Google Cloud PlatformGCPGoogle CloudStrategic PlanningCritical ThinkingProblem Solving
About this role
Role Overview
Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups
Ensure evidence strategy alignment throughout the development cycle for a program and across functions
Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health)
Provide input on the development of protocols, goals and endpoints tables, case report forms, Integrated Evidence Plans, publications, Steering Committees and other relevant deliverables
Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc.
Train and mentor cross-functional personnel working on DMPs as needed
Requirements
Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
10+ years of progressively challenging experience in clinical research and/or drug development
Critical thinking skills coupled with innovative approaches to problem solving
Comfortable managing and presenting to senior level stakeholders
Comprehensive understanding of high-quality data generation appropriate for regulatory, scientific, payer, physician and patient requirements to advance the understanding of rare diseases and their treatment/management
Ability to provide operational expertise to a clinical development program
Working knowledge of regulatory agency regulations and ICH GCP guidelines is required
Strong strategic planning and decision-making skills
Excellent written and verbal skills required
Must display strong analytical and problem solving skills
Willing and able to travel domestically and internationally
Rare disease clinical trial experience desired
Tech Stack
Google Cloud Platform
Benefits
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings