Director, Regulatory Affairs
Veristat
Google Cloud Platform
Director, Clinical Operations
Ultragenyx
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $196,900 - $243,200 per year
Job Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Position Summary: The Director of Clinical Operations is accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs.
- Work Model: Remote—Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
- Lead the operational strategy and functional management for one or more clinical trial programs, in accordance with the Clinical Development Plans and program plans
- Accountable for the development and implementation of clinical development program strategies; planning horizon is typically 12-24 months
- Develop and present operational plans to management including risk management and mitigation
- Accountable for the development, implementation and execution of clinical trials within agreed timelines, resources and budgets (including proactive planning and management)
- Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions (and all study related documents as needed)
- Represent Clinical Operations on the project teams, such as the Development Sub-Team, Core Teams (as applicable)
- Identify program risks, develop and implement mitigation strategies for assigned programs
- Manage and mentor Clinical Operations personnel
- Oversee vendor interactions (from selection through to close) and being a point of escalation for the operational functional activities and identify key risks. Experience working with internal partners (Vendor Management, Finance etc) in the overarching management of the vendors
Requirements
- Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
- 12+ years of progressively more challenging experience in clinical and drug development
- Prior management experience at the Associate Director level or equivalent
- Demonstrated ability to lead development programs and study teams
- Experience with international trials
- Rare disease clinical trial experience desired
- Ability to provide scientific and clinical expertise to a clinical development program
- Working knowledgeable of FDA 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
- Willing to travel domestically and internationally
