Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Direct and oversee clinical studies at multiple phases of clinical development, including clinical strategy, study design, protocol writing, Institutional Review Board (IRB) applications, site training, medical monitoring, documentation and data analysis
• Inspire a cross-functional team to promote high performance and keep team members focused on the highest priority activities for study execution
• Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory values; maintain an ongoing assessment of the safety profile and efficacy data.
• Lead cross-functional teams focusing on clinical development strategy
• Work closely with all functions of the organization and external partners to manage trial logistics.
• Review and contribute to the creation of study materials, including informed consent forms, electronic case report forms, and periodic safety reports
• Critical review and scientific contribution to clinical study reports and manuscripts
• Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program.
• Work with the clinical operations and finance teams to assist with the production of budgets and timelines for clinical trials.
• Identify opportunities for external collaboration.
• Assist with due diligence of new scientific developments.
• Work with current and future partners to initiate and monitor clinical studies including evaluation
• Reviews and Approves procedures for the design and implementation of clinical protocols, data collection systems and final reports
• Ensure that all clinical studies are appropriately designed and effectively executed and monitored
• Provides safety surveillance guidance, acts as a medical monitor, and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines
• Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed
• Manage outside consultants (consultants, etc.) to ensure data is accurately collected and analyzed in a cost effective fashion
• Exhibits leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction)
• Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies that are efficient in time and money, and hedge risk as needed.
• Review and approve proposals for appropriate personnel assignments, time allocations, and budgets

Requirements:

• MD degree or equivalent (e.g., MBBS), MD/PhD degree is a plus; graduating from a high-quality medical school.
• Minimum 2 years of industry experience or leadership of industry-sponsored clinical trials
• Must be originally boarded in a medical specialty; optimally in neurology or pediatrics, or other complex clinical fields dealing with rare, chronic diseases and complex pathophysiology.
• Must be trained in GCP regulations, and be familiar with relevant ICH and FDA guidelines relevant to clinical development. Must have experience designing successful clinical studies in complex diseases requiring the management of patient variation, chronic irreversible disease and related complexities. Must be facile with statistical issues and be able to manage working with a statistician to design the analysis of clinical studies
• Experience across all phases of clinical studies required, understanding and/or experience with post-approval commitments is an advantage
• Ability to write clinical study reports and summaries for regulatory purposes #LI-CS1  #LI-Hybrid