Position Description Summary:
The PK/QSP Lead is responsible for leading the design, execution, and interpretation of pharmacokinetic (PK), toxicokinetic (TK), physiologically-based pharmacokinetic (PBPK), and quantitative systems pharmacology (QSP) modeling strategies to support drug discovery, nonclinical and development programs across multiple therapeutic areas.
Main Responsibilities:
Strategic Leadership & Scientific Expertise
Lead the development and execution of integrated PK, PBPK, and QSP modeling strategies across multiple therapeutic programs.
Serve as the subject matter expert (SME) in modeling and simulation, advising project teams on optimal study design, dose selection, and risk assessment.
Champion model-informed drug development (MIDD) approaches to enhance translational understanding and regulatory confidence.
PK and Model Development
Lead the design and execution of nonclinical PK and TK studies to support research and IND-enabling packages.
Lead the design and execution of PBPK and QSP modeling strategies across multiple programs.
Cross-Functional Collaboration
Act as Sr. PK/QSP lead on TA teams.
Collaborate closely with Research, Nonclinical development functions, Clinical Development and Clinical Pharmacometrics to ensure alignment of Pharmacokinetic and modeling strategies with program goals.
Participate in cross-functional project teams, providing scientific input and modeling insights to guide key development decisions.
Provide expert input into due diligence for in-licensing or partnership opportunities.
Regulatory & Documentation
Contribute to and review Nonclinical Pharmacokinetic sections for submission documents.
Prepare and review modeling reports and regulatory documents.
Innovation & Continuous Learning
Stay abreast of emerging trends, technologies, and regulatory expectations in PK, PBPK, and QSP modeling.
Contribute to scientific publications, conference presentations, and internal knowledge-sharing initiatives.
Team Leadership:
Lead and mentor a team of Principal and Sr. scientists.
Foster a culture of scientific excellence, innovation, and continuous learning.
Qualifications and Experience Requirements:
Ph.D. in Pharmacokinetics, Systems Pharmacology, Pharmacometrics, Biomedical Engineering, or a related field.
10+ years of pharmaceutical industry experience in PK/PD, PBPK, and/or QSP modeling.
Proven track record of applying modeling to support drug development and regulatory submissions.
Proficiency in modeling software for PK/PD, PBPK, QSP
Strong understanding of ADME, pharmacology, and translational science.
Excellent communication, 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.
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
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.
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. Learn more Inclusion and Belonging | CSL.