Senior Director - QSP/PBPK Modeling

Kiniksa is seeking a highly experienced Senior Director of QSP/PBPK Modeling to lead the development and application of quantitative pharmacology models to support drug discovery and development programs. This role will be responsible for generating and implementing empirical and mechanistic pharmacology models to inform human pharmacokinetics (PK), pharmacodynamics (PD), dose selection, and overall clinical strategy, leveraging integrated non-clinical and clinical data.

The successful candidate will serve as a scientific and strategic leader, partnering cross‑functionally with Research, Translational Medicine, Clinical Pharmacology, Clinical Development, and Regulatory teams to ensure model‑informed decision making across the portfolio.

This is an excellent opportunity for candidates who work with a sense of urgency, enjoy distilling complexity into clarity, can effectively align inputs from different perspectives, and can think critically to synthesize information. Emphasis will be on prior drug development experience, good communication skills (verbal, written and non-verbal), problem-solving skills, and an adaptable growth mindset.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week

Responsibilities (including, but not limited to):

• 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 inform 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, influencing key development and portfolio decisions.
• Partner closely with Clinical Pharmacology and Translational Medicine to ensure alignment between pharmacology modeling, bioanalytical strategies, and clinical endpoints.
• Author and review modeling sections for INDs, IBs, clinical study reports, and regulatory briefing documents, and support regulatory interactions as a subject matter expert.
• Ensure scientific rigor, documentation quality, and regulatory readiness of all modeling deliverables.
• Evaluate and implement new modeling methodologies, platforms, and best practices consistent with industry and regulatory expectations.

Standout Skills for Impact:

• Deep hands‑on expertise in nonlinear mixed‑effects modeling (e.g., population PK/PD, exposure–response), mechanistic PK/PD modeling (e.g., PBPK, TMDD, systems pharmacology) and translation of non‑clinical PK/PD to human dose prediction using standard modeling software (e.g. Matlab / SimBiology, OSP Suite, Simcyp, Gastroplus, Monolix, R)
• Ability to work in a highly collaborative environment
• Strong sense of urgency and agility
• Strong understanding of drug development, clinical trial design, and regulatory expectations related to pharmacology and pharmacometrics, experience contributing regulatory interactions related to modeling and simulation and proven experience applying modeling approaches to clinical decision making, particularly for early‑stage development programs.

Qualifications and Experience:

• 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, with demonstrated progression to scientific leadership roles.
• Demonstrated ability to clearly communicate complex quantitative concepts to multidisciplinary, non‑modeling audiences.