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Molecular Pathologist

Job ID: req1299
Employee Type: exempt full-time
Facility: Frederick: Ft Detrick
Location: PO Box B, Frederick, MD 21702 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public’s interest.  

 Position Overview:

PROGRAM DESCRIPTION         

The Molecular Characterization Laboratory (MoCha) is part of Leidos Biomedical Research’s Clinical Research Directorate (CRD) at the Frederick National Laboratory for Cancer Research (FNLCR). The MoCha Laboratory is responsible for providing high-level research in support of the NCI-Cancer Diagnostics Program (CDP) within the Division of Cancer Treatment and Diagnosis (DCTD). MoCha is charged with the development and application of genomic assays for use in medical research and diagnostics for DCTD-sponsored national extramural clinical trials.

KEY ROLES/RESPONSIBILITIES

  • Support DCTD in their initiative to establish robust and cutting edge molecular assays for genomic and proteomic profiling of patient specimens. This position will serve as a CLIA co-director of the Molecular Characterization Laboratory, directly participating in review of next generation sequencing (NGS) and other types of molecular clinical assay results and in the final approval of patient reports
  • Support R&D laboratory projects involving NGS and gene expression profiling from formalin fixed paraffin embedded specimens
  • Represent the CLIA laboratory as part of regulatory meetings
  • Develop analytical validation plans and guide staff in assay development and analytical validation activities
  • Independently perform clinical duties and function as a collaborator with NCI/NCI cooperative group Principal Investigators
  • Interact with assay development groups and contribute to internal efforts to keep technologies current and effective
  • Provide medical oversight of clinical evaluations necessary to conduct clinical laboratory studies in support of DCTD/Cancer Therapy Evaluation Program (CTEP) sponsored trials
  • Support the histological verification of clinical specimens and the histopathological analysis of patient-derived xenograft models for DTCD studies
  • Author documents, review research and clinical protocols, and contribute to the development and refinement of protocol approaches and methods 
  • This position will be located in Frederick, Maryland

BASIC QUALIFICATIONS

This is a dual level requisition. It may be filled at either a Physician II or Physician III level. 

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

Basic Qualifications for a Physician II:

  • Training/experience in the field of oncology and/or molecular pathology
  • Current professional license in Medicine 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. Completion of medical residency and/or fellowship in applicable specialty area as designated by the Program requirements. Board certified in applicable specialty area or equivalent clinical experience
  • A minimum of one (1) year of relevant experience

Basic Qualifications for a Physician III:

  • Training/experience in the field of oncology and/or molecular pathology
  • Current professional license in Medicine 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. Completion of medical residency and/or fellowship in applicable specialty area as designated by the Program requirements. Board certified in applicable specialty area or equivalent clinical experience
  • A minimum of three (3) years of relevant experience

Both the Physician II and Physician III require:

  • Training/experience in the field of oncology and/or molecular pathology
  • In-depth understanding of NGS assay platforms, including: experience with quality metrics data, review of germline and/or somatic assay results for validity, interpretation of variants in the context of the medical literature (experience with oncology and germline diagnostics including hereditary cancer syndromes desired)
  • Ability to perform genomic analyses using NGS tools such as Integrative Genomics Viewer (IGV)
  • Correspondence with medical geneticists and oncologists in the interpretation of NGS results 
  • Professional mastery of clinical research concepts and expertise in clinical research protocol implementation and management
  • Ability to successfully perform in a highly matrix collaborative team
  • Proven track record of relevant publications
  • Background with federally-regulated research grants, clinical trials and/or pharmaceutical studies
  • Working knowledge of Good Laboratory Practices (GLP) and CMS CLIA regulations (or equivalent regulatory programs, e.g. CAP)
  • Strong writing skills and ability to author documents including manuscripts for publications, SOPs, clinical protocols etc.
  • This position is subject to obtaining a Public Trust Clearance.

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Direct management experience, regulatory knowledge pertinent to CLIA or FDA guidelines for clinical assays
  • Familiarity with patient derived xenograft and pre-clinical drug studies
  • Experience with relevant molecular (e.g. RT-PCR) and protein-based clinical assays (e.g. IHC, IFA, etc) is highly preferred

EXPECTED COMPETENCIES

  • In‐depth understanding in molecular biology techniques, oncology and clinical research
  • Excellent communication skills (written and oral)
  • Ability to work effectively in a team‐oriented environment

JOB HAZARDS

  • This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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