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.
The Vice President of PBPK provides strategic, scientific, and organizational leadership for all physiologically based pharmacokinetic (PBPK) modeling and simulation activities across the company. This role is responsible for setting the vision for PBPK integration across discovery, preclinical, and clinical development, ensuring scientific excellence, regulatory impact, and business value. The SVP PBPK serves as a key scientific authority, internal advisor, and external thought leader in model-informed drug development (MIDD).
Responsibilities:
Strategic Leadership
- Define and execute the company’s PBPK strategy aligned with R&D, regulatory, and corporate objectives
- Drive integration of PBPK modeling into decision-making across discovery, translational science, clinical development, and lifecycle management
- Serve as a core member of senior leadership, influencing portfolio strategy and development prioritization
Scientific & Technical Oversight
- Provide expert oversight of PBPK model development, qualification, validation, and application
- Ensure best-in-class scientific rigor, innovation, and adoption of emerging methodologies and platforms
- Guide PBPK applications including first-in-human dose selection, DDIs, special populations, pediatrics, formulation changes, and label claims
Regulatory & External Engagement
- Lead PBPK strategy for global regulatory interactions (FDA, EMA, PMDA, etc.)
- Act as a primary scientific representative in regulatory meetings, advisory boards, and industry consortia
- Contribute to regulatory submissions, briefing documents, and responses related to PBPK and MIDD
Organizational Leadership
- Build, mentor, and lead a high-performing PBPK and modeling organization
- Foster a culture of collaboration, scientific excellence, and continuous development
- Partner cross-functionally with clinical pharmacology, biostatistics, toxicology, chemistry, clinical, regulatory, and commercial teams
Thought Leadership & Innovation
- Maintain external visibility through publications, presentations, and professional societies
- Evaluate and implement new modeling technologies, platforms, and data sources
- Shape industry standards and best practices in PBPK and model-informed drug development
Qualifications:
Education
- PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Applied Mathematics, or a related field
Experience
- 12+ years of progressive experience in PBPK modeling within pharma, biotech, CRO, or regulatory agencies
- Demonstrated leadership of PBPK or MIDD groups at a senior or executive level
- Proven track record of successful regulatory impact using PBPK approaches
- Experience influencing portfolio and development strategy at the enterprise level
Skills & Competencies
- Deep technical expertise in PBPK theory, software platforms, and applications
- Strong regulatory knowledge and experience with global health authorities
- Exceptional leadership, communication, and stakeholder-management skills
- Strategic thinker with the ability to translate complex science into business value
Preferred Attributes
- Recognized external expert or opinion leader in PBPK or MIDD
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.
