Translational Pharmacokinetics/ Biopharmaceutics Scientist and Laboratory Head

2 months ago

Frederick, United States Frederick National Laboratory for Cancer Research Full time

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 is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and 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 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.

#readytowork

  • Medical Laboratory Scientist

    1 week ago

    Frederick, Oklahoma, United States K.A. Recruiting Full time

    Job Overview: We are seeking a highly skilled Medical Laboratory Scientist to join our team at K.A. Recruiting. **Job Summary:** As a Medical Laboratory Scientist, you will be responsible for performing laboratory procedures in a prompt, accurate, and reliable manner. You will work under the general supervision of a Lab Supervisor and may be asked to...

  • Medical Laboratory Scientist in Maryland

    1 week ago

    Frederick, Maryland, United States K.A. Recruiting Full time

    Job Title: Medical Laboratory ScientistLocation: MarylandAbout the Role:We are seeking a skilled Medical Laboratory Scientist to join our team in Maryland. The successful candidate will be responsible for conducting laboratory tests to aid in patient diagnosis and treatment.Key Responsibilities:Conduct laboratory tests according to established...

  • Medical Laboratory Scientist

    4 weeks ago

    Frederick, Oklahoma, United States K.A. Recruiting Full time

    Job Summary:As a Medical Laboratory Scientist, you will perform laboratory procedures with precision and accuracy, adhering to established hospital and departmental policies and procedures. You may also be responsible for supervising a specific area within the laboratory department under the guidance of the Director of Laboratory.Key Responsibilities:Perform...

  • Biopharmaceutical Process Specialist

    2 weeks ago

    Frederick, Maryland, United States Piper Companies Full time

    Piper Companies is seeking a highly skilled Process Engineer to join their clinical biopharmaceuticals team in Frederick, MD.Key Responsibilities:Manage laboratory inventory, including consumables, reagents, and equipment.Perform nucleic acid extractions, such as DNA or RNA.Develop and maintain cell lines using cell culture techniques.Conduct various testing...

  • Medical Laboratory Scientist

    3 weeks ago

    Frederick, Oklahoma, United States KA Recruiting Inc. Full time

    Job Summary:As a Medical Laboratory Scientist, you will perform laboratory procedures with precision and accuracy, adhering to established hospital and departmental policies and procedures. Under the supervision of a Lab Supervisor, you will work independently and as part of a team to ensure the highest quality results.Key Responsibilities:Perform laboratory...

  • Senior Bioanalytical Scientist

    2 days ago

    Frederick, Maryland, United States Jobot Full time

    Senior Bioanalytical Scientist OpportunityThis Jobot Job is hosted by a global CRO that specializes in oncology and rare diseases.We are seeking a highly skilled Senior Bioanalytical Scientist to join our team in the pharmaceutical industry. The ideal candidate will have a robust background in method development for large molecules, particularly in the areas...

  • Senior Bioanalytical Research Scientist

    7 days ago

    Frederick, Maryland, United States Jobot Full time

    Senior Bioanalytical Research Scientist OpportunityThis is a challenging role for a highly skilled Senior Bioanalytical Research Scientist to join our team in the pharmaceutical industry. The ideal candidate will have a robust background in method development for large molecules, particularly in the areas of AD and PK. This role requires strong mentorship...

  • Associate Scientist I

    5 months ago

    Frederick, United States Frederick National Laboratory for Cancer Research Full time

    Associate Scientist I - Flow Cytometry Job ID: req3649Employee Type: exempt full-timeDivision: Applied & Development Research ProgramFacility: Frederick: Ft DetrickLocation: PO Box B, Frederick, MD 21702 USA The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and...

  • Bioanalytical Scientist

    1 week ago

    Frederick, United States Jobot Full time

    Job DescriptionJob DescriptionNEW Bioanalytical Scientist Opportunity!This Jobot Job is hosted by: Audrey BlockAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $80,000 - $100,000 per yearA bit about us:We are a well established, global CRO that works in oncology and rare diseases! We are hiring a...

  • Support Scientist

    2 weeks ago

    Frederick, Maryland, United States Alaka`ina Foundation Family of Companies Full time

    Job Title: Support ScientistWe are seeking a highly skilled Support Scientist to join our team at the Alaka`ina Foundation Family of Companies. As a Support Scientist, you will play a critical role in supporting scientific activities within the Molecular Virology and Microphysiological System's Group.Responsibilities:Plan, execute, and report scientific...

  • Laboratory Technician

    2 weeks ago

    Frederick, Maryland, United States StageBio Full time

    Job Title: Laboratory Technician IStageBio is a leading global provider of GLP-compliant clinical research and preclinical necropsy, histology, pathology, image analysis, and specimen archiving services for the biopharmaceutical, medical device, and contract research industries.Job Summary:We are seeking a full-time Laboratory Technician I to join our...

  • Support Scientist

    4 weeks ago

    Frederick, Maryland, United States Laulima Government Solutions Full time

    Job Title: Support ScientistWe are seeking a highly skilled Support Scientist to join our team at Laulima Government Solutions. As a Support Scientist, you will play a critical role in supporting scientific activities within our Molecular Virology and Microphysiological Systems Group.Responsibilities:Plan, execute, and report scientific activities in...

  • Flow Cytometry Scientist

    3 weeks ago

    Frederick, Maryland, United States Precision for Medicine Full time

    Job Title: Flow Cytometry ScientistPrecision for Medicine is a global leader in precision medicine clinical research services. We are seeking a highly skilled Flow Cytometry Scientist to join our team.Job Summary:The Flow Cytometry Scientist will be responsible for performing flow cytometry assays, designing and executing experiments, and analyzing data to...

  • Flow Cytometry Scientist

    2 weeks ago

    Frederick, Maryland, United States Precision for Medicine Full time

    Job Title: Flow Cytometry ScientistPrecision for Medicine is a global leader in precision medicine clinical research services, dedicated to improving the clinical research and development process for new therapeutics. Our innovative approach integrates clinical operations excellence, laboratory expertise, and advanced data sciences to inform every step. We...

  • Senior Research Scientist, Virology and Toxinology

    1 week ago

    Frederick, Maryland, United States Battelle National Biodefense Inst Full time

    Job SummaryWe are seeking a highly skilled Research Scientist to join our team at the Battelle National Biodefense Institute. The successful candidate will be responsible for conducting research in virology and toxinology, with a focus on addressing scientific knowledge gaps related to biological threats.The ideal candidate will have a strong background in a...

  • Medical Laboratory Specialist

    2 weeks ago

    Frederick, Oklahoma, United States K.A. Recruiting Full time

    Job Summary:As a Medical Laboratory Scientist, you will perform laboratory procedures with precision and accuracy, adhering to established hospital and departmental policies and procedures. You will work under the supervision of a Lab Supervisor and may be asked to assist the Director of Laboratory in supervising a specific area within the Lab department.Key...

  • Medical Laboratory Assistant

    7 days ago

    Frederick, Maryland, United States Frederick Health Full time

    Job SummaryAt Frederick Health, we are seeking a highly skilled and detail-oriented Laboratory Assistant to join our team. As a Laboratory Assistant, you will play a critical role in supporting the Core Lab supervisor and Medical Technologist/Medical Laboratory Scientist in receiving and processing specimens for diagnosis.Key Responsibilities:Receives and...

  • Medical Laboratory Specialist

    1 week ago

    Frederick, Maryland, United States Calvert Health System Full time

    Job SummaryWe are seeking a highly skilled Medical Technologist to join our team at Calvert Health System. As a Medical Technologist, you will be responsible for producing accurate results in various laboratory areas, including hematology, serology, chemistry, blood bank, coagulation, urinalysis, and microbiology.Key ResponsibilitiesProduce accurate results...

  • Associate Project Director, Translational Services

    1 month ago

    Frederick, Maryland, United States Precision Medicine Group Full time

    Job Title: Associate Project Director, Translational ServicesJoin Precision Medicine Group as an Associate Project Director, Translational Services, and play a key role in leading new and existing CRO laboratory projects across various disciplines. This role will focus on accelerating the development and adoption of novel therapeutics, including assay...

  • Support Scientist

    4 weeks ago

    Frederick, Maryland, United States Alaka`ina Foundation Family of Companies Full time

    Job Title: Support ScientistWe are seeking a highly skilled Support Scientist to join our team at the Alaka`ina Foundation Family of Companies. As a Support Scientist, you will play a critical role in supporting scientific activities within our Molecular Virology and Microphysiological System's Group.Key Responsibilities:Plan, execute, and report scientific...