Ultragenyx Pharmaceutical, founded in 2010, is a biotechnology company that specializes in bringing products to market to treat rare, ultra-rare, and serious ge
Associate Director, Disease Monitoring Programs – Metabolic
Location
United States
Posted
1 day ago
Salary
$187.3K - $231.3K / year
Seniority
Senior
Job Description
Associate Director, Disease Monitoring Programs – Metabolic
Ultragenyx Pharmaceutical
• 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
Job 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
Benefits
- 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
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