Posted on Apr 16, 2021 by Roche
The Preclinical and Translational PKPD (PTPK) Department is seeking a lab-based scientist to drive the understanding of the fate, disposition (ADME) and pharmacokinetics of novel biotherapeutic candidates and delivery systems. The core responsibilities include development and execution of preclinical strategies to understand the basic pharmacology, ADME and PKPD of novel therapeutics in preclinical models to guide design, delivery, and development of novel therapeutics in the Genentech pipeline, and for translating preclinical PKPD to ensure appropriate dose/regimen decisions using state-of-the art experimental and quantitative approaches. The candidate will work in a highly collaborative, cross-functional environment, with partnerships across Research, Drug Delivery, Development Sciences, Clinical Sciences, Biostatistics, and Regulatory, to represent PTPK at cross-functional teams, department meetings, review committees, and conferences.
Who You Are:
We are looking for individuals who are inspired by our mission and who would fit in well with the collaborative, rigorous, and entrepreneurial spirit of company culture. A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Biomedical Engineering, or related discipline. Minimum of 0+ years (for Associate Scientist), 3+ years (for Scientist), and 7+ years (for Senior Scientist) of relevant PKPD experience and demonstrated impact on drug development and/or the PKPD scientific landscape.
Ph.D. degree or equivalent curriculum (such as PharmD, M.D.) in pharmacology, pharmaceutical science, cellular and molecular biology, bioengineering or related disciplines is required.
Post-doctoral experience may not be required dependent on the specific job level. Minimum of 0+ years (for Associate Scientist), 3+ years (for Scientist), and 7+ years (for Senior Scientist) experience in the field of drug discovery or drug development or relevant area of expertise.
Strong knowledge and experience in pharmacology, molecule/cell biology, oncology and immunology are highly desirable.
Strong knowledge and experience in PKPD of biologics (protein, and/or gene, ASO, RNA therapeutics) are highly desirable.
Strong laboratory techniques/skills including cell culture, molecule labeling, molecular and cellular analysis, HPLC, animal studies, sample preparation, Immunoprecipitation, Western blot, and Lab safety are required
Outstanding record of accomplishment in his/her field as evidenced by his/her co-authored publications, patents, internal reports and/or regulatory filings. Must demonstrate significant scientific ability or drug development experience.
Working knowledge of PKPD software and the ability to analyze and critically assess PKPD data is desirable.
Demonstrates ingenuity, creativity, and resourcefulness in design of studies and experiments; applies advanced principles, theories and concepts to drug development; independently designs, carries out, analyzes, interprets, and documents studies and experiments or provides guidance to research associates and junior scientists.
Good communication skills including both oral and writing, independently presents at department and project team meeting and may be invited to present at review committees and regulatory meetings.
The candidate should have experience working on cross-functional teams, demonstrate excellent communication skills, and have the ability to work independently and effectively.
Design, conduct, analyze and interpret all in vitro and in vivo ADME and PKPD studies that are necessary to understand the pharmacology of drug candidates in animals and predict their behavior in humans
Prepare documents and reports for internal governance committees and regulatory agencies, including INDs and BLAs
Publish innovative PKPD focused research in high quality scientific, technical or medical journals, present to key subject matter experts and at meetings and promote collaborative efforts to push PKPD sciences forward.
Manage an active laboratory program that supports basic research in PKPD and also supports pipeline projects, and regulatory filings
Collaborate with other departments such as Clinical Pharmacology, Research, Bioanalytical Sciences, Safety Assessment, PD Biomarker/OMNI, Antibody Engineering, Non-clinical Biostatistics, Regulatory Affairs, Technical Development, and others
Provide scientific leadership within PTPK and other functions as well as on cross-functional teams; be an established thought leader within their field of expertise (Senior Scientist)
Lead research or development programs, including cross-functional teams, or teams focusing on new technologies (for Senior Scientist)
Participate in compliance and safety related activities
Perform other duties, as assigned
Be an externally, recognized scientific leader in basic research in PKPD and in drug development (for Senior Scientist)
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