Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head

Job ID: req4080

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 for Cancer Research 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 Applied and Developmental Research Directorate provides essential clinical and biological monitoring, regulatory support, biospecimen processing and storage, assay development, and regulatory and project management at the Frederick National Laboratory. We support the intramural and extramural communities through clinical and laboratory monitoring of clinical trials, regulatory support, and biospecimen storage.  

The Frederick National Laboratory for Cancer Research (FNLCR) is responsible for pursuing its public health service mission via translational and applied biomedical research that is unique from academia and the pharmaceutical industry. There are excellent opportunities and support for collaboration 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 will direct the FNLCR’s PharmacokinetiBiopharmaceutics Research Laboratory Frederick, Maryland, its mission to inform and support drug discovery and development, translational drug mechanism of action studies, and clinical trial programs via R&D activities in bioanalytical chemistry, drug level analyses, pharmacokinetic modeling, and biopharmaceutical studies. 

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.
• 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.
  
  

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 of progressively responsible experience.
• 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 successful 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:

• Five (5) years related experience beyond the educational requirements.
• More than one example of successful development of a validated bioanalytical method that was used for measuring drug levels in solid tissue specimens.
• At least 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 Diversity

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, 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.

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