Director – PBPK/PBBM Consultancy - Biopharmaceutics

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 consultancy team in the industry, and our PBPK/PBBM consultants work with hundreds of clients to inform human PK prediction, drug-drug interaction assessment, recruitment and dose adjustments in specific population predictions and biopharmaceutics application including biowaiver, virtual bioequivalence and formulation bridging.

We are seeking a highly motivated, experienced and talented PBPK/PBBM modelling scientist to lead and drive our biopharmaceutics modeling strategy and business.

The successful candidate 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

Reporting to the Senior Vice President of PBPK Consulting, the role involves leading consultancy projects with clients in the Pharmaceutical Industry to develop PBPK models primarily for biopharmaceutics applications. Specific responsibilities include:

• Leading biopharmaceutics modeling team of PBPK/PBBM scientists
• Drive biopharmaceutics modeling business strategy
• Act as lead consultant across biopharmaceutics and other PBPK modeling projects
• Oversee work performed by others in your team, including reviewing modelling work, regulatory responses and developing modelling and simulation plans
• Act as a biopharmaceutics subject matter expert for business development to generate new business clients and maintain existing client relationships
• Lead and contribute to scientific engagement and marketing activities in field of biopharmaceutics and PBPK modeling
• Be a contributing member of the PBPK consulting leadership team
• Keep abreast of the latest scientific developments in PBPK/PBBM communication with colleagues, clients and the wider scientific community
• Oversee work performed by others in your team, including reviewing modelling work, regulatory responses and developing modelling and simulation plans
• Grow and mentor the biopharmaceutics modeling team and broader PBPK consultancy group
• Lead and contribute to cross-Certara modeling and other initiatives

Qualifications

• A PhD degree in a relevant field or equivalent experience in biopharmaceutics/formulation/IVIVE/drug metabolism/pharmacokinetics
• 8+ years of experience in the field of PBPK/PBBM modelling with demonstrable experience in biopharmaceutic applications
• In-depth knowledge of the application of PBPK modelling in the drug discovery and development process and awareness of its acceptance across various regulatory bodies
• Demonstrable practical experience with the leading PBPK/PBBM modeling platforms, ideally including Simcyp®.
• Ability and desire to supervise a team of scientists and/or consultants within the PBPK consulting team.
• Excellent oral and written communication skills to effectively engage with peers and clients within industry, academia and regulatory agencies
• Peer-respected standing in the industry to grow a client base and expand the PBPK consultancy group globally

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.