Senior PBPK Modeling Consultant

Certara USA, Inc.; Upton (PA); On-site; USD 120,000 - 180,000; Full time

Job summary

Certara USA, Inc. in the United States seeks a senior PBPK/PBBM modelling scientist to lead consultancy projects from discovery to regulatory filing.

You will develop and apply PBPK models, work with pharma clients, and guide analyses from study design to reporting. The role emphasizes collaboration with biopharmaceutics specialists, data analytics using R, and ongoing contribution to scientific publications and business development.

Qualifications

• 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.
• 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.

Responsibilities

• Plan, develop and apply PBPK/PBBM models to address modelling questions per regulatory guidance.
• Lead and support PBPK/PBBM projects; conduct reviews and write modeling reports.
• Contribute to regulatory interactions and reviews for client projects.
• Act as subject matter expert for business development to bring in PBPK/PBBM work.
• Stay updated on PBPK/PBBM developments and engage with clients and the scientific community.
• Engage with potential and existing clients regularly and contribute to consulting initiatives.

Skills

PBPK/PBBM modelling expertise

Regulatory knowledge

Oral and written communication skills

R programming basics

Education

PhD in a relevant field (IVIVE, PK/ADME)

Tools

Simcyp

Job description

Certara USA, Inc. in the United States seeks a senior PBPK/PBBM modelling scientist to lead consultancy projects from discovery to regulatory filing.

You will develop and apply PBPK models, work with pharma clients, and guide analyses from study design to reporting. The role emphasizes collaboration with biopharmaceutics specialists, data analytics using R, and ongoing contribution to scientific publications and business development.