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 Overview 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 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. Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way. Program Description FNLCR collaborates with the NCI and supports core laboratories in developmental therapeutics, pharmacology, cancer genomics, computational biology, preclinical imaging, natural products, veterinary oncology, and solid and hematological malignancies. 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 to support drug discovery, translational drug mechanism studies, and clinical trials through bioanalytical chemistry, drug level analyses, pharmacokinetic modeling, and biopharmaceutical studies. Key Roles/Responsibilities Develop and implement an applied R&D program in pharmacokinetics and biopharmaceutics aligned with DCTD scientific programs. Direct the selection, development, and validation of bioanalytical methods for quantifying drug levels and metabolites in blood, tissue, and tumor specimens. Implement validated methods with appropriate turn‑around times to measure drug levels in early clinical trial patients and animal models. Characterize the drug metabolism‑pharmacokinetics (DMPK) of experimental anti‑cancer compounds in terms of ADME. Use measured drug levels for pharmacokinetic modeling and derive key parameters such as C MAX , half‑lives, clearance, exposure (AUC), and elimination routes. Inform clinical and preclinical teams about optimal dosage regimens, including dose scheduling based on mechanisms of action. Conduct periodic drug‑drug interaction studies, including in‑vitro CYP and UGT inhibition, CYP induction profiling, metabolic stability, reaction phenotyping, solubility, protein binding, and blood/plasma partitioning. Contribute to the discovery and analysis of pharmacokinetic/pharmacodynamic relationships in early clinical trial patients and animal models. Contribute to the biopharmaceutical understanding of how formulation and route of administration affect dose‑exposure relationships. Contribute to selecting the optimal combination of dose‑exposure‑route‑formulation to maximize treatment effect and therapeutic index, including in‑vitro permeability studies. Advance therapeutics via focused efforts in drug metabolism, delivery, transport, pharmacokinetics, and formulation. Serve as laboratory director and spokesperson at meetings with the NCI Developmental Therapeutics Clinic and other drug development teams. Author or co‑author peer‑reviewed manuscripts on laboratory findings. Manage productivity, performance, and priorities of the laboratory’s applied R&D program. Co‑manage laboratory budgeting and project planning. Assess emerging technologies and report recommendations to DCTD. Direct and coordinate laboratory staff activities based on frequent result reviews. Basic Qualifications PhD, clinical doctorate (MD, PharmD, DVM), or equivalent in Clinical Pharmacology, Pharmacology, Toxicology, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biomedical/Biological Engineering, or related biomedical or medical science. Minimum of 2 years (preferably 5 years) of related experience. Research interests in cancer, particularly translation of discoveries into early clinical trial concepts. Productive postdoctoral experience or clinical fellowship using pharmacokinetics in drug development. Noteworthy record of research accomplishment demonstrating initiative. Track record of professional achievements consistent with an Assistant Professor level or equivalent. Excellence in collaborative research, innovation, project budgeting, organizational, planning, time management, interpersonal, and written communication skills. Multiple successful examples of validated bioanalytical method development for drug level measurement in blood and solid tissue specimens. Multiple successful experiences determining drug and metabolite levels in patient and animal blood samples. Experienced in determining drug and metabolite levels in solid tissue specimens. Ability to obtain and maintain a security clearance. Preferred Qualifications Multiple successful examples of validated bioanalytical method development for solid tissue specimens. Minimum one successful experience determining drug metabolites in tumor specimens from patients or animal models. Experience using ex vivo drug permeability or metabolism systems. Productive postdoctoral experience in oncology drug development or developmental therapeutics. Working knowledge of PK/PD software including PBPK and PopPK. Job Hazards Potential exposure to animals and animal materials. Potential exposure to infectious materials, 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. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here. Pay range: $100,400.00 – $172,625.00 The posted pay range is a general guideline and not a guarantee of compensation. Additional factors considered include responsibilities, education, experience, and market data. The salary range posted is a full‑time equivalent salary and will vary depending on scheduled hours for part‑time positions. #J-18808-Ljbffr Frederick National Laboratory for Cancer Research