PK Scientist

The PK Scientist will ensure the strategic and operational 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 SBUs and clients.

Analyze clinical PK/PD data as a member of several multidisciplinary development program teamsWork with clinical teams to design PK/PD components in various study designs, such as first-in-human, bioequivalence and drug-drug interaction studiesContribute to clinical PK/PD sections of relevant documentsContribute to the design, analysis, reporting, and presentation of PK/PD modeling and simulation initiatives, including population PK/PD analyses for all phases of developmentReview of scientific documentation including Clinical Study Protocols, SOPs, Statistical Analysis Plans and Clinical Study ReportsMaintain a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceuticsDevelop and maintain a relationship with internal and external clients and scientistsReviewing/Authoring scientific publications, abstracts, postersProgram ManagementMaintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective mannerQualificationsSkills:Strong knowledge of PK and PD principlesExperience with the design and implementation of Model-Based Drug Development strategiesKnowledge of Pharmacometric methodologies and toolsExcellent interpersonal, verbal and written communication skillsStrong clinical/scientific writing skillsClient focused approach to work ethicExhibits and promotes a flexible attitude with respect to work assignments and new learningAbility to manage multiple and varied tasks with enthusiasmWillingness to work in a matrix environment and to value and promote the importance of teamwork.Advanced experience with Microsoft Office products including Word, PowerPoint, Excel

Knowledge and Experience:Experience in drug development desiredGood standard of written and spoken EnglishPreferred software experience: Pharsight Software (PKS/WinNonlin/Phoenix), NONMEM, GastroPlus, PKSim, RExperience in LaTex is beneficial

Education:Advanced science degree (MS, PharmD, PhD) and/or relevant experience