South San Francisco
California, United States of America
RESPONSIBILITIES: The Clinical Pharmacology Department at Genentech, Inc. is seeking Ph.D. level Senior Scientist or Principal Scientist who is driven to use pharmacometrics to advance the clinical development of novel drug candidates. This individual will be responsible for the development and implementation of Modeling and Simulation (M&S) strategy, in order to ensure that the right drug is administered to the right patient at the right dosing regimen. The modeling and simulation activities include population PK/PD models, disease models, statistical models, physiologically-based PK (PBPK) models, quantitative system pharmacology (QSP) models, clinical trial simulations, literature meta-analysis, machine learning/deep learning, and other state of the art quantitative techniques. Key technical responsibilities are to organize, execute, and report M&S independently, as well as to present work at cross-functional teams, department meetings, senior management review committees, regulatory interactions, and scientific conferences. Other responsibilities will include planning, writing, and reviewing relevant clinical documents such as study protocols, analysis plans, reports, and regulatory documents. These will be accomplished by working in close partnership with other scientists in Clinical Pharmacology, Clinical Science, Biostatistics, Preclinical and Translational PK, DMPK, Safety Assessment, Biomarker, Diagnostics, Regulatory, RWD (Real World Data), and other functions on project teams. Qualified candidate could be responsible to manage employees via direct and/or matrix management system, providing oversight of the strategy and implementation of M&S by other scientists across projects.
REQUIREMENTS: Candidates should have solid expertise in quantitative pharmacology and strong hands-on modeling and simulation skills. Rich hands-on experience with NONMEM, R, SimBiology, Simcyp, GastroPlus, , and/or other modeling and simulation software is required. Experience with clinical trial simulation, optimal design, advanced mechanistic PK/PD modeling is highly preferred. Experience in interaction with regulatory agencies is highly desired. The candidate must have excellent communication and interpersonal skills and the ability to work independently and effectively on interdepartmental project teams. For experienced candidate, he/she should have demonstrated impact on drug development through quantitative approaches. The candidate must have strong leadership skills and the ability to influence. People management experiences are a plus.
EDUCATION: A Ph.D. or equivalent in Pharmacometrics, Biostatistics, Biomedical or Chemical Engineering, Applied Mathematics or Physics, Pharmaceutical Sciences, or related discipline with 7+ years (for Senior Scientist), 13+ years (for Principal Scientist) of industry, regulatory, and/or related post-doctoral Modeling and Simulation experience is required.
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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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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