Job Type : Full time
Role overview :
As Pharmacometrics / PBPK Lead, you will be responsible for leading the development and application of physiologically based pharmacokinetic (PBPK) models to support biologics programs across discovery, preclinical, and clinical stages. You’ll work cross-functionally with DMPK, clinical pharmacology, regulatory, and translational sciences teams to influence strategic decisions and optimize drug development.
Key Responsibilities
* Lead PBPK modeling strategies for monoclonal antibodies, ADCs, fusion proteins, and other biologics.
* Develop and validate mechanistic models to support dose selection, trial design, and regulatory submissions.
* Partner with discovery and development teams to influence candidate selection and first-in-human dosing strategies.
* Interpret and communicate model outcomes to cross-functional stakeholders and senior leadership.
* Represent PBPK strategy in regulatory interactions and author relevant sections of INDs, CTAs, and BLAs.
* Mentor junior scientists and contribute to best practices in model-informed drug development (MIDD).
Qualifications
* PhD in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, or related field.
* 5+ years of industry experience in PBPK modeling, with a strong focus on biologics.
* Proficiency in software such as Simcyp, PK-Sim, GastroPlus, MATLAB, or similar tools.
* Deep understanding of ADME and pharmacokinetics of large molecules.
* Experience contributing to regulatory filings and interacting with health authorities.
* Strong communication and presentation skills.
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