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.
Senior Scientist, Quantitative Modeling & PK in Höfen Arbeitgeber: CSL
Unser Unternehmen bietet eine dynamische und unterstützende Arbeitsumgebung, die sich auf die Förderung von Innovation und Exzellenz in der analytischen Wissenschaft konzentriert. Mit einem starken Fokus auf Mitarbeiterentwicklung und kontinuierlichem Lernen bieten wir zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung, während wir gleichzeitig ein positives und kollaboratives Arbeitsklima pflegen. Unsere Lage in einer hochmodernen Einrichtung ermöglicht es Ihnen, an vorderster Front der pharmazeutischen Forschung zu arbeiten und einen bedeutenden Beitrag zur Verbesserung der Gesundheitsversorgung zu leisten.