Translational Pharmacokinetics​/Biopharmaceutics Scientist and Laboratory Head

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 (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by a prime contractor, which currently is 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 for this position (Leidos Biomedical Inc hiring level of Scientist‑2) will direct the FNLCR’s Pharmacokinetics & Biopharmaceutics Research Laboratory located at the NCI‑Frederick campus in its mission to inform and support drug discovery and development, translational drug mechanism of action studies, and clinical trial programs of the NCI Division of Cancer Treatment and Diagnosis (DCTD) via R&D activities in bioanalytical chemistry, drug level analyses, pharmacokinetic modeling, and biopharmaceutical studies.

Success in this role will require knowledge of pharmacology, ADME (absorption, distribution, metabolism, elimination), biopharmaceutics, and drug development (preferably in oncology) as well as experience with wide‑ranging bioanalytical methods and experimental approaches.

• Develop, propose, and upon DCTD approval implement approaches to create an applied R&D program in pharmacokinetics and biopharmaceutics that is valuable to DCTD scientific programs in drug discovery, drug development and early clinical trials, including ongoing short‑term and long‑term strategic planning in coordination with DCTD.
• Direct the selection, development, and validation of a portfolio of bioanalytical methods for quantifying drug levels and their metabolites in blood and tissue specimens, including tumor specimens.
• Implement validated bioanalytical methods, with relevant and appropriate turn‑around times, to measure levels of experimental drugs and their metabolites in blood and tissue specimens, including tumor specimens, from early clinical trial patients and animal models of cancer.
• Characterize the drug metabolism‑pharmacokinetics (DMPK) of experimental anti‑cancer compounds in terms of Absorption, Distribution, Metabolism, and Excretion (ADME).
• Use measured drug levels in blood and tissue specimens for pharmacokinetic modeling and the derivation of key pharmacokinetic parameters, such as CMAX, initial and terminal phase half‑lives, clearance, exposure (AUC, time above threshold, etc), and route of elimination.
• Use the derived pharmacokinetic values to inform clinical and preclinical drug development teams about optimal dosage regimens, including dose scheduling, based on mechanisms of action.
• Conduct periodic drug‑drug interactions studies including in vitro CYP and UGT inhibition, CYP induction profiling using primary…