layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Director, QSP/ PBPK Modeling at Kiniksa Pharmaceuticals | LAYIQ

(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.

Senior Director, QSP/ PBPK Modeling

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Equal opportunity and accommodations

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