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.
Tasks
- 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.
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.
Benefits
CSL offers benefits focused on well-being. Inclusion and belonging are core to the mission, fostering a diverse workforce and culture of curiosity and empathy. CSL is an Equal Opportunity Employer and provides reasonable accommodation for individuals with disabilities during the application process.
Bist du Teil dieses Unternehmens?
Dieses Unternehmensprofil wurde automatisch erstellt. Wenn du für CSL Behring arbeitest, kannst du das Profil jetzt beanspruchen und verifizieren – kostenlos und in wenigen Minuten.
Über uns
Das Team
The role is embedded within the Non-Clinical PK & Modeling group and involves close collaboration with PK scientists and cross-functional project teams, including non-clinical pharmacology, toxicology, translational research, and clinical pharmacology.