South San Francisco, California
The Clinical Pharmacology Department at Genentech, Inc. is seeking Ph.D. level Associate Scientist, Scientist, or Senior Scientist who is driven to use cutting edge modeling approaches to advance the clinical development of novel drug candidates to join our diverse group of pharmacometricians, system modelers, advanced programmers, and artificial intelligence/machine learning scientists. 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.
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 advanced statistical modeling, clinical trial simulation, optimal design, advanced mechanistic PK/PD modeling is highly preferred. Experience in interaction with regulatory agencies is 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.
A Ph.D. or equivalent in Pharmacometrics, Biostatistics, Biomedical or Chemical Engineering, Applied Mathematics or Physics, Pharmaceutical Sciences, or related discipline with 0+ year (for Associate Scientist), 3+ years (for Scientist), 7+ years (for Senior Scientist) of industry, regulatory, and/or related post-doctoral Modeling and Simulation experience is required.
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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