*Duke Clinical Research Institute Pharmacometrics Center of Excellence * *Pharmacokineticist Position Opening*
*Summary* The ideal candidate will provide support in the design and preparation of clinical pharmacokinetics development strategies and study protocols, performing pharmacokinetic (PK) and pharmacodynamic (PD) analyses, and preparation of clinical study reports and integrated summary documents. You will conduct and coordinate the PK/PD analysis or statistical efforts for clinical trials at all stages of drug development. *Work Performed* Application of PK/PD techniques during all stages of drug development, including molecule selection, non-clinical dose and regimen selection, first-in-human studies, Phase II dose/regimen selection, and strategic and tactical decision-making for large Phase III clinical studies. There will be a focus on the evaluation and implementation of innovative trial designs to enhance the efficiency and provide better informed decision-making. Design, planning, and execution of basic biostatistical components of plans for research and development projects of early-phase clinical studies, including summary statistics of clinical variables and basic inferential statistics. Evaluation and understanding of PK/PD characteristics absorption, distribution, metabolism, and excretion (ADME) research on compounds, and associated variability of drugs in clinical development, using empiric, mechanistic, and population modeling approaches. The ideal candidate will embrace model-based drug development (MBDD)—a mathematical and statistical approach that constructs, validates, and utilizes disease, placebo, exposure-response, and pharmacometric models to evaluate risk and facilitate drug development, in close collaboration with R&D partners. *Education/Training:* - Work requires a minimum of a PharmD, MD, PhD in pharmaceutical sciences or pharmacology. - Graduation from an accredited postdoctoral clinical pharmacology program. - Or an equivalent combination of relevant education and/or experience. *Experience:* - Proficient in PK/PD or related analyses and extensive knowledge of and hands-on familiarity with software such as winnonlin and NONMEM software required. - Ability to assemble and format data using programs such as R, SAS, Stata is a plus. To learn more about Duke Clinical Research Institute, please go to https://www.dcri.org/ If interested, please contact our group manager Anthony Cunningham < anthony.cunning...@duke.edu>
