Ultragenyx

Outside Sales

• Make a difference for those who need it most
• Represent Ultragenyx in the Rare Disease Community
• Promote Dojolvi for the treatment of long chain fatty oxidation disorders (LC-FAOD)
• Prepare for the potential commercialization of two investigational novel gene therapies in MPSIIIA and GSD1a
• Drive change through innovative approaches
• Build strong business acumen
• Consistently deliver sales results

Liaison, Rare Disease Field Sales

Data Scientist

• Management of data management vendors providing consistent team direction/guidance and monitoring quality of work through vendor audits and key performance metrics.
• Development and maintenance of program level DM deliverable timelines in accordance with program development strategy. Actively drives internal and external timeline negotiations, as needed.
• Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.
• Facilitate cross-functional sponsor review meetings of eCRF design and edit check specifications.
• Facilitate and perform cross-functional sponsor EDC user acceptance testing.
• Facilitate the development of data transfer agreements with central/specialty labs and other external data vendors. Ensuring data quality from data capture to reporting.
• Facilitate the development and implementation of key data and metrics reports/listings.
• Perform sponsor review of DM essential documents including annotated CRFs, eCRF Completion Guidelines, Data Management Plans and DB Go Live and Lock documentation.

Senior Manager, Clinical Data Management

Director

• Lead in product / indication level tasks including regulatory interactions and filing, and ensure statistical integrity; contribute strategically to the supporting projects from statistics perspective
• Contribute to study level tasks from statistics perspective, including: study design and sample size determination; Author/review statistics section in the protocol, SAP and DMC charter; Create/review study randomization files; Develop TFL shell and specification Review CRFs and other study documentations; Active participation in study related meetings
• Works collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
• Ensure statistical integrity of deliverables; provide statistically sound scientific methodology input to meet project objectives and regulatory statistical and data requirements
• Independently conduct analyses suggested by the data; Propose new/novel statistical methodological approaches to improve the efficiency and sensitivity of study results
• Contribute to developing standards and research in advanced statistical methodologies
• Author/review regulatory documents or scientific publications
• Mentor junior team members

Director, Biostatistics

• Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups
• Ensure evidence strategy alignment throughout the development cycle for a program and across functions
• Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health)
• Provide input on the development of protocols, goals and endpoints tables, case report forms, IEPs, publications, Steering Committees and other relevant deliverables
• Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc
• Train and mentor cross-functional personnel working on DMPs as needed

Associate Director, Disease Monitoring Programs – Metabolic

Account Manager

• Early engagement planning: Define and execute sourcing strategies aligned to pipeline, portfolio priorities, and enterprise objectives.
• Vendor selection: Lead RFIs/RFPs, competitive bidding, vendor evaluations, bid defense strategy, and onboarding alignment for complex and high-impact initiatives to support fit-for-purpose vendor selection and successful engagement start-up.
• Contracting alignment: Lead alignment across scope, budget, and contracting considerations, ensuring consistency and scalability between operational requirements, financial assumptions, and vendor agreements.
• Strategic vendor partnership management: Serve as a senior strategic partnership lead for external GCP vendors across service categories, driving partnership alignment, performance expectations, strategic engagement, and ongoing relationship management across the vendor partnership.
• Governance & oversight: Lead governance forums and support timely escalation resolution through appropriate senior stakeholder engagement, while driving KPI/performance discussions, quality alignment, consistent oversight, accountability, and strategic alignment across partners.
• Sourcing and partnership optimization: Drive complex cross-program sourcing initiatives, vendor/category alignment activities, and partnership optimization efforts to establish consistency of sourcing and partnership approach, strengthen vendor engagement, and scale effective practices across programs and vendors.
• Lessons learned / continuous improvement: Drive continuous improvement by identifying cross-program insights, scaling best practices, and strengthening sourcing and partnership approaches across the portfolio.
• Stakeholder engagement: Engage and influence senior cross-functional stakeholders to support sourcing decisions, align vendor partnership strategy with execution needs, and drive strategic and portfolio alignment across programs and vendors.

Director, Development Sourcing – Partnerships

• Provide leadership and management to a National Field Team of Patient Access Liaisons (PALs).
• Establish performance and development goals for PALs and monitor their progress throughout the year
• Identify Access & Reimbursement trends and collaborate with cross functional team to address issues and in a timely manner and properly align resources (ROAR)
• Ensure all Patient Access Liaisons are capturing all relevant data correctly in Patient Relationship Management System
• Provide reporting metrics on a consistent basis in order to ensure all cases are moving along in a timely fashion
• Organize and lead weekly team meetings with PALs and weekly meetings with counterparts that lead the Patient Engagement Centers
• Monitor program processes to ensure there is efficiency and there is best in class customer experience
• Create documents such as standard operating procedures, work instructions, training decks, etc.
• Monitor all PALs reimbursement conflict resolution with their assigned accounts
• Work cross functionally with internal and external stakeholders on any future franchise products

Liaison, Rare Disease Field Sales

Senior Manager, Clinical Data Management

Director, Biostatistics

Associate Director, Disease Monitoring Programs – Metabolic

Director, Development Sourcing – Partnerships

Director, Patient Access – Reimbursement