Associate Director, Disease Monitoring Programs (Metabolic)

Position Summary

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.

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 knowledge 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 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

Pay Range

The typical annual salary range for this full-time position is $187,300 - $231,300 USD. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.