Senior Scientist, Quantitative Modeling & PK

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.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

• 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.