Translational Pharmacokinetics​/Biopharmaceutics Scientist and Laboratory Head

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 urgent and intractable problems in biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, nanotechnology applications in medicine, and rapid response to emerging infectious disease threats.

FNLCR is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research. With more than 2,000 employees, FNLCR pursues its public health mission through translational and applied biomedical research unique from academia, industry, or other federal contractors. The laboratory supports collaborative research programs within FNLCR and between FNLCR and the NCI in developmental therapeutics, pharmacology, cancer genomics, computational biology, preclinical imaging, natural products, veterinary oncology, solid and hematological malignancies, and rare diseases.

The selected candidate (Leidos Biomedical Inc hiring level of Scientist-2) will direct the FNLCR’s Pharmacokinetics & Biopharmaceutics Research Laboratory located at the NCI-Frederick campus. Responsibilities include 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) through bioanalytical chemistry, drug level analyses, pharmacokinetic modeling, and biopharmaceutical studies.

Success requires knowledge of pharmacology, ADME, biopharmaceutics, and drug development (preferably in oncology) as well as experience with wide-ranging bioanalytical methods and experimental approaches.

• Develop, propose, and implement approaches to create an applied R&D program in pharmacokinetics and biopharmaceutics that supports DCTD scientific programs in drug discovery, drug development, and early clinical trials, coordinating short-term and long-term strategic planning.
• Direct the selection, development, and validation of a portfolio of bioanalytical methods for quantifying drug levels and metabolites in blood, tissue, and tumor specimens.
• Implement validated bioanalytical methods with appropriate turn‑around times to measure levels of experimental drugs and metabolites in blood, tissue, and tumor specimens from early clinical trial patients and animal cancer models.
• Characterize the drug metabolism‑pharmacokinetics (DMPK) of experimental anti‑cancer compounds in terms of ADME.
• Use measured drug levels to perform pharmacokinetic modeling and derive key parameters such as CMAX, half‑lives, clearance, exposure (AUC, time above threshold, etc.), and route of elimination.
• Use pharmacokinetic values to inform clinical and preclinical teams about optimal dosage regimens and scheduling based on mechanisms of action.
• Conduct periodic drug‑drug interaction studies including in‑vitro CYP and UGT inhibition, CYP induction profiling, microsomal metabolic stability, reaction phenotyping with recombinant CYPs and UGTs, solubility, protein binding, and blood/plasma partitioning.
• Contribute to the discovery and analysis of PK/PD relationships in early clinical trial patients and animal models.
• Contribute to biopharmaceutical understanding of how formulation and route affect the dose‑exposure relationship.
• Contribute to selecting the optimal combination of dose, exposure, route, and formulation to maximize treatment effect and therapeutic index, potentially using Caco‑2 or other ex‑vivo permeability studies.
• Optimize therapeutics through focused efforts in drug metabolism, delivery, transport, pharmacokinetics, and formulation.
• Serve as laboratory director and spokesperson, contributing to meetings between the NCI Developmental Therapeutics Clinic and its correlative sciences laboratories.
• Serve as laboratory director and spokesperson at meetings of drug development and discovery teams chartered by DCTD…