Senior Director, QSP/ PBPK Modeling

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

Senior Director of QSP/PBPK Modeling

Key Responsibilities

• Lead the design, development, validation, and application of pharmacology models, including empirical (nonlinear mixed effects, exposure–response) and mechanistic models (PBPK, QSP, systems PK/PD).
• Integrate non-clinical PK/PD, efficacy, and biomarker data with emerging clinical PK/PD and biomarker data to support human PK predictions, dose selection, and clinical trial design.
• Provide quantitative support for first-in-human (FIH), dose escalation, and proof-of-concept studies.
• Drive model-informed drug development (MIDD) strategies across programs to influence development and portfolio decisions.
• Partner with Clinical Pharmacology and Translational Medicine to align pharmacology modeling, bioanalytical strategies, and clinical endpoints.
• Author/review modeling sections for INDs, IBs, clinical study reports, and regulatory briefing documents; support regulatory interactions as an SME.
• Ensure scientific rigor, documentation quality, and regulatory readiness of modeling deliverables.
• Evaluate and implement new modeling methodologies, platforms, and best practices.

Required Qualifications

• Ph.D. in Pharmacology, Pharmaceutics, Pharmaceutical Sciences, Biomedical Engineering, Applied Mathematics, 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), translating non‑clinical PK/PD to human dose prediction using tools such as Matlab/SimBiology, OSP Suite, Simcyp, Gastroplus, Monolix, and R.
• Strong understanding of drug development, clinical trial design, and regulatory expectations for pharmacology/pharmacometrics; experience using modeling for clinical decision‑making in early‑stage development.
• Ability to clearly communicate complex quantitative concepts to multidisciplinary, non-modeling audiences.

Pay Range

$281,000 - $299,000 USD

Work Location

Lexington, MA office; onsite five days per week