Senior Director, QSP/PBPK Modeling Leader

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 281,000 - 299,000; Full time

Job summary

Kiniksa Pharmaceuticals seeks a Senior Director of QSP/PBPK Modeling to lead the design, validation, and application of quantitative pharmacology models. You will integrate diverse data streams to predict human PK, inform dose selection, and shape clinical trial design.

The role requires a PhD and 10+ years in pharmacometrics with leadership experience, plus expert use of Matlab/SimBiology, OSP Suite, Simcyp, GastroPlus, Monolix, and R. Onsite in Lexington, MA with full-time commitment.

Qualifications

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, or related quantitative field.
• 10+ years in quantitative pharmacology, pharmacometrics, or systems pharmacology (biotech/pharma R&D) with progression to scientific leadership.
• Deep hands-on expertise in nonlinear mixed-effects modeling and mechanistic PK/PD modeling (PBPK, TMDD, systems pharmacology).
• Translate non-clinical PK/PD to human dose prediction for clinical decision-making.
• Ability to clearly communicate complex quantitative concepts to multidisciplinary audiences.

Responsibilities

• Lead the design, development, validation, and application of pharmacology models including empirical and mechanistic approaches.
• Integrate non-clinical and emerging clinical PK/PD data to support human PK predictions and dose selection.
• Provide quantitative support for FIH, dose escalation, and proof-of-concept studies.
• Drive MIDD strategies across programs to influence development decisions.
• Partner with Clinical Pharmacology to align modeling with clinical endpoints and regulatory expectations.
• Author modeling sections for INDs, IBs, and regulatory submissions; support regulatory interactions as SME.
• Ensure rigor, documentation quality, and regulatory readiness of modeling deliverables.
• Evaluate new modeling methodologies, platforms, and best practices.

Skills

Nonlinear mixed-effects modeling

Mechanistic PK/PD modeling

TMDD

Quantitative pharmacology

Model-informed drug development

Education

Ph.D. in Pharmacology

Tools

Matlab/SimBiology

OSP Suite

Simcyp

GastroPlus

Monolix

R

Job description

Kiniksa Pharmaceuticals seeks a Senior Director of QSP/PBPK Modeling to lead the design, validation, and application of quantitative pharmacology models. You will integrate diverse data streams to predict human PK, inform dose selection, and shape clinical trial design.

The role requires a PhD and 10+ years in pharmacometrics with leadership experience, plus expert use of Matlab/SimBiology, OSP Suite, Simcyp, GastroPlus, Monolix, and R. Onsite in Lexington, MA with full-time commitment.