Director of Clinical Pharmacology & Pharmacometrics
Greater Bay Area
Currently working with a leading Clinical-Stage Biotech focused on developing and delivering next-generation oncology related therapeutics.
They are looking add a Director of Clinical Pharmacology & Pharmacometrics who will cover Clinical Pharmacology, Modeling & Simulation, for their early and late stage programs!
Duties and Responsibilities:
- Lead the Clinical Pharmacology Portfolio with strategic input on the early and late stage oncology-focused programs
- Hands on approach within modeling & simulation, integrating PK, PD, safety, and efficacy data
- Represent the Clinical Pharmacology Department during Internal and External meeting related to clinical PK, PK/PD, PopPK and Clinical Pharmacology
- CRO selection and Management
- M.S or Ph.D. in Pharmacology or a related scientific field with ideally 5-7 years of industry experience(Ph.D - highly coveted)
- Experience leading outsourced vendors(CROs)
- Hands on experience with M&S tools -Nonmem, PK-Sim, Phoenix WinNolin, MATLAB, SimBiology, Etc.
- leadership and project management skills
- Expert in NDA, and BLA regulatory filings