Director Clinical Operations
vor 20 Stunden
**Why Join Us?**
- Be a hero for our rare disease patients_
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Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.
If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team
_. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing._
- US based roles:_
- Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation. _
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- Roles based outside the US:_
As the Director of Clinical Operations, you are accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs. You are accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. You will lead and/or sponsor Clinical Operations organizational initiatives.
**Responsibilities**:
- 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
- Oversee the development of study project plans, including timelines, metrics, budgets, and resources
- Develop and present operational plans to management
- Oversee the Clinical Operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets
- Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions
- Represent Clinical Operations on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc.
- Identify program risks, develop and implement mitigation strategies for assigned programs
- Manage and mentor Clinical Operations personnel
- Ensure employees and contractors are appropriately trained to comply with company and regulatory standards
- Develop and implement corporate and department organizational goals
- Lead working groups or initiatives
- Make recommendations to management on matters related to human resources, budget and department operations
- Recognized as an effective leader in Clinical Operations
- May be responsible for the following activities:
o Participate in and/or facilitate CRO/vendor selection process for outsourced activities
o Oversee CRO interactions, including sponsor oversight of operational functional activities, such as study management, training and monitoring
**Requirements**:
- Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
- 10+ years of progressively more challenging experience in clinical and drug development
- Prior management experience at the Associate Director/Directorlevel or equivalent
- Strong background in pharmaceutical and biotech clinical research. Rare disease clinical trial experience desired
- Demonstrated ability to lead development programs and study teams
- Ability to provide scientific and clinical expertise to a clinical development program
- Working knowledgeable of ICH GCP guidelines and FDA regulations 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
- Must have the ability to build and maintain positive relationships with management, peers, and direct reports
- Excellent written and verbal skills required. Must display strong analytical and problem-solving skills
- Willing to travel domestically and internationally
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