate of Qualification eligible or certified in "Oncology-Molecular and cellular tumor markers". Preferred qualifications include subspecialty training and/or expertise in cancer biology, genomics, or clinical trials; strong history of achievement demonstrated by leadership activities, publications, presentations, or other activities; collaboration skills and ability to effectively communicate with internal and external team members; process-oriented, flexible mindset and approach to creative problem solving; demonstrated history of cross-functional leadership and/or participation in cross-functional teams; demonstrated ability to meet deadlines, work well under pressure while maintaining a professional demeanor, self-organize and operate effectively without day-to-day oversight, while staying tightly connected to key leaders and teams across the collaborations; work in a laboratory environment in the presence of chemicals and reagents; understanding of the Health Insurance Portability and Accountability Act (HIPAA) and the importance of patient data privacy; 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 $272,000 - $340,000 per year. The salary range is commensurate with Foundation Medicines 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.

Foundation Medicine