Molecular Pathologist ​/ CLIA Director - MoCha

PROGRAM DESCRIPTION

The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research. Our laboratory consists of a dynamic team of over 40 scientific, informatics. and support staff. For 14 years, MoCha has worked closely with the National Cancer Institute’s Division of Cancer Treatment and Diagnosis (DCTD) in support of DCTD-sponsored clinical trials and pre-clinical studies.

We are dedicated to implementing cutting-edge genomic technologies to identify new predictive biomarkers and to make translational discoveries that will improve the lives of patients with cancer.

The successful candidate will serve as CLIA Director of the Molecular Characterization Laboratory’s two CLIA laboratories, directly participating in review of next-generation sequencing (NGS) and other clinical assay results and generation of the final patient reports. This role will provide critical support for NCI-sponsored clinical studies to include clinical trial management, regulation, and protocol development for the large NCI precision oncology initiatives ComboMATCH, iMATCH, and myeloMATCH.

The position will oversee the development and/or validation of new clinical assays and genomic technologies. The successful candidate will be part of the senior leadership team and expected to make substantial contributions to the overall success of the laboratory including presenting findings at scientific conferences and publish in peer-reviewed journals.

Responsibilities:

• Support R&D laboratory projects involving NGS and gene expression profiling from formalin-fixed paraffin-embedded specimens
• Lead assay development and, when needed, analytical validation
• Lead and contribute to research focused on identification and verification of predictive biomarkers
• Represent the CLIA laboratories as part of regulatory meetings
• Support best practices for clinical testing and maintaining CLIA compliance, with support from the Quality Assurance group
• Independently perform pathology review duties
• Support histological verification of clinical specimens and the histopathological analysis of patient-derived xenograft models for DCTD studies
• Present findings at scientific conferences and to NCI leadership; publish in peer-reviewed journals
• Supervise laboratory staff
• Collaborate with NCI colleagues and with thought leaders to support translational studies conducted by NCI’s National Clinical Trials Network
• Mentoring and developing junior scientists and staff in diagnostic assay development and translational research will be a key responsibility of this position
• This position will be full-time onsite and located in Frederick, Maryland

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

• Active, unrestricted medical license in a State, Territory, or Commonwealth of the United States, or in the District of Columbia. Will be required to obtain State of Maryland Medical License once offer is accepted.
  
  Foreign degrees must be evaluated for U.S. equivalency
• Board certification in anatomic and/or clinical pathology
• Board certification in molecular pathology at time offer is accepted
• A minimum of three (3) years of experience directing or supervising high complexity testing in the field of oncology and/or molecular pathology
• In-depth understanding of NGS assay and other common clinical/research platforms including in the areas of quality metrics, germline and/or somatic assay results, and variant interpretation
• Ability to perform genomic analyses using NGS tools such as Integrative Genomics Viewer (IGV)
• Professional mastery of clinical research concepts and expertise in clinical research protocol implementation…