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.
Responsibilities include the design, budgeting, and monitoring of non-clinical PK/QSP studies, performing advanced PK/PD modeling, and presenting integrated PK/QSP assessments to senior management.
CSL Behring is a global biotherapeutics leader focused on discovering, developing, and delivering innovative therapies for patients with serious conditions, driven by a promise to save lives.
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
Advanced PK/PD modeling
Study design and protocol development
GLP regulations and ICH guidelines
Nice-to-have
Cross-functional project leadership
External collaboration and CRO selection
Mentorship of junior team members
Experience with CSL's therapeutic areas
Working in multicultural teams
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 software
Proven track record in nonclinical PK/QSP assessments and regulatory submissions