Associate Director, Disease Monitoring Programs (Metabolic)

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 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
• #LI-CS1 #LI-Remote
• This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
• Pay Range
• $187,300 - $231,300 USD
• Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Benefits vary by region and country
• Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful di

Benefits

Additional Information

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: ultra innovative - Tackle rare and dynamic challenges The Associate Director (AD) of Disease Monitoring Programs (DMP s ) 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.

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