Director, Disease Monitoring Programs, Neurology (Remote)

Ultragenyx Pharmaceutical

6h•Remote

About The Position

At Ultragenyx, we are dedicated to leading the future of rare disease medicine by taking impactful action to care for patients and our people. We challenge the status quo by creating a new model that advances the field, enabling more patients and caregivers to benefit from life-changing treatments. Our approach involves following the science, employing a rapid development methodology, creating innovative medicines at fair prices, and fostering a collaborative ecosystem to reach patients meaningfully. Our commitment to patients extends to our employees, with a focus on creating a supportive and inclusive environment for profound learning and growth, allowing employees to thrive in all aspects of their lives. We aim to be an organization where our family, friends, and children would be proud to work. If you seek to make a meaningful impact, achieve your career best, and grow professionally and personally, join our team. The Director of Disease Monitoring Programs (DMPs) is a key leadership role responsible for the strategic planning and oversight of one or more assigned DMPs. DMPs represent a novel approach to GCP-compliant long-term data collection for rare diseases, spanning from pre-approval through post-marketing phases. The Director will collaborate with other functional leaders at both tactical and strategic levels.

Requirements

Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
10+ 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 knowledge of regulatory agency regulations and ICH GCP guidelines is required
Strong strategic planning and decision-making skills
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

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, Integrated Evidence Plans, 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