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Associate Scientist/Scientist, Clinical Pharmacology

South San Francisco, California


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The Position

The Clinical Pharmacology Associate Scientist/Scientist (CP 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). Performs other duties as assigned.

Technical Skills:

Familiarity with quantitative approaches in drug development, working knowledge of relevant modeling software (eg. NONMEM, ADAPTII, WinNonlin, Berkeley Madonna, R, S-Plus, SimCYP, GastroPlus) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses. Familiarity with clinical study design options, especially for phase 1 and 2 studies. Working knowledge of statistical approaches as they apply to clinical study design & analysis. Working knowledge of relevant disease areas.

Communication Skills:

The CP Scientist requires excellent communication skills, both written and oral, in order to deliver high quality protocols, regulatory documents, documents for team and management review, scientific manuscripts & posters for publication.

Drug Development Knowledge:

The CP Scientist requires relevant experience/knowledge of how CP science can impact drug development. CP Scientist should have a good knowledge of GCP and working knowledge of relevant regulatory guidelines.

Leadership:

Based on experience and ability, the CP Scientist may lead CP teams, project sub-teams and represent CP at cross-functional project teams. Based on experience and ability, the CP Scientist may manage other Scientists or Research Associates within CP department.

Qualifications:

  • MD, PhD, PharmD or equivalent
  • Multiple levels based on relevant experience in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related quantitative discipline.
    • Associate Scientist 0-3 years of experience
    • Scientist 3-5 years of experience

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Who We Are

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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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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