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Senior Medical Director, Global Clinical Development

Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.   Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission - to make a difference in our patients' lives.   Come join our team during this exciting time of growth and opportunities! Position Summary ultracurious - Apply your biggest ideas in courageous ways This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in 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 bone 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. In this role you will interface with academic clinicians to effectively evaluate protocol strategies and publication to support product claims and marketing requirements. The incumbent will also participate in strategic planning and product development functions as necessary. One major responsibility will be serving as the physician lead for the Disease Monitoring Programs (DMP) for rare bone diseases. The DMPs are designed to be innovative, cutting edge research studies combining both in-clinic assessments and on-line patient reported experiences over a 10+ year time period. The DMPs will be the main data generation initiatives supporting our products through their life cycle.   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. Responsibilities including, but not limited to:  Manage the process for the company's clinical studies effort to ensure the highest level of success, efficiency of clinical protocols, FDA review and successful product launches  Successfully lead cross-functional teams focusing on clinical development strategy  Be an effective manager of physician scientists and/or clinical science specialists  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 Technical Requirements & Skills:  MD degree or MD, PhD degrees, graduating from a high quality medical school.  Minimum of 4 years of industry experience (rare disease experience preferred but not required)  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  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  Thought about adding something in support of DMPs and or other post-marketing initiatives.
Salary Range: NA
Minimum Qualification
5 - 7 years

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