Additional Information
Position Description Summary:
The Scientist PK is responsible for monitoring of non-clinical PK/TK studies conducted internally and externally both in a GLP and non-GLP environment and support modelling activities.
Main Responsibilities:
Design, oversee, and interpret nonclinical PK/QSP studies (GLP and non-GLP) to support regulatory submissions and drug development.
Conduct PK, PBPK, QSP modelling and/or work with external collaborators.
Prepare and review regulatory nonclinical submission documents.
Collaborate with internal stakeholders including pharmacology, toxicology, clinical, regulatory, and CMC teams.
Qualifications and Experience Requirements:
Bachelor's, Master's, or Ph.D. in Life Sciences or related subject area with 3+ years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation.
Training in PK/PD, modelling and simulation, using industry standard software packages, such as Phoenix WinNonLin, NONMEM, R, etc.
Excellent communication, and cross-functional collaboration skills.
Experience with CSL's disease therapeutic areas.
Experience across multiple therapeutic areas and modalities is highly desirable.
May manage projects/processes, working independently with limited supervision
Coaches and reviews the work of lower-level professionals.
Problems faced are difficult and sometimes complex, often requiring understanding of broader set of issues.
Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity.
Works together with and provide expertise to other team members to achieve specified research project objectives within defined time parameters.
About CSL Behring
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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Csl · Emea, Ch, Glattbrugg, Csl Behring