[Hiring] Principal PBPK Consultant @Certara

Role Description

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 such as 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.

Requirements

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

Benefits

Certara bases all employment-related decisions 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.