South San Francisco
California, United States of America
The Clinical Pharmacology Scientist is responsible for the Clinical Pharmacology (CP) strategy for his/her development project[s] in order to ensure that appropriate dose/route/schedule decisions are made for the patients. The CP Scientist uses state of the art model-informed drug development strategies that are aligned with project needs. The CP Scientist works in close partnership with Pharmacometricians, Biostatisticians, Clinicians and cross-functional project teams. Responsibilities include; leading the design & review of CP study protocols and analysis plans where appropriate, contributing to the design and review of clinical protocols and analysis plans, analysis and interpretation of PK/PD data, preparation and review of clinical study reports, presentation of PK/PD data at cross-functional teams, department meetings, conferences and regulatory meetings as well as planning, implementation and organization of regulatory filings (eg. IND, End-of Phase 2 meeting, EU Scientific Advice meeting, BLA, NDA, sNDA).
Drug Development Knowledge:
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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