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!
Our headquarters is located in Novato, CA, 25 miles north of San Francisco and we have an office in Brisbane, CA.
This is a unique opportunity to join a clinical-stage biotech company focused on developing life transforming therapeutics for patients with rare and ultra-rare diseases. Ultragenyx is looking for an experienced leader with the passion and creativity to develop great medicines for rare and ultra-rare diseases.
In this role, the Executive Director / Vice President of Clinical Data Management (CDM) is fully accountable for all clinical data management activities in support of the clinical pipeline. This includes, but is not limited to, execution and ownership of the CDM operating model; oversight of internal staff and external CDM partners; leadership in technical innovation related to CDM.
• Develops, maintains, and supervises the Data Management group to carry out the company’s objectives
• Establishes objectives, and annual goals, provides leadership, direction and development opportunities to the staff
• Development of DM personnel with focus on leadership skills and best practice expertise
• Drives overall Data Management strategy and collaborates with others to lead operational cross-functional initiatives.
• Prioritization and project management of work, staff allocation and budget to deliver within a highly dynamic environment.
• Manage outsourcing providers and preferred partnerships and collaboration activities for DM including proper oversight activities, performance metrics, continuous improvement, and established alliance governance.
• Commitment to building and maintaining high quality systems, processes and procedures in alignment with Good Clinical Practice (GCP) and Good Clinical Data
• Management Practices (GCDMP) in order to provide data of excellent quality to inform decision making.
• Strategic oversight of technology platforms related to EDC, data visualization, programming, and risk based monitoring.Innovate at the speed of technology to identify and implement emerging new ways of doing DM as appropriate.
• Deliver high quality EDC databases, ensuring flawless execution during clinical study conduct, and providing the clinical team with analysis ready and reliable data after database lock.
• Development, maintenance and governance of DM standards (custom eCRF or CDASH etc.).
• Champions development and implements of high quality controls and departmental standards such as of policies, guidelines and processes to ensure adherence to the company’s expectations and regulatory requirements
• Maintain external awareness and engagement regarding the DM space.
• Ensure clinical data is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.
• Participate in cross-functional review meetings
• Proactively identifies potential study issues/risks and recommend/implements solutions and contributes to the solution process for data issues
• Prepares and/or reviews/approves study-related documents , such as DM plan, CRF completion Guidelines, etc.
• Master’s degree or higher; 12+ years of related clinical trial data management and clinical operations experience (10+ years with advanced degree)
• Proven Leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment is required
• Proving track record of developing data management groups
• Deep subject matter expertise in Data Management and associated technologies and processes.
• Extensive knowledge of GCP, GCDMP and other relevant ICH/regulatory guidelines.
• Demonstrated experience leading and/or building a Clinical Data Management group and/or function.
• Experience with successful oversight of vendor/strategic partner relationships, including significant outsourced operations, and proven track record of ensuring quality deliverables or services in a cost effective manner.
• Experience with Clinical Database Management Systems, particularly Electronic Data Capture (EDC) including knowledge of one or more Clinical Database Management Systems
• In-depth knowledge of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines, as related to data integrity
• Must have the ability to build and maintain strong positive relationships with management, peers, and direct reports
• Must display strong analytical and problem solving skills. Attention to detail required.