CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Position Description Summary:
The Associate Director PK/QSP is responsible for leading the design, execution, and interpretation of pharmacokinetic (PK), toxicokinetic (TK), strategies to support drug discovery, nonclinical and development programs across multiple therapeutic areas. The Sr. Expert will lead a team of Principle and Senior PK Scientists to ensure effective and consistent approaches for IND-enabling PK strategies and studies.
Main Responsibilities:
Strategic Leadership
Lead the design and execution of pharmacokinetic (PK) and toxicokinetic (TK) strategies.
Provide scientific leadership across drug discovery, nonclinical, and development programs.
Ensure alignment of PK/TK strategies with overall program goals across multiple therapeutic areas.
Team Management
Supervise and mentor a team of Principal and Senior PK Scientists.
Foster a collaborative and high-performance team environment.
Guide team members in developing and implementing IND-enabling PK strategies.
Study Oversight and Execution
Oversee the planning, execution, and interpretation of PK/TK studies.
Ensure scientific rigor and regulatory compliance in studies conducted at external CROs
Troubleshoot and resolve issues related to study design, data interpretation, and timelines.
Cross-Functional Collaboration
Collaborate with Research, NCD and relevant development functions and CMC
Contribute to regulatory submissions (e.g., INDs, NDAs) by providing PK/TK data and interpretation.
Represent PK/QSP function in project teams and governance meetings.
Qualifications and Experience Requirements:
Ph.D. in a Life Sciences discipline such as Pharmacokinetics, Systems Pharmacology, Pharmacometrics, Biomedical Engineering, or a related field.
8+ years of industry experience in PK/PD, PBPK.
Proficiency in relevant software for PK/PD, PBPK.
Strong understanding of ADME, pharmacology, and translational science.
Excellent leadership, and project management skills.
Experience with omics data integration, machine learning, or AI-enhanced modeling is a plus.
Ability to manage multiple projects and timelines.
Experience across multiple therapeutic areas and modalities is highly desirable.
Excellent communication and stakeholder engagement skills, with the ability to influence at all levels of the organization.
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/.
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.
