================= PAREXEL’s Quantitative Clinical Development 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.
We are looking for a motivated individual with an established track record in effectively applying clinical pharmacology principles and pharmacometric methodologies to aid worldwide clients’ rational and informed decision making in drug development. JOB DESCRIPTION • Analyze clinical PK/PD data as a member of multidisciplinary development program teams • Conducts population PK, PK/PD M&S analyses · Provide advice on the application of PK, PK/PD modeling and simulation to clients · Attend regulatory agency interactions as a project clinical pharmacometric representative • Assist clinical teams study design 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 of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports • Provide Quality Control (QC) for NCA and NONMEM analysis and derived data generated by PK Analyst • Author and contribute to scientific publications, REQUIRED SKILLS AND EXPERIENCE • 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, GastroPlus and R, Phoenix etc) • Relevant experience in clinical drug development of both NCEs and biologicals • Excellent verbal, written, presentation and organizational skills Interested individuals are encouraged to apply at the following link: https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=25617&siteid=5091&jobid=1227322 Hiring manager: Joseph Kim, PhD, Senior Director, Quantitative Clinical Development, PAREXEL, Durham Joseph Kim, PhD, RPh Senior Director, Quantitative Clinical Development PAREXEL International USA Next 000: June 7-8: Day off T +1 919.294.5167 M +1 919.265.9538 joseph....@parexel.com<mailto:joseph....@parexel.com> Kind regards, Laura Iavarone Scientific Director Quantitative Clinical Development PAREXEL International The Quays, 101-105 Oxford Road Uxbridge, Middlesex, UB8 1LZ, UK T +44 (0)1895 614933 M +44 (0)7917218143 laura.iavar...@parexel.com<mailto:laura.iavar...@parexel.com> www.PAREXEL.com<http://www.parexel.com/> This communication, including any attachments, is intended only for the person or entity to which it is addressed and may contain confidential material. Any review, retransmission, distribution or other use of this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please destroy any copies, contact the sender and delete the material from any computer. Thank you.
