Senior Scientist, Quantitative Modeling & PK
CSL
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.
- 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.
- Responsibilities: * You will be responsible for scientific input to clinical development strategies and therapeutic areas. * Provide scientific and clinical development input for the safe and efficient execution of assigned programs, ensuring the highest quality and full...Empfohlen
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