Associate Director, Disease Monitoring Programs (Metabolic)

Ultragenyx Pharmaceutical

10d•$187,300 - $231,300•Remote

About The Position

The Associate Director (AD) 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 AD will collaborate with other functional leaders at both tactical and strategic levels.

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

Nice To Haves

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, 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