Clinical Pharmacology Modeling and Simulation, 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 for client projects. Key responsibilities include:

Analyze clinical PK/PD data as a member of several multidisciplinary development program teams

• Work with clinical teams to design PK/PD components in various study designs, such as first-in-human, bioequivalence and drug-drug interaction studies

• Contribute to clinical PK/PD sections of relevant documents

• Contribute to 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

• Develop a working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics

• Develop and maintain a relationship with internal and external clients and scientists

• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, and communicating to the team in an open, balanced and objective manner

• Reviewing/Authoring scientific publications, abstracts, postersQualificationsBeginner knowledge of PK and PD principles

• Experience with the design and implementation of Model-Based Drug Development strategies desired

• Knowledge of Pharmacometric methodologies and tools

• 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

• Willingness to work in a matrix environment and to value and promote the importance of teamwork.

• Experience with Microsoft Office products including Word, PowerPoint, Excel

Knowledge and Experience:

• Experience in drug development desired

• Good standard of written and spoken English

• Preferred software experience: Pharsight Software (PKS/WinNonlin/Phoenix), NONMEM, GastroPlus, PKSim, R

• Experience in LaTex is beneficial

Education:

• Advanced