Lead Clinical Scientist

Genentech•Daly City, CA

1d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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.