Associate Director, Disease Monitoring Programs (Metabolic)

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:

1. Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups 
2. Ensure evidence strategy alignment throughout the development cycle for a program and across functions 
3. Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health) 
4. Provide input on the development of protocols, goals and endpoints tables, case report forms, IEPs, publications, Steering Committees and other relevant deliverables 
5. Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc 
6. Train and mentor cross-functional personnel working on DMPs as needed 

Requirements:

1. Bachelor degree or equivalent required (scientific or healthcare discipline preferred) 
2. 7+ years of progressively challenging experience in clinical research and/or drug development 
3. Critical thinking skills coupled with innovative approaches to problem solving 
4. Comfortable managing and presenting to senior level stakeholders 
5. 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 
6. Ability to provide operational expertise to a clinical development program 
7. Working knowledgeable of regulatory agency regulations and ICH GCP guidelines is required 
8. Familiar with advanced concepts of clinical research (including complex study designs) and able to work effectively in a team/matrix environment  
9. Strong strategic planning and decision-making skills 
10. Ability to deal with time demands, incomplete information or unexpected events 
11. Excellent written and verbal skills required.  Must display strong analytical and problem solving skills   
12. Willing and able to travel domestically and internationally 
13. Rare disease clinical trial experience desired 

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