Preferred Degree: Doctorate
Job Type: Full Time
Experience (Years): 8-10
Job Category: Clinical Development/Affairs
Why Join Us
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rate and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. We are launching five Phase 2 clinical trials and with another preclinical trial in the pipeline. Where possible, our strategy is to acquire and retain global commercialization rights to our products. Come join our team during this exciting time of growth. We are located in Novato, CA, 28 miles north of San Francisco.
This unique opportunity reporting to the Vice President, Clinical Development, will work on developing life transforming therapeutics for patients with rare diseases. Ultragenyx is looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare diseases, including muscle diseases and biochemical genetic diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate monitoring and management of clinical studies of designed to support regulatory submissions seeking market approval in the US and worldwide. Interfaces with academic clinicians to effectively evaluate protocol strategies and publication to support product claims and marketing requirements. Participates in strategic planning and product development functions as necessary.
Ultragenyx is looking for an experienced physician with the passion and creativity to develop great medicines for rare and ultra-rare diseases. The individual will be a self-starter with excellent clinical capabilities and who is seeking to be part of an innovative team that will drive the drug development processes from start to finish. The successful candidate will be ready for a career defining experience and have the passion to drive a number of therapeutics for devastating diseases to final approval.
• Manage the process for the company's clinical studies effort to ensure the highest level of success, efficacy of clinical protocols, FDA review and successful product launches
• Direct and oversee clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board (IRB) applications, training, monitoring, documentation and data analysis
• 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
• MD degree or MD, PhD degrees, graduating from a high quality medical school.
• Must have completed clinical training in a quality clinical residency program, be licensed in at least one state in the US
• Must be originally boarded in a medical specialty; optimally in medical genetics, pediatric or adult neurology or other complex clinical fields dealing with chronic diseases and complex pathophysiology, or relevant experience.
• 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
• Proven leadership experience and able to work both independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.
• Must be analytical and articulate in both oral and in writing skills, with a demonstrated ability to communicate well with others at varying professional levels, especially in the medical profession.
• Ability to write clinical study reports and summaries for regulatory purposes
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public