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Medical Sciences Opportunities at PAREXEL

Medical Sciences

Quantitative Clinical Development (QCD) Director - Home Based

Job ID 44974BR Location United States
PAREXEL’s Quantitative Clinical Development (QCD) department provides expertise, across numerous therapeutic indications, in the strategic implementation of modeling & simulation services to drive drug development decision making. Our global team of experienced scientists offers unsurpassed expertise in Clinical PK/PD, Pharmacometrics, and Model-Based Drug Development (MBDD) from Translational Sciences for First Time in Human (FTIH) through all Phases of Drug Development to Marketed products.

Leverage your PK and PD expertise skills as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development at PAREXEL.
  • Analyze clinical PK/PD data as a member of multidisciplinary development program teams
  • Conduct population PK, PK/PD M&S analyses
  • Advise on the application of PK, PK/PD modeling and simulation to clients
  • Attend regulatory agency interactions
  • Assist clinical teams study in designing PK/PD components in all phases of clinical drug development such as first-in-human, POC, pediatric PK, bioequivalence, biosimilar and drug-drug interaction studies
  • Review scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans, Clinical Study Reports
  • Provide Quality Control (QC) for NCA and NONMEM analysis and derived data
  • Author and contribute to scientific publication

Qualifications

  • Excellent knowledge of PK and PD principles
  • Strong experience with the design and implementation of Model-Based Drug Development strategies
  • Expertise with Pharmacometric methodologies (e.g., disease modelling, conc-QT analysis, clinical trial simulation, etc.)
  • Experts with Modeling and Simulation Software (NONMEM, R, GastroPlus, Phoenix, etc.)
  • Relevant experience in clinical drug development of both NCEs and biologicals
  • Excellent verbal, written, presentation and organizational skills
Join a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. If you are inspired to make a difference in the world, apply now.

EEO Disclaimer

PAREXEL is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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