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.
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Skills Required
- Bachelor's, Master's, or Ph.D. in Life Sciences or related field with 3+ years pharmaceutical development experience in pharma, biotech, or CRO (modeling and simulation focus).
- Training and hands-on experience in PK/PD modeling and simulation.
- Proficiency with industry-standard software (Phoenix WinNonLin, NONMEM, R).
- Excellent communication and cross-functional collaboration skills.
- Experience with CSL therapeutic disease areas.
- Experience across multiple therapeutic areas and modalities.
What We Do
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
