Temporary - Senior Clinical Program Manager
Novato, CA or Brisbane, CA
Ultragenyx – Clinical Operations
Why Join Us?
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, and Basel, Switzerland. This position can be located in Novato or Brisbane.
The Senior Clinical Program Manager (CPM) is accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs. The Senior CPM is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Senior CPM also participates in functional governance, including resourcing and staffing. The core duties and responsibilities of the Senior CPM include, but are not limited to:
- Lead the development and execution of operational strategies in accordance with the Clinical Development Plans and program plans
- Lead the Clinical Operations team to ensure effective development, implementation and execution of clinical trials within agreed timelines, resources and budgets
- Participate in the development of protocols, Case Report Forms, Clinical Study Reports, and NDA/BLA submissions, as appropriate
- Evaluate resourcing needs for assigned clinical program(s)
- Oversee program timelines and budgets
- Identify program risks, develop and implement mitigation strategies for assigned program(s)
- Represent Clinical Operations on the Development Sub-team, as applicable
- Prepare metrics and updates for management
- Oversee the CRO/vendor selection process for outsourced activities
- Oversee CRO interactions, including sponsor oversight of operational functional activities, such as study management, training and monitoring
- Ensure employees and contractors are appropriately trained to comply with company and regulatory standards
- Participate in the development and implementation of corporate and department organizational goals
- Participate in and/or lead working groups or initiatives, as required
- Manage and mentor Clinical Operations staff
- Bachelor degree or equivalent required (scientific or healthcare discipline preferred)
- Previous experience in clinical and drug development, including the management of clinical trials and clinical programs
- Previous experience in a supervisory role
- Working knowledgeable of FDA/EU regulations and ICH GCP guidelines is required
- Experience with international clinical trials
- Rare disease clinical trial experience desired
- Proven ability to lead a study team
- Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment
- 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.