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 conducted internally and externally in both GLP and non-GLP environments.
CSL Behring is a global biotherapeutics leader driven by its promise to save lives, focused on serving patients' needs by using the latest technologies to discover, develop and deliver innovative therapies.
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/ADME/QSP representative
PK Study Monitor
Advanced PK/PD modeling
GLP regulations, ICH guidelines
Cross-functional collaboration skills
Nice-to-have
Experience with CSL's disease therapeutic areas
Experience across multiple therapeutic areas
Working in multicultural and international teams
Quantitative Systems Pharmacology
Key Requirements
PhD in Pharmaceutical Sciences or related subject area
Minimum 5+ years of pharmaceutical development experience
Focus on modeling and simulation
Training in PK/PD, modelling and simulation
Proven track record in nonclinical PK/QSP assessments
Regulatory submissions experience
Strong understanding of global regulatory requirements