Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head

About the role

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 Leidos Biomedical Research, Inc. 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. The laboratory is responsible for informing and supporting 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.

Responsibilities

• 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 hepatocytes, microsomal metabolic stability, reaction phenotyping using recombinant CYPs and UGTs, solubility, protein binding, and blood/plasma partitioning to better understand pharmacokinetic findings, as needed by clinical and preclinical drug development teams.
• Contribute to the discovery and analysis of pharmacokinetic/pharmacodynamic relationships in early clinical trial patients and animal models of cancer.
• Contribute to the biopharmaceutical understanding of how formulation and route of administration affect the dose-exposure relationship.
• Contribute to the selection of the optimal combination of dose-exposure-route-formulation to maximize treatment effect and therapeutic index. This activity may utilize in vitro bidirectional permeability studies using Caco2 cells or other ex vivo models of physiological barriers.
• Contribute to optimization of therapeutics via a focused effort in drug metabolism, drug delivery and transport, pharmacokinetics, and drug formulation.
• As the laboratory director and spokesperson, make important contributions at meetings between the NCI Developmental Therapeutics Clinic and its correlative sciences laboratories.
• As the laboratory director and spokesperson, make important contributions at meetings of drug development and discovery teams chartered by DCTD and led by internal NCI staff or extramural investigators from multiple institutions (Chemical Biology Consortium and the Experimental Therapeutics Clinical Trial Network for discovery and development, respectively).
• Author, or co-author, peer-reviewed manuscripts about important laboratory findings on public-facing projects.
• Manage productivity, performance, and priorities of the laboratory’s applied R&D program.
• Proactively manage the laboratory and its assets via participation in budgeting and project planning.
• Proactively assess new/emerging technologies and report to DCTD with recommendations on adoption in the Laboratory.
• Direct and coordinate the activities of the laboratory staff based on frequent review of results.

Qualifications

• Possession of a PhD, clinical doctorate (MD, PharmD, DVM), or equivalent degree in Clinical Pharmacology, Pharmacology, Toxicology, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biomedical/Biological Engineering, or a related Biomedical or Medical Science from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency.
• A minimum of two (2) years experience however (5) years related experience is preferred.
• Research interests in cancer, in particular an interest in translating laboratory discoveries into early clinical trial concepts.
• Productive postdoctoral experience and/or clinical fellowship that used pharmacokinetics in an area of drug development, such as Pharmacokinetics, Clinical Pharmacology, Biopharmaceutics, Drug Metabolism, Drug Delivery, Toxicology, etc.
• A noteworthy record of research accomplishment that demonstrate initiative.
• Achievements consistent with appointment at the Assistant Professor level or equivalent.
• Excellence in collaborative research; innovation and creativity when needed; managing and adhering to project and/or operating budgets; organizational, planning and time management skills; interpersonal skills; and verbal/written communication skills.
• More than one example of successful development of validated bioanalytical methods that were used for measuring drug levels in blood specimens.
• More than one successful experience determining drug and drug metabolite levels in blood samples from early clinical trial patients.
• More than one experience determining drug and drug metabolite levels in blood samples from animal models of cancer.
• More than one experience determining drug and drug metabolite levels in solid tissue specimens.
• Ability to obtain and maintain a security clearance.

Bonus Qualifications

• More than one example of successful development of a validated bioanalytical method that was used for measuring drug levels in solid tissue specimens.
• Minimum of one successful experience determining drug and drug metabolite levels in tumor specimens from patients with cancer or from animal models of cancer.
• At least one successful experience using ex vivo drug permeability and/or drug metabolism systems.
• A productive postdoctoral experience in an area of expertise relevant to oncology drug development and/or developmental therapeutics for cancer.
• Working knowledge in the use of pharmacokinetic/pharmacodynamic software including physiologically based pharmacokinetic (PBPK) and population pharmacokinetic modeling (PopPK).

Job Hazards

This position is subject to working with or having potential for exposure to animal(s) and/or animal material(s).

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