Principal PBPK 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

Overview

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 clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

Our goal is 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. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.

About the Team

The Certara PBPK consultancy team is 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. We are the largest PBPK/PBBM consulting team in the industry, and our consultants work with hundreds of clients to inform human PK prediction, drug-drug interaction assessment, special population predictions and biopharmaceutics applications.

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/PBBM models to understand and impact drug discovery and development questions.

Successful candidates will join an internationally recognized, 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 programs.

Please note: The post does not include routine laboratory or clinical work.

Responsibilities

The role involves contributing to and leading (depending on experience) consultancy projects with clients in the Pharmaceutical Industry to develop PBPK models. Specific responsibilities include:

• 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

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
• 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

Desired

• Previous consulting experience
• Data analytics and programming skills using R.
• Application of AI skills to PBPK/PBBM and consulting workflows

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.