Ultragenyx

Clinical Operations

• Position Summary: The Director of Clinical Operations is accountable for the operational strategic planning, oversight and delivery for one or more assigned clinical programs.
• Work Model: Remote—Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
• 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
• Develop and present operational plans to management including risk management and mitigation
• Accountable for the development, implementation and execution of clinical trials within agreed timelines, resources and budgets (including proactive planning and management)
• Provide input on the development of protocols, Case Report Forms, Clinical Study Reports, and regulatory submissions (and all study related documents as needed)
• Represent Clinical Operations on the project teams, such as the Development Sub-Team, Core Teams (as applicable)
• Identify program risks, develop and implement mitigation strategies for assigned programs
• Manage and mentor Clinical Operations personnel
• Oversee vendor interactions (from selection through to close) and being a point of escalation for the operational functional activities and identify key risks. Experience working with internal partners (Vendor Management, Finance etc) in the overarching management of the vendors

Director, Clinical Operations

Financial Planning and Analysis

• Lead the development, implementation, and execution of the enterprise-level annual budget and forecast updates, long-range strategic financial plans (e.g., 5-year plan), and assessing and preparing for alternate scenarios, ensuring alignment with corporate strategy and business objectives • Partner with senior leadership across R&D, Commercial, Technical Operations, and Corporate Functions to develop robust financial models and provide strategic financial input for key decision-making, resource allocation, and investment prioritization • Oversee the preparation and presentation of detailed financial reports, analyses, and dashboards to senior management, the executive leadership team, and the Board of Directors, providing clear, concise, and actionable insights • Provide strong leadership in guiding the FP&A team to deliver high-quality financial analysis and insights that support strategic decision-making • Maximize use of current technology and drive adoption of new advanced technologies as needed • Challenge the status quo and identify opportunities for process optimization and efficiency within financial planning and analysis • Collaborate effectively with Accounting, Treasury, Investor Relations, Business Development, and other functional leads to ensure seamless financial operations and data integrity • Act as a key finance partner to business leaders, providing financial expertise and support for strategic initiatives • Serve as Finance representative to one or more of our project teams, providing analytical and strategic support

Senior Director, Corporate Financial Planning and Analysis

Medical writer

• The Medical Writer is responsible for writing and overseeing the writing of various clinical and regulatory documents. The position works closely with the cross-functional team to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals.
• The core duties of the medical writing manager are delineated below.
• Work Model: Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.
• Responsibilities:
• Write, edit, or collaborate on development of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
• Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
• Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required and ensure adherence to standards
• Distill large amounts of clinical and scientific data into essential elements for graphical display
• Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams
• Formulate key messages from clinical study data
• Perform literature-based research to support writing activities
• Develop and maintain templates and outlines for key documents

Director, Clinical Operations

Senior Director, Corporate Financial Planning and Analysis

Medical Writer (Clinical and Regulatory)