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, focusing on 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 regulations
ICH guidelines
Global regulatory requirements
Nice-to-have
Cross-functional collaboration skills
External collaborations with academic groups
Experience across multiple therapeutic areas
Experience in multicultural and international teams
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, modeling and simulation
Industry standard software packages (Phoenix WinNonLin, NONMEM, R)
Proven track record in nonclinical PK/QSP assessments and regulatory submissions