Senior Director, QSP/PBPK Modeling

Responsibilities

• Lead the design, development, validation, and application of pharmacology models, including empirical and mechanistic models (PBPK, QSP, systems PK/PD)
• Integrate non-clinical PK/PD, efficacy, and biomarker data with emerging clinical data to inform human PK predictions and dose selection
• Provide quantitative support for first-in-human (FIH), dose escalation, and proof-of-concept studies
• Drive model-informed drug development (MIDD) strategies across programs
• Partner with Clinical Pharmacology and Translational Medicine to ensure alignment between modeling and clinical endpoints
• Author and review modeling sections for INDs, IBs, clinical study reports, and regulatory briefing documents
• Evaluate and implement new modeling methodologies and platforms

Requirements

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, or a related quantitative discipline
• 10+ years of relevant experience in quantitative pharmacology, pharmacometrics, or systems pharmacology within biotech or pharmaceutical R&D
• Demonstrated progression to scientific leadership roles
• Deep expertise in nonlinear mixed-effects modeling and mechanistic PK/PD modeling
• Proficiency with modeling software such as Matlab, SimBiology, OSP Suite, Simcyp, Gastroplus, Monolix, or R
• Strong understanding of drug development, clinical trial design, and regulatory expectations

About the Company

Kiniksa Pharmaceuticals is a commercial-stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications.