Senior Director, QSP/ PBPK Modeling
Kiniksa Pharmaceuticals
4 hours ago
On-site
Lexington, MA
Clinical Research and Development
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
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