Executive Director, Clinical Solutions & Compliance
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position can be located in Novato, CA or Brisbane, CA.
The Sr. Director/Executive Director of Clinical Solutions & Compliance is accountable for defining the vision, mission and strategy for the function, which resides in the Clinical Operations organization. This position has responsibility for overseeing clinical systems, training programs and implementing appropriate processes and procedures to ensure GCP compliance and inspection readiness within Clinical Operations. The Sr. Director/Executive Director will also sponsor and/or lead key strategic Clinical Operations organizational initiatives.
Responsibilities, including but not limited to:
- Build and lead the Clinical Solutions & Compliance team to create, deploy and manage Clinical Operations’ systems, process and procedures, training programs, GCP compliance and regulatory inspection activities
- Oversee the development and deployment of Clinical Operations’ Policies, Quality Standards and Standard Operating Procedures in accordance with ICH/GCP regulations and company policies to ensure inspection readiness
- Ensure optimal relationships with key internal stakeholders, as well as vendors, to enable the successful development and deployment of Clinical Operations and cross-functional Development processes, clinical systems, quality documentation and training programs, as appropriate
- Represent Clinical Operations on the Inspection Readiness Steering Committees
- Partner with Clinical Quality Assurance to oversee GCP regulatory authority inspections on behalf of Clinical Operations
- Provide oversight and strategic guidance for key clinical systems, such as eTMF, CTMS and IWRS
- Actively participate as a member of the Clinical Operations Leadership Team in the development of organizational goals and strategies
- Lead key strategic Clinical Operations organizational initiatives by translating the vision into actionable strategies and ensuring that plans are executed per commitments. Includes the identification of process challenges, process enhancement, and training of teams
- Accountable for the line management of Clinical Solutions & Compliance staff, including development, coaching, talent planning and performance management.
- Provide input to and rationale for department budget and maintain control of functional expenditures against department budget
- Develop and present strategic and operational plans to senior management
- Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
- 16+ years of experience in Clinical Research
- Ideal candidate will have demonstrated ability in the following areas: GCP regulatory authority inspections, process development & improvement, training & development, development of a clinical compliance function and clinical systems
- Experience developing and leading a clinical risk management function and the ability to demonstrate an understanding of a clinical quality management system
- Previous experience in managing a group or business unit, including the management of budgets, timelines and resources
- Strong working knowledge and interpretation of FDA/EU and ICH – GCP regulations and guidelines
- Broad and direct experience with regulatory authority inspections, including both FDA and EMA inspections
- 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 senior management, peers, and direct reports
- Focused on practical, commonsense and sensible approaches to finding effective solutions with a focus on embedding strong quality and compliance behaviors
- Willingness to work in a dynamic and changing corporate environment
- Previous experience leading key strategic functional initiatives
- Willing to travel domestically and internationally, as needed
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.