Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head
Location: Frederick
Posted on: June 23, 2025
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Job Description:
Translational Pharmacokinetics/ Biopharmaceutics Scientist and
Laboratory Head Job ID: req4313 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. PROGRAM DESCRIPTION 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. KEY
ROLES/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. BASIC QUALIFICATIONS To be
considered for this position, you must minimally meet the
knowledge, skills, and abilities listed below: 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 QUALIFICATIONS Candidates
with these desired skills will be given preferential consideration:
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 have potential for exposure to animal(s)
and/or animal material(s). This position is subject to working with
or have potential for exposure to infectious material, requiring
medical clearance and immunizations. Commitment to
Non-Discrimination All qualified applicants will receive
consideration for employment without regard to sex, race,
ethnicity, color, age, national origin, citizenship, religion,
physical or mental disability, medical condition, genetic
information, pregnancy, family structure, marital status, ancestry,
domestic partner status, sexual orientation, gender identity or
expression, veteran or military status, or any other basis
prohibited by law. Leidos will also consider for employment
qualified applicants with criminal histories consistent with
relevant laws. Pay and Benefits Pay and benefits are fundamental to
any career decision. That's why we craft compensation packages that
reflect the importance of the work we do for our customers.
Employment benefits include competitive compensation, Health and
Wellness programs, Income Protection, Paid Leave and Retirement.
More details are available here 100,400.00 - 172,625.00 The posted
pay range for this job is a general guideline and not a guarantee
of compensation or salary. Additional factors considered in
extending an offer include, but are not limited to,
responsibilities of the job, education, experience, knowledge,
skills, and abilities as well as internal equity, and alignment
with market data. The salary range posted is a full-time equivalent
salary and will vary depending on scheduled hours for part time
positions
Keywords: , Arlington , Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head, Science, Research & Development , Frederick, Virginia