Job ID: req4138
Employee Type: temporary (less than 20 hrs)
Division: Applied & Development Research Program
Facility: Telework: US
Location: 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.
Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
Program Description
The NCI Division of Cancer Treatment & Diagnosis (DCTD) is conducting three large, national precision oncology clinical trials that are investigating the clinical value of using results from highly specialized clinical research assays of molecular and cellular abnormalities of disease to match patients to personalized treatments targeting those abnormalities. The myeloMATCH trial assigns acute myeloid leukemia (AML) patients to treatments, the comboMATCH trial assigns solid tumor patients, and the immunoMATCH trial assigns melanoma and HNSCC patients. DCTD has tasked the FNLCR to establish and operate a network of skilled and capable internal and subcontractor clinical laboratories to provide these highly specialized research assays – a networked named the MDNet. The myeloMATCH trial seeks to incorporate a new genomic sequencing technology named error-correcting next generation sequencing (EC-NGS) which significantly increases assay sensitivity for detecting gene mutations in AML specimens over existing clinical assays and tests. EC-NSG is anticipated to enable the earliest possible detection of subclinical AML mutations and earliest possible intervention to treat them before they cause clinical relapse. This position seeks to recruit a medical expert who has experience using EC-NSG technology for high sensitivity analysis of leukemia specimens (preferably AML) for mutations and who has expert knowledge of EC-NGS and how to the clinical research laboratories of the MDNet might integrate EC-NGS technology into its analysis of myeloMATCH specimens.
Key Roles/Responsibilities - Provide expert direction, knowledge and opinion about:
- Establishing, validating, and sustaining EC-NSG assays in MDNet laboratories
- Laboratory operation and performance of valid, reliable and sustainable EC-NGS assays in the MDNet
- Integration of EC-NSG based assays into the myeloMATCH trial
- Bioinformatics pipelines that reliably call and report on AML mutations at ultra-high sensitivity
- IDE and other regulatory filings that the FDA may require to utilize EC-NGS in myeloMATCH
Basic Qualifications
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of a PhD or 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
- In addition to the education requirement, a minimum of twelve (12) years of progressively responsible experience
- Board Certification in Internal Medicine and Hematology
- Clinical expertise and practice in AML
- Experience in AML clinical trials
- Laboratory experience establishing one or more valid EC-NSG based assays for leukemia mutations
- Medical laboratory experience directing the analysis of leukemia samples by EC-NGS technology
- Professional knowledge of manufacturing of EC-NGS assay reagents and testing kits
- Professional knowledge of bioinformatics pipelines for analyzing EC-NGS data and reporting on leukemia mutations with ultra-high sensitivity
- Ability to obtain and maintain a security clearance
Preferred Qualifications
Candidates with these desired skills will be given preferential consideration:
- Professional knowledge and understanding of the myeloMATCH trial’s medical and scientific aspects, and the role of laboratory testing in profiling AML mutations and matching those mutations to therapy
- Laboratory experience establishing one or more valid EC-NSG based assays for AML mutations
- Medical laboratory experience directing the analysis of AML samples by EC-NGS technology
- Professional knowledge of manufacturing of EC-NGS assay reagents and testing kits
- Professional knowledge of bioinformatics pipelines for analyzing EC-NGS data and reporting on AML mutations with ultra-high sensitivity
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
32,340.00 - 55,600.00
The posted pay range for this job is a general guideline and not a guarantee of compensation or salary. Additional factors considered in extending an offer include, but are not limited to, responsibilities of the job, education, experience, knowledge, skills, and abilities as well as internal equity, and alignment with market data.
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