Molecular Pathologist - Full Time or Part Time (req2174)

Posted: 10/13/2021
Location: Rockville, MD
Employee Type: exempt part-time
Job ID: req2174

PROGRAM DESCRIPTION

The Leidos Biomedical Research, Inc.'s staff of scientific, technical, and support professionals conduct basic and applied research in cancer and AIDS. It operates and manages the federal government's only vaccine manufacturing facilities (Vaccine Pilot Plant [VPP] and Biopharmaceutical Development Program [BDP]) and runs the high-performance Advanced Biomedical Computing Center. It also operates the Frederick National Laboratory for Cancer Research, a Federally Funded Research and Development Center focused on cancer and AIDS research. The Leidos Biomedical Research Molecular Characterization Laboratory (MoCha) supports projects within the National Cancer Institute (NCI) Division of Cancer Treatment and Diagnosis (DCTD) that require expertise in translational research and clinical trials. The laboratory contains two CLIA accredited clinical laboratories (complex genomics and histology), a research group and a bioinformatic group. MoCha provides clinical genomic assay support and molecular assay expertise for NCI sponsored clinical trials such as NCI-MATCH and Pediatric MATCH. The research group provides WES, RNAseq and digital spatial profiling for NCI's patient derived model repository (PDMR). A major focus of providing robust assay technology requires well defined standard operating procedures of the entire process from sample acquisition through assay reporting. MoCha participates in several public/private consortia focused on best practices and development of appropriate assay controls (e.g. Foundation of the National Institute of Health “Quality Control Material for ctDNA Assays”). Currently, Leidos Biomed is supporting the NCI Cancer Moonshot℠ Biobank program working in close collaboration with NCI's Biorepositories and Biospecimen Research Branch (BBRB). The NCI's Cancer Moonshot℠ program is intended to accelerate cancer research in key strategic areas. The strategic areas were deliberated and identified by experts in the cancer research community convened in 2016 through a “Blue Ribbon Panel” (BRP). The BRP produced a set of recommendations that are now publicly available (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel). The strategic areas addressed in the BRP recommendations have in common two core elements: (1) critical scientific and medical questions, the answers to which could rapidly accelerate progress in cancer research, and (2) the need for nationwide participation by a diverse group of research participants who have agreed to share their biospecimens and/or derived data to contribute to progress in cancer research. The latter element, an engaged and diverse research participant population and their donations of biospecimens and data, will be critical to accelerating research progress and is the subject of the project for which Leidos Biomed is seeking an experienced Molecular Pathologist. The Cancer Moonshot℠ Biobank will provide a networked biospecimen resource that will serve the goal of the Cancer Moonshot℠ to accelerate research progress in cancer. The Cancer Moonshot℠ Biobank study aims to collect up to 2,000 longitudinal high quality specimens from patients with 10 different cancer types, to include tissue resections, core biopsies, fine needle aspirates, bone marrow aspirates, and blood. The biospecimens will be utilized by researchers studying the mechanisms of drug resistance and sensitivity and other important cancer research questions. Agreements with up to 100 different cancer centers will be put in place to enable the engagement and participation of physicians and patients, including minority and underserved as well as adolescent and young adult cancer patients. Tumor molecular characterization tests will be performed as part of the program to help inform patient treatment decisions. Some tissues will be sent for PDMR model development at the Frederick National Laboratory for Cancer Research. A central Biospecimen Core Resource has been engaged for biospecimen processing and storage. A web based portal has been launched providing details of the project, educational information and patient and provider access to clinical reports. Project data will be uploaded to the NCI Clinical Research Data Commons to enable data analysis by the broader research community. The study was initiated over 1 year ago.

KEY ROLES/RESPONSIBILITIES

If an acceptable applicant desires part time employment (20 hours/week), the sole focus of the effort will be in support of the Cancer Moonshot℠ Biobank program. The primary role of the Molecular Pathologist will direct the activities of the Leidos staff, working in close collaboration with NCI staff, in support of the Cancer Moonshot℠ Biobank program. Candidates interested in part-time work to maintain a part-time position at a medical institution may be considered.

  • Address ongoing questions from enrolling sites pertaining to eligibility and specimen characteristics, provide pathology and specimen quality expertise to ensure collection, storage and distribution of fit for purpose biospecimens
  • Provide professional knowledge to guide all aspects of the program including updating the clinical protocol as needed, interacting with site investigators, site and community engagement, develop and provide educational materials, beyond the duties related to clinical pathology of cancer and specimen handling
  • Manage a small group of motivated and knowledgeable individuals focused on project management, information technology, biorepository, and enrolling site interactions
  • Maintain collaborative interactions, and prepare and present updates to all program participants
  • Work closely with the Scientific Program Manager to guide the program, contribute to the development and refinement of protocol approaches, methods, and accrual goals, and review clinical data requirements to ensure clarity
  • Provide consultative services to the principal investigators utilizing the Biobank specimens in support of a wide variety of research activities that include a major focus on functional genomics and disease mechanisms utilizing genetic approaches
  • Contribute to program design discussions, and contribute significantly to the writing of protocol versions and standard operational procedures required for tissue collection, storage, shipment, and pathology review
  • Evaluate and recommend appropriate actions to ensure the program's quality meets required standards set by the MoCha Quality Director
  • Technical expertise expected includes immunohistochemistry, in situ hybridization, mutational analysis, and laser capture microdissection

BASIC QUALIFICATIONS

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

  • Possession of a Doctor of Medicine (MD) degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency
  • If seeking full time employment, will require 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. American Board of Pathology certification in Clinical Pathology and/or Molecular Pathology
  • In addition to education requirements, a minimum of three (3) years experience in molecular pathology-related work
  • Ability to travel when current pandemic environment permits. Travel will include attendance at relevant professional meetings, Moonshot℠ Biobank program meetings and site visits
  • Possess a strong medical background in cancer research and cancer treatments
  • Experience in biobanking processes, including informed consent, laboratory processes for biobanking, use of unique identifiers and specialized containers and preservatives, quality control of biospecimens for advanced molecular analysis, and collection of clinical data for research use
  • Thorough understanding of the current landscape of molecular diagnostic testing for cancer
  • Understanding of laboratory and molecular testing requirements under federal regulatory frameworks (FDA, CLIA)
  • Background working with federally regulated research grants, clinical trials, or pharmaceutical projects
  • Possess a working knowledge of ICH Good Clinical Practices
  • Possess excellent written and verbal communication skills
  • Ability to obtain and maintain a security clearance