The Principal Scientist PK/QSP will lead and manage nonclinical PK/QSP strategies across multiple drug development projects. This role serves as the primary PK/QSP representative on interdisciplinary project teams and provides scientific leadership from early discovery through regulatory submission and market authorization.
Requirements
- PhD in Pharmaceutical Sciences or related subject area with minimum 5+ years of pharmaceutical development experience in pharma, biotech, or CRO, with a focus on modeling and simulation.
- Training in PK/PD, modelling and simulation, using industry standard software packages, such as Phoenix WinNonLin, NONMEM, R, etc.
- Proven track record in nonclinical PK/QSP assessments and regulatory submissions.
- Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Experience with CSL’s disease therapeutic areas.
- Experience across multiple therapeutic areas and modalities is highly desirable.
- Experience working in multicultural and international teams.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship