The open position is to lead the preclinical pharmacokinetic and pharmacodynamics (PKPD) efforts to guide the design, delivery and development of biologics in the Genentech pipeline. Core responsibilities include development and execution of preclinical strategies to understand the basic pharmacology, ADME and PKPD of potential therapeutics, provide expertise and guidance on all aspects of PKPD on cross-functional teams, support regulatory filings and drive the science of PKPD both internally within Genentech and externally across academia, regulatory agencies, and industry consortia such as BIOSAFE and IQ.
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 findings
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
Lead research or development programs, including cross-functional teams, or teams focusing on new technologies
Participate in compliance and safety related activities
Perform other duties, as assigned
Ph.D. degree in pharmacology, pharmaceutical science, biology, bioengineering, chemistry, physiology or related disciplines is required.
3-5 years experience in the field of drug discovery or drug development or relevant area of expertise.
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.
Strong knowledge of PKPD of biologics is required.
Strong knowledge of laboratory techniques including cell culture, bioimaging, HPLC, radiochemistry (radiolabeling of biotherapeutics), animal studies, sample preparation, Immunoprecipitation, Western blot, and Lab safety is required
Experience in drug development preferably of biologics is required
Familiarity with relevant disease within a therapeutic area, knowledge of the PKPD of existing therapies as well as new treatment modalities.
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.
Who We Are
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.
The next step is yours. To apply today, click on the "Apply online" button.
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.