About the role
Position Summary:
ultrainnovative – Tackle rare and dynamic challenges
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.
Work Model:
Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
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
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
