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
1. Lead the design and execution of pharmacokinetic (PK) and toxicokinetic (TK) strategies.
2. Provide scientific leadership across drug discovery, nonclinical, and development programs.
3. Ensure alignment of PK/TK strategies with overall program goals across multiple therapeutic areas.
Team Management
4. Supervise and mentor a team of Principal and Senior PK Scientists.
5. Foster a collaborative and high-performance team environment.
6. Guide team members in developing and implementing IND-enabling PK strategies.
Study Oversight and Execution
7. Oversee the planning, execution, and interpretation of PK/TK studies.
8. Ensure scientific rigor and regulatory compliance in studies conducted at external CROs
9. Troubleshoot and resolve issues related to study design, data interpretation, and timelines.
Cross-Functional Collaboration
10. Collaborate with Research, NCD and relevant development functions and CMC
11. Contribute to regulatory submissions (e.g., INDs, NDAs) by providing PK/TK data and interpretation.
12. Represent PK/QSP function in project teams and governance meetings.
Qualifications and Experience Requirements:
13. Ph.D. in a Life Sciences discipline such as Pharmacokinetics, Systems Pharmacology, Pharmacometrics, Biomedical Engineering, or a related field.
14. 8+ years of industry experience in PK/PD, PBPK.
15. Proficiency in relevant software for PK/PD, PBPK.
16. Strong understanding of ADME, pharmacology, and translational science.
17. Excellent leadership, and project management skills.
18. Experience with omics data integration, machine learning, or AI-enhanced modeling is a plus.
19. Ability to manage multiple projects and timelines.
20. Experience across multiple therapeutic areas and modalities is highly desirable.
21. 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 and CSL Plasma at .
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