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Certara USA, Inc.

Principal PBPK Consultant

Certara USA, Inc., Upton, New York, United States

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Overview

Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries. In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies. The Certara Predictive Technologies PBPK consultancy team is a global organisation focussed on using the Simcyp physiologically-based pharmacokinetic (PBPK) platform to influence decision making on drug development programs from discovery to regulatory filing. Our PBPK consultants work with 100s of clients to inform human PK prediction, drug-drug interaction assessment, special population predictions and biopharmaceutics strategy. The role does not include routine laboratory or clinical work. The role involves contributing to consultancy projects with clients in the Pharmaceutical Industry to develop PBPK models for particular projects of interest. Responsibilities

Apply PBPK models in support of a number of applications including but not limited to the following: DDI liability prediction Food effect prediction PK prediction in special populations Biopharmaceutics/bioequivalence prediction Large molecule PK prediction Contribute to consultancy projects with supervision Keep abreast of the latest scientific development in PBPK and IVIVE to enable effective communication with colleagues, clients and the wider scientific community Qualifications

A PhD degree in a relevant field or equivalent experience in IVIVE/drug metabolism/pharmacokinetics Should have some knowledge of the application of PBPK modelling in the drug discovery and development process Has knowledge and understanding of IVIVE/drug metabolism/pharmacokinetics Should have a sound overview of the simulator with good knowledge and understanding of specific areas Excellent communication skills to effectively engage with peers and clients within industry, academia and regulatory agencies Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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