Kiniksapharmaceuticals

Senior Director, QSP/ PBPK Modeling

Lexington, MA · Director

Sponsorship not specified$281k-$299kDetected 21 days ago

MATLABPharmacologyFDA RegulatoryResearchLeadershipCommunicationProblem SolvingAdaptability

About the role

Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.
At Kiniksa, talented individuals are trusted and empowered to make a real impact-shaping the future of medicine while improving the lives of patients who need it most.
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.

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.
Evaluate and implement new modeling methodologies, platforms, and best practices consistent with industry and regulatory expectations.

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.

Ability to work in a highly collaborative environment
Strong sense of urgency and agility
This role is based in our Lexington, MA office and requires employees to be onsite five days per week

$281,000 - $299,000 USD
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.