Senior Vice President, PBPK

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

The Senior 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).

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

Education

• PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Applied Mathematics, or a related field

Experience

• 15+ 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.