The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects, serving as the primary PK/QSP representative on interdisciplinary project teams
Job Summary
The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects, serving as the primary PK/QSP representative on interdisciplinary project teams.
This role is responsible for the design, budgeting, and monitoring of non-clinical PK/QSP studies, both internally and externally, and performing advanced PK/PD modeling to define dose-concentration-efficacy/toxicity relationships.
CSL Behring is a global biotherapeutics leader focused on serving patients' needs by discovering, developing, and delivering innovative therapies for conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
Matching Summary
The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects, serving as the primary PK/QSP representative on interdisciplinary project teams.
Skills & Requirements
Must-have
Nonclinical PK/QSP strategies
PK/QSP representative on project teams
PK/PD modeling
GLP and non-GLP studies
ICH guidelines
Regulatory submissions
Nice-to-have
Cross-functional collaboration
External collaborations with academic groups
Multicultural and international teams
Experience with CSL’s disease therapeutic areas
Experience across multiple therapeutic areas and modalities
Key Requirements
PhD in Pharmaceutical Sciences or related subject area
Minimum 5+ years pharmaceutical development experience
Focus on modeling and simulation
Training in PK/PD, modeling and simulation
Industry standard software packages (Phoenix WinNonlin, NONMEM, R)
Proven track record in nonclinical PK/QSP assessments
Strong understanding of GLP regulations
Excellent communication, leadership, and cross-functional collaboration skills