Pharmacometrician position at Sanofi

From: Christine Veyrat-Follet Date: November 05, 2014 job Source: mail-archive.com
Dear all, The Disposition, Safety & Animal Research Department from Sanofi R&D is seeking for a pharmacometrician within the Modeling & Simulation Unit of Paris operational center. The candidate will have the following missions: * Accountable for the development and implementation of a clinical modeling and simulation plan based on agreed upon best practices (i.e. model-based drug development). * Responsible for designing and analyzing the pharmacokinetic and pharmacodynamic components (population PK, PK/PD) of clinical trials in all phases of development. * Working and communicating effectively with people from diverse scientific backgrounds in multi-disciplinary development teams providing pharmacometric/modeling expertise in different therapeutic areas. * Ensuring quality of the study protocols, reports, sections of reports (e.g., INDs and NDAs) required for regulatory submissions to various health authorities (e.g., the FDA and EMEA), summaries and publications. * Implementing innovative quantitative methods to integrate data of pharmacokinetics, biomarkers, and clinical outcome with data of patient characteristics and knowledge of disease mechanisms and disease states to facilitate quantitative decision making. * Working in compliance with good clinical Practice (GCP) regulations and guidance of regulatory authorities. Qualifications Requirements/Skills * PhD in relevant scientific discipline and demonstrated expertise in pharmacometrics and strong quantitative skills (e.g. experience in mechanistic modelling/systems pharmacology, quantitative translational scaling, population modelling). * Understanding of DMPK and pharmacology/ safety aspects of drug discovery and clinical development, and of basic statistics. * At least 5 years of experience on modelling and simulation in drug development in the pharmaceutical industry * Excellent written and verbal communication skills, with successful presentation capabilities. * Excellent team work and strong communication in a multidisciplinary environment * Innovative and critical thinking. Customer focus. * Languages: French and fluent English (oral and written) To apply, please send your CV with references and a letter of motivation to [email protected]<mailto:[email protected]> or [email protected]<mailto:[email protected]> or [email protected]<mailto:[email protected]> or directly apply on the Sanofi website. Christine Veyrat-Follet, PhD Sanofi Head of M&S group Paris