Company: PAREXEL Job Title: Principle Pharmacokinetic Scientist Department: Scientific Services - Clinical PK/PD and Pharmacometrics Location: UK, Uxbridge and US, East Coast Essential Function Primary role of the PK Scientist
* Provision of support to clinical study design and the analysis and interpretation of PK and PD data for Early Phase studies. * Provide consultative support for PK data interpretation to other SBUs and clients Key Accountabilities: * To analyze clinical PK/PD data as a member of several multidisciplinary development program teams. * To work with our clinical team to design PK components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies. The selected individual will be responsible for authoring or contributing to clinical PK/PD sections of relevant documents. * Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of sophisticated pharmacokinetic and pharmacodynamic modelling and simulation initiatives, including population pharmacokinetic/pharmacodynamic analyses for both phase I and late phase clinical trials * To provide training and scientific support and advice to all Early Phase staff * Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports * Quality control of pharmacokinetic output from WinNonlin analysis * Review of derived PK data generated by PK Analyst * To attend client meetings and represent PK/PD aspects as needed Skills: * Strong Knowledge of drug pharmacokinetics * Experience in Pharsight Software (WinNonlin/Phoenix) * Understanding of pharmacokinetic, and PK/PD modelling strategies * Experience in other software such as NONMEM, S-PLUS (population pharmacokinetics) * Experience in early clinical drug development of both NCEs and biologicals Education: * Science degree or preferably higher scientific qualification Language Skills * Good standard of written and spoken English Desired Work Experience * 5+ years in Clinical Pharmacology, 5+ years pharmacokinetics experience For more information visit http://sh.webhire.com/servlet/av/jd?ai=206&ji=2641743&sn=I Please contact Jon Gibbs for more details; Jon Gibbs PAREXEL International The Quays 101-105 Oxford Road Uxbridge Middlesex UB8 1LZ Email: [email protected]<mailto:[email protected]> Direct: +44(0)1895 614968
