Director, Molecular Pathology
Location
Morrisville, NC | United States
Job description
Job Description
About the Job Foundation Medicine performed over 100,000 next-generation sequencing (NGS) tests in 2022 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 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.
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 - 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, ISO15189, 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 actions for molecular testing.
- In conjunction with the CBO team, as applicable:
- Review active and approve revisions to CBO curation SOPs & Work instructions in conjunction with QA, Regulatory, Lab Operations & CLIA Laboratory Director to ensure that they will yield the highest quality of sequencing results.
- Provide 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.
- Ensure 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.
- In conjunction with Director of Anatomic Pathology and the Director, Pathology and Diagnostic Medicine Service, 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.
- Review and approval of updates to laboratory SOPs and other controlled documents, validation/verification qualification results for wet-bench, bioinformatics, and laboratory information system processes, as delegated by the Laboratory Director.
- Provide subject matter expertise and serve as Pathology and Diagnostic Medicine primary point of contact for:
- Issues identified by internal or external parties regarding case curation, both pre- and post-report release.
- Development and approval of educational and/or commercial collateral and communications related to post-sequencing analysis and quality.
- Technology teams on performance and functionality enhancements to and requirements for pre- & post-deployment testing of updates to IT systems utilized in post-pipeline analysis to enable scaling.
- Process excellence and operations initiatives to improve wet-bench and bioinformatics analysis workflow efficiency and maintain quality.
- Development of business continuity and disaster recovery planning for wet-bench and bioinformatics analysis.
- CAP/CLIA, FDA, NYS, ISO 15189, and pharma audits in conjunction with Laboratory Director as director for molecular pathology.
- Tissue and Liquid Portfolio Teams to evaluate impact on molecular testing when considering design changes and/or product improvements.
- Communication to PDM, medical and operations leadership about challenges, concerns, changes, and suggestions from laboratory and CBO staff.
- Provide training and support to relevant staff, as applicable:
- Ensure PDM NGS Result Review and Report approval SOPs and WI are complete and reflect current molecular pathology standards of practice and CAP/AMP guidelines.
- Support training to ensure adherence to SOPs/WI, novel issue identification, and appropriate integration of clinical and genomic information and initial and periodic competency assessments of all pathologists at CAM and RTP who perform NGS Result Review and Report approval.
- Support TOCR and other medical and operations functions to achieve an appropriate level of understanding of post-pipeline sequence analysis.
- Other duties as assigned.
Qualifications Basic Qualifications - MD with American Board of Pathology certification in Anatomic and/or Clinical Pathology AND Molecular Genetic Pathology
- 2+ 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 - 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: innovation, patients, collaboration, and passion
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Essential About Us Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)
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