Research Associate II - Clinical PD Biomarkers Program

Job

Employee Type: exempt full-time

Division:
Applied & Development Research Program

Facility:
Frederick:
Ft Detrick

Location:

PO Box B, Frederick, MD 21702 USA

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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

The Frederick National Laboratory for Cancer Research (FNLCR) is a Federally Funded Research and Development Center sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. With more than 2,000 employees, the FNLCR is responsible for pursuing its public health service mission via translational and applied biomedical research that is unique from academia, the pharmaceutical industry, or other federal contractors.

There are excellent opportunities and support for collaborative research programs within the FNLCR and between the FNLCR and the NCI in developmental therapeutics, pharmacology, cancer genomics, computational biology, preclinical imaging, natural products, veterinary oncology, and solid and hematological malignancies and their preclinical models (including rare diseases and early passage patient-derived models). Outstanding core laboratories and an unparalleled environment for collaborations among basic, translational, and clinical scientists foster interdisciplinary research and translation of discoveries from the lab into the clinic.

The selected candidate will join the Clinical PD Biomarkers program, located at the NCI-Frederick campus.

The Clinical PD Biomarkers Program is responsible for identification of biomarkers of response to new targeted agents entering clinical trials in the Developmental Therapeutics Program of the National Cancer Institute. The scope of work includes assay design, development, validation, fitness for purpose testing, transfer of assays to clinical laboratories, and clinical specimen analysis when required. The program facilitates mechanistic evaluation of putative anti-cancer agents, diagnostic tests, and therapeutic interventions to facilitate clinical entry, including distinct molecular signatures for cancer, refined molecular assays, and state-of-the-art imaging techniques that are too high-risk for industry or academia to pursue.

The program operates a number of advanced, specialized instrumentation for measurement of multiplexed biomarkers, image analysis of tumor biopsies, circulating tumor cells, and activated T-cells for measuring drug effects in patients enrolled in phase 0 and 1 clinical trials.

• Develop multiplex immunoassays of de novo pharmacodynamic biomarkers on Luminex platform, write “standard operating procedures” (SOPs), perform analytical validation of assays, process assay data by appropriate data reduction and statistical methodologies and implement PD biomarker assays in preclinical and clinical studies.
• Independently perform complex assignments associated with all aspects of immunoassay development, method validation, data analysis and implementation; perform tissue culture experiments using cancer cell lines to demonstrate utility of pharmacodynamic biomarkers of investigational agents; troubleshoot day-to-day activity on multiplex immunoassays to meet/ensure required performance.
• Prepare and characterize reagents required for immunoassay development (antibody conjugates, calibrators, stabilizers etc.) to support Luminex assays for clinical and preclinical testing; design and prepare quality control materials from tumor models, animal tissues and cancer cell lines and qualify them for biomarker assays.
• Prepare progress reports for management, maintain all work-related documentation and deliver accurate, traceable results to the program leaders.

• Possession of a Bachelor’s degree in science, bioinformatics, or a related field…