Senior PBPK Consultant

7 days ago

Wayne, United States Certara USA, Inc. Full time
Overview

About Certara

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 Simcyp 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.

We are seeking highly motivated and talented PBPK modelling scientists and experts with a DMPK, PBPK and/or a biopharmaceutics modelling background who share our passion for using PBPK models to understand and impact drug discovery and development questions.

The successful candidate will join an internationally recognised, multidisciplinary company, providing opportunities for further development of knowledge and skills. We offer a unique and exciting mix of academic and commercial environments which encourage regular attendance at scientific meetings as part of our continuous education programmes.

The post does not include routine laboratory or clinical work.


Responsibilities

The role involves contributing to consultancy projects with clients in the Pharmaceutical Industry to develop PBPK models for particular projects of interest.

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.
  • You will lead consultancy projects (model development, verification and application) or contribute to consultancy projects with minimal supervision.
  • You will need to keep abreast of the latest scientific development in the area of 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 the field of IVIVE/ drug metabolism/ pharmacokinetics.
  • 5 years of experience in the field of IVIVE/drug metabolism/Pharmacokinetics.
  • Should have knowledge of the application of PBPK modelling in the drug discovery and development process.
  • Has a sound knowledge and understanding of IVIVE/ drug metabolism/ pharmacokinetics.
  • Should have a good 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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