Google Cloud PlatformStatistical AnalysisGCPGoogle CloudProject ManagementCommunication
About this role
Role Overview
Independently leads clinical execution of one or more studies; may be accountable for program level clinical deliverables.
May provide input to the protocol design document; leads development of the protocol, including protocol amendments.
Represents the study team in internal protocol review governance submissions and interactions; partners with/supports the Global Development Lead in study and disease area strategy.
Ensures development of Study Informed Consent Documents and responses to external stakeholder requests.
Provides clinical guidance to the development of the Statistical Analysis Plan.
Requirements
Science degree (PhD, PharmD, or equivalent) with at least 5 years, or MA/MS with at least 7 years, or BA/BS with at least 8 years of Clinical Research experience in a similar role in the biopharmaceutical industry.
Cardiometabolic disease experience, e.g., obesity, diabetes, endocrinology, etc.
Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspection.
Scientific productivity via publications, posters, abstracts and/or presentations.
Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP.
Clinical and project management capabilities; effective verbal and written communication skills.
Experience launching, managing, and training clinical development teams.
Tech Stack
Google Cloud Platform
Benefits
Health benefits to include medical, prescription drug, dental and vision coverage.