Associate Director, Disease Monitoring Programs (Metabolic)
UltragenyxAbout the role
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
The Associate Director (AD) of Disease Monitoring Programs (DMPs) is a visible leadership role accountable for the strategic planning and oversight for one or more assigned DMPs. DMPs are a novel approach to GCP-compliant long-term data collection for rare diseases from pre-approval through post marketing. The AD will collaborate with other functional leaders at both tactical and strategic levels.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
Responsibilities:
- 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, IEPs, 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)
- 7+ 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 knowledgeable of regulatory agency regulations and ICH GCP guidelines is required
- Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment
- Strong strategic planning and decision-making skills
- Ability to deal with time demands, incomplete information or unexpected events
- Excellent wr
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