QSP Modeling Lead, Oncology R&D, Orion Corporation

The QSP Modeling Lead will generate and implement mechanistic pharmacology models to support drug development at all stages, from preclinical research to clinical trials and beyond, enabling dose optimization, biomarker identification, safety and efficacy assessment, and drug development decision‑making through integrated non‑clinical and clinical data. This position reports to the VP Global Translational Medicine and is based in Cambridge, MA, US (hybrid per Orion policy). Key Responsibilities Lead the design, development, validation, and application of QSP models that will inform compound progression decisions from lead optimization to clinical proof of concept and beyond for the oncology pipelines for all modalities of interest. Integrate non‑clinical PK/PD, efficacy, and biomarker data with emerging clinical PK/PD and biomarker data to inform human dose optimization, biomarker identification, safety and efficacy assessment, and drug development decision‑making. Drive model‑informed drug development (MIDD) strategies across programs, influencing key development and portfolio decisions. Partner closely with Clinical Pharmacology and Translational Medicine Lead to ensure alignment between pharmacology modeling, bioanalytical strategies, and clinical endpoints. Communicate clearly and timely with project team members from diverse backgrounds, explaining and educating model‑based analyses and results. Collaborate with dynamic teams and associated functions, and lead the development and implementation of innovative modeling and simulation platforms/strategies that ensure the right drug is administered to the right patient at the right dosage. Contribute to the preparation and presentation of internal and external documentation (e.g., Investigator’s Brochure, IND, CTD) and program strategy. Qualifications Basic Qualifications: PhD in Pharmacology, Biomedical/Chemical Engineering, Biology, Systems Biology, Applied Mathematics, or a related quantitative discipline. Industry‑relevant experience in QSP modeling and application of MIDD principles in a drug‑development setting. Extensive experience with exploratory data analysis, modeling, and simulation using Python or R. Preferred Qualifications: Excellent knowledge of the theory and principles of Quantitative Systems Pharmacology and hands‑on competence in mathematical modeling of pharmacologic effects with mechanism‑based models using relevant software or programming languages (e.g., MATLAB/SimBiology, Monolix, R). Solid knowledge of basic principles of biology and pharmacology at the organismal, cellular, and molecular level, preferably in oncology. Ability to assimilate complex biology of drug action for novel mechanisms and translate that understanding into multi‑scale mathematical models, with requisite mathematical and computational proficiency. Ability to work independently and deliver results in a timely manner. #J-18808-Ljbffr Orion Pharma