Genentech’s Research and Early Development (gRED) Early Clinical Development (ECD) organization is responsible for developing and executing early development clinical strategies and plans to provide proof-of-concept data with respect to safety, efficacy, and the utility of biomarkers for gRED new molecular entities. The Lead Clinical Scientist participates in development of clinical strategies for assigned molecule(s)/indication(s) and is responsible for developing and effective and efficient execution of the Clinical Development Plan (CDP) for one or more molecules. Lead Clinical Scientists are expected to perform their responsibilities independently, have core knowledge of the CS function to enable increased participation in department level initiatives, and may contribute to complex projects with supervision.
The Opportunity:
Your responsibilities in this role will include:
Contributes as a standing member of the Clinical Science Sub-Team.
Drives authoring, review and team decisions required to develop study protocols, ICFs, and study start-up documents documents requiring clinical expertise.
Conducts medical data review.
Processes and conducts regular review and analysis of protocol deviations.
Primary POC for protocol-related inquiries from internal colleagues and external sites.
May author, in collaboration with relevant team members and/or support functions, clinical sections of regulatory documents, or responses to healthy authority (HA) or ethics committee inquiries
Collaborates cross-functionally to develop simplified/novel/fit-for-purpose presentation of study data.
Who You Are:
Advanced clinical/science degree preferred (PharmD, PhD, MSN, MPH, etc.)
4 or more years pharma/biotech industry experience preferred
Has experience working in complex matrixed setting(s)
Experience with cross-functional authoring full clinical trial protocols
In-depth understanding of drug development
Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance
Relocation benefits are not available for this posting.
Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week.
The expected salary range for this position based on the primary location of South San Francisco, California is $141,000- $261,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
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