Director, Disease Monitoring Programs, Neurology (Remote)

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

The Director 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 Director of DMPs 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, Integrated Evidence Plans, 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. 10+ 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 knowledge of regulatory agency regulations and ICH GCP guidelines is required 
8. Strong strategic planning and decision-making skills 
9. Excellent written and verbal skills required.  Must display strong analytical and problem solving skills   
10. Willing and able to travel domestically and internationally 
11. Rare disease clinical trial experience desir