Senior Scientist, Quantitative Modeling & PK

CSL Plasma Inc.; Zürich; Vor Ort; CHF 130.000 - 190.000; Vollzeit

Zusammenfassung

CSL Plasma Inc. seeks a Senior Scientist for Quantitative Modeling & PK to support non-clinical drug development from candidate selection to first-in-human dose prediction.

The role blends PK/PD modeling with mechanistic approaches, requiring collaboration with PK scientists and cross-functional project teams. You will design and apply exposure-response, PBPK, QSP, and other quantitative methods, analyze PK/TK data, and prepare data for regulatory submissions while effectively communicating

Qualifikationen

• Ph.D., M.Sc., or equivalent degree in Pharmacometrics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Applied Mathematics, Systems Biology, or a related discipline.
• Minimum 3 years of modeling and simulation experience in non-clinical drug development within pharma, biotech, or CRO.
• Experience with PK/PD, PBPK, QSP or other mechanistic modeling approaches.
• Proficiency with modeling tools Monolix, Simulx, NONMEM, R, MATLAB, Phoenix WinNonlin or similar.

Aufgaben

• Apply fit-for-purpose quantitative modeling to inform candidate selection, study design, and first-in-human dose prediction.
• Develop and apply PK/PD, PBPK, QSP, and mechanistic models for non-clinical programs.
• Design, analyze, and interpret non-clinical PK/PD studies to maximize decision value.
• Perform non-compartmental analysis (NCA) of PK/TK data and generate regulatory-ready reports.
• Clearly communicate quantitative insights to technical and non-technical audiences.
• Contribute to regulatory submission documents with quantitative analyses and justifications.
• Collaborate with cross-functional teams including pharmacology, toxicology, translational, and clinical pharmacology.

Kenntnisse

PK/PD modeling

Quantitative modeling

Exposur e-response analysis

Ausbildung

PhD or MSc in relevant field

Tools

Monolix

Simulx

NONMEM

R

MATLAB

Phoenix WinNonlin

Jobbeschreibung

The Senior Scientist, Quantitative Modeling & PK supports non-clinical drug development from candidate selection through first-in-human dose prediction by applying fit-for-purpose quantitative modeling approaches to inform key development decisions. Embedded within the Non-Clinical PK & Modeling group, the role combines quantitative modeling with a strong understanding of pharmacokinetics, pharmacology, and non-clinical development. The successful candidate will work closely with PK scientists and cross-functional project teams to design informative studies, integrate diverse datasets, develop predictive models, and translate quantitative insights into actionable development recommendations. **Main Responsibilities** * Apply fit-for-purpose quantitative modeling approaches to address key non-clinical development questions, including candidate selection, study design, and first-in-human dose prediction.* Develop and apply a range of modeling methodologies, including exposure-response, PK-target binding, empirical and mechanistic PK/PD, PBPK, systems biology, and QSP models.* Contribute to the design, analysis, and interpretation of non-clinical PK, PK/PD, and mechanistic studies to maximize decision-making value and reduce development risk.* Perform non-compartmental analysis (NCA) of PK and TK data and prepare corresponding reports to support regulatory submissions.* Communicate quantitative insights and recommendations clearly to both technical and non-technical audiences.* Contribute to the preparation and review of regulatory submission documents, including quantitative analyses and scientific justifications.* Collaborate closely with cross-functional project teams, in particular with non-clinical pharmacology, toxicology, translational research, and clinical pharmacology. **Qualifications and Experience Requirements** * Ph.D., M.Sc., or equivalent degree in Pharmacometrics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, Applied Mathematics, Systems Biology, or a related discipline.* Minimum 3 years of experience applying modeling and simulation approaches to support non-clinical drug development in a pharmaceutical, biotechnology, or CRO environment.* Strong quantitative modeling skills, with experience in PK/PD, PBPK, QSP, and/or other mechanistic modeling approaches.* Good understanding of PK, pharmacology, and non-clinical drug development, including experience supporting the design, analysis, and interpretation of preclinical PK and/or PK/PD studies.* Experience using industry-standard modeling and data analysis tools such as Monolix, Simulx, NONMEM, R, MATLAB, Phoenix WinNonlin, or similar platforms.* Strong communication and collaboration skills, with the ability to work effectively in cross-functional teams.* Scientific curiosity and integrity, sound judgment, and the ability to work independently in a fast-paced development environment.* Experience with multiple drug modalities and/or therapeutic areas is desirable. We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and diplomas.