Frederick National Laboratory for Cancer Research · 1 month ago
Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head
Frederick, MD
Full-time
Onsite
Mid, Senior Level
$100K/yr - $173K/yr
2+ years expThe Frederick National Laboratory for Cancer Research is a leading research facility focused on addressing critical challenges in biomedical sciences, particularly in cancer and AIDS. The role involves directing the Pharmacokinetics & Biopharmaceutics Research Laboratory, where the selected candidate will implement research and development activities to support drug discovery and clinical trial programs.
BiotechnologyHealth CareMedicalOncology
No H1B
Security Clearance Required
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
Qualification
Required
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
In addition to the education requirement, a minimum of two (2) years experience however (5) years related experience is preferred
Have research interests in cancer, in particular an interest in translating laboratory discoveries into early clinical trial concepts
Have had 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
Have a noteworthy record of research accomplishment that demonstrate initiative
Have a track record of professional achievements consistent with appointment at the Assistant Professor level or equivalent
Have exhibited 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
Have more than one example of successful development of validated bioanalytical methods that were used for measuring drug levels in blood specimens
Have more than one successful experience determining drug and drug metabolite levels in blood samples from early clinical trial patients
Have more than one experience determining drug and drug metabolite levels in blood samples from animal models of cancer
Have an example of successful development of a validated bioanalytical method that was used for measuring drug levels in solid tissue specimens
Ability to obtain and maintain a security clearance
Preferred
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)
Benefits
Competitive compensation
Health and Wellness programs
Income Protection
Paid Leave
Retirement
Company
Frederick National Laboratory for Cancer Research
Frederick National Laboratory for Cancer Research specializes in developing biomedical research and technology to improve human health.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Amanda Brooks
Talent Acquisition Partner
Betsy Day
Learning and Development Partner
Recent News
2025-10-14
2025-09-29
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