Principal PBPK Consultant
Job description
A PBPK modelling scientist role in Certara's PBPK consultancy team, developing and applying Simcyp-based PBPK/PBBM models to support client drug development programs from discovery to regulatory filing. The role involves leading consultancy projects and acting as a scientific subject matter expert.
At a glance
- Work mode
- Remote
What you'll do
- Plan, develop and apply PBPK/PBBM models to address a wide range of modelling questions first-in-human dose, DDI liability, food effect, special populations and biopharmaceutics prediction in line with appropriate regulatory guidance
- Lead and support all aspects of PBPK/PBBM projects Conduct data reviews, write modeling analysis plans and PBPK/PBBM modeling reports
- Contribute to regulatory interactions and reviews for client projects
- Act as subject matter expert for business development activities to bring in new PBPK/PBBM business (depending on experience)
- Keep abreast of the latest scientific developments in PBPK/PBBM to enable effective communication with colleagues, clients and the wider scientific community
- Engage with potential and existing clients on a regular basis
- Conduct quality control and scientific review of other PBPK scientists' work
- Contribute to PBPK/PBBM consulting and other Certara scientific and business initiatives
- Maintain a high profile in the scientific community — publish work, give talks at scientific meetings and engage in scientific debate with clients
What we're looking for
- A PhD degree in a relevant field or equivalent experience in IVIVE/drug metabolism/pharmacokinetics
- 7 years+ of experience in the field of PBPK/PBBM modelling
- In-depth knowledge and practical experience of the application of PBPK modelling in the drug discovery and development process and awareness of its acceptance across various regulatory bodies
- In-depth knowledge and understanding of IVIVE/drug metabolism/pharmacokinetics
- Demonstrable experience with the leading PBPK/PBBM modeling platforms, ideally including Simcyp®
- Excellent oral and written communication skills to effectively engage with peers and clients within industry, academia and regulatory agencies
Nice to have
- Previous consulting experience
- Data analytics and programming skills using R
- Application of AI skills to PBPK/PBBM and consulting workflows
Your team
Certara PBPK consultancy team
A global organization focused on using the Simcyp® physiologically-based pharmacokinetic (PBPK) and physiologically-based biopharmaceutics modeling platform to influence decision making on drug development programs from discovery to regulatory filing; the largest PBPK/PBBM consulting team in the industry.
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About Certara
Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI.
Mission
To enable the life sciences industry's use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development.
Key facts
- Biosimulation software, technology, and services for the life sciences industry
- Clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries
- Largest PBPK/PBBM consulting team in the industry