Please can you post the below? Thanks! Laura
Parexel has a new home based opportunity for an Associate Director, Clinical Pharmacology, Modelling & Simulation. The Associate Director ensures the strategic application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development. Individuals will provide support for PK/PD strategy and interpretation to other parexel internal Strategic Business Unit and clients. The Associate Director will provide quality services to clients. Key Accountabilities: * To analyze clinical PK/PD data as a member of several multidisciplinary development program teams. * To work with clinical teams to design PK/PD components in various study designs such as first-in-human, bioequivalence and drug-drug interaction studies. * 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 PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of development. * Review of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study Reports. * Provides Quality Control (QC) for WinNonlin and NONMEM analysis. * Review of derived PK/PD data generated by PK Analyst. * Maintaining a strong working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics. * Developing and maintaining a relationship with internal and external clients and scientists. * Provides leadership and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives. * Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner. * To provide scientific support and advice to relevant Parexel staff. * Provide training and guidance and act as a mentor to less experienced departmental members. * Reviewing/Authoring scientific publications, abstracts, posters. Skills: * Excellent knowledge of PK and PD principles. * Strong experience with the design and implementation of Model-Based Drug Development strategies. * Knowledge of Pharmacometric methodologies (e.g., conc-QT analysis, clinical trial simulation) * Experience in basic PK analysis tool such as WinNonlin/Phoenix * Experience in other software such as NONMEM, GastroPlus and R is desirable. * Experience in clinical drug development of both NCEs and biologicals. * Excellent interpersonal, verbal and written communication skills. * Strong clinical/scientific writing skills. * Client focused approach to work ethic. * Exhibits and promotes a flexible attitude with respect to work assignments and new learning. * Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail. * Willingness to work in a matrix environment and to value and promote the importance of teamwork. * Demonstrated understanding of the drug development process and a knowledge of FDA and EMEA guidelines. Knowledge and Experience: * Typically 6-10 years' experience in drug development. Education: * Advanced science degree (PhD, PharmD) and/or relevant experience. Please apply via the link below. https://jobs.parexel.com/job/united-kingdom/associate-director-clinical-pharmacology-modelling-and-simulation/877/16940182 Thank you Laura Iavarone Scientific Director Clinical Pharmacology, Modeling & Simulation 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>
