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Associate Director, Disease Monitoring Programs – Metabolic
UltragenyxAssociate Director of Disease Monitoring Programs at Ultragenyx Pharmaceutical. Responsible for strategic planning and oversight of DMPs for rare diseases.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchdrug developmentdata generationregulatory complianceICH GCP guidelinesclinical trial designprotocol developmentcase report formsevidence generationfinancial health monitoring
Soft Skills
critical thinkingproblem solvingstrategic planningdecision-makingcommunicationmentoringteam collaborationpresentation skillsanalytical skillsadaptability