Vice President, PBPK
Overview:
About CertaraCertara 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 LeadershipDefine and execute the company’s PBPK strategy aligned with R&D, regulatory, and corporate objectivesDrive integration of PBPK modeling into decision-making across discovery, translational science, clinical development, and lifecycle managementServe as a core member of senior leadership, influencing portfolio strategy and development prioritizationScientific & Technical OversightProvide expert oversight of PBPK model development, qualification, validation, and applicationEnsure best-in-class scientific rigor, innovation, and adoption of emerging methodologies and platformsGuide PBPK applications including first-in-human dose selection, DDIs, special populations, pediatrics, formulation changes, and label claimsRegulatory & External EngagementLead PBPK strategy for global regulatory interactions (FDA, EMA, PMDA, etc.)Act as a primary scientific representative in regulatory meetings, advisory boards, and industry consortiaContribute to regulatory submissions, briefing documents, and responses related to PBPK and MIDDOrganizational LeadershipBuild, mentor, and lead a high-performing PBPK and modeling organizationFoster a culture of collaboration, scientific excellence, and continuous developmentPartner cross-functionally with clinical pharmacology, biostatistics, toxicology, chemistry, clinical, regulatory, and commercial teamsThought Leadership & InnovationMaintain external visibility through publications, presentations, and professional societiesEvaluate and implement new modeling technologies, platforms, and data sourcesShape industry standards and best practices in PBPK and model-informed drug development
Qualifications:
EducationPhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Applied Mathematics, or a related fieldExperience12+ years of progressive experience in PBPK modeling within pharma, biotech, CRO, or regulatory agenciesDemonstrated leadership of PBPK or MIDD groups at a senior or executive levelProven track record of successful regulatory impact using PBPK approachesExperience influencing portfolio and development strategy at the enterprise levelSkills & CompetenciesDeep technical expertise in PBPK theory, software platforms, and applicationsStrong regulatory knowledge and experience with global health authoritiesExceptional leadership, communication, and stakeholder-management skillsStrategic thinker with the ability to translate complex science into business valuePreferred AttributesRecognized 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.
Apply Now
About CertaraCertara 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 LeadershipDefine and execute the company’s PBPK strategy aligned with R&D, regulatory, and corporate objectivesDrive integration of PBPK modeling into decision-making across discovery, translational science, clinical development, and lifecycle managementServe as a core member of senior leadership, influencing portfolio strategy and development prioritizationScientific & Technical OversightProvide expert oversight of PBPK model development, qualification, validation, and applicationEnsure best-in-class scientific rigor, innovation, and adoption of emerging methodologies and platformsGuide PBPK applications including first-in-human dose selection, DDIs, special populations, pediatrics, formulation changes, and label claimsRegulatory & External EngagementLead PBPK strategy for global regulatory interactions (FDA, EMA, PMDA, etc.)Act as a primary scientific representative in regulatory meetings, advisory boards, and industry consortiaContribute to regulatory submissions, briefing documents, and responses related to PBPK and MIDDOrganizational LeadershipBuild, mentor, and lead a high-performing PBPK and modeling organizationFoster a culture of collaboration, scientific excellence, and continuous developmentPartner cross-functionally with clinical pharmacology, biostatistics, toxicology, chemistry, clinical, regulatory, and commercial teamsThought Leadership & InnovationMaintain external visibility through publications, presentations, and professional societiesEvaluate and implement new modeling technologies, platforms, and data sourcesShape industry standards and best practices in PBPK and model-informed drug development
Qualifications:
EducationPhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Chemical Engineering, Applied Mathematics, or a related fieldExperience12+ years of progressive experience in PBPK modeling within pharma, biotech, CRO, or regulatory agenciesDemonstrated leadership of PBPK or MIDD groups at a senior or executive levelProven track record of successful regulatory impact using PBPK approachesExperience influencing portfolio and development strategy at the enterprise levelSkills & CompetenciesDeep technical expertise in PBPK theory, software platforms, and applicationsStrong regulatory knowledge and experience with global health authoritiesExceptional leadership, communication, and stakeholder-management skillsStrategic thinker with the ability to translate complex science into business valuePreferred AttributesRecognized 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.
Apply Now