Principal PBPK Consultant

Certara•UNAVAILABLE, UNAVAILABLE

About The Position

Certara is seeking an experienced PBPK modelling scientist to contribute to and lead client consultancy projects in the pharmaceutical industry. The role uses the Simcyp® PBPK and PBBM platform to address drug discovery and development questions, including human pharmacokinetic prediction, drug–drug interaction assessment, special-population predictions, and biopharmaceutics applications. The position combines scientific consulting with client engagement, regulatory support, scientific review, and business development. It does not include routine laboratory or clinical work.

Requirements

PhD in a relevant field, or equivalent experience in IVIVE, drug metabolism, or pharmacokinetics.
At least 7 years of experience in PBPK/PBBM modelling.
In-depth knowledge and practical experience applying PBPK modelling in drug discovery and development, and awareness of its acceptance across regulatory bodies.
In-depth knowledge and understanding of IVIVE, drug metabolism, and pharmacokinetics.
Demonstrable experience with leading PBPK/PBBM modeling platforms, ideally including Simcyp®.
Excellent oral and written communication skills for engaging with peers and clients in industry, academia, and regulatory agencies.

Nice To Haves

Previous consulting experience.
Data analytics and programming skills using R.
Experience applying AI to PBPK/PBBM and consulting workflows.

Responsibilities

Plan, develop, and apply PBPK/PBBM models to address questions such as first-in-human dose, drug–drug interaction 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 and write modeling analysis plans and PBPK/PBBM modeling reports.
Contribute to regulatory interactions and reviews for client projects.
Depending on experience, act as a subject matter expert in business development to bring in new PBPK/PBBM business.
Keep abreast of scientific developments in PBPK/PBBM and communicate effectively with colleagues, clients, and the wider scientific community.
Engage regularly with potential and existing clients.
Conduct quality control and scientific review of other PBPK scientists’ work.
Contribute to PBPK/PBBM consulting and other Certara scientific and business initiatives.
Publish work, give talks at scientific meetings, and engage in scientific debate with clients to maintain a high profile in the scientific community.