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Medical Director/Director Clinical Development, Global Clinical Development

Company: Ultragenyx Pharmaceuticals
Location: Novato
Posted on: September 11, 2020

Job Description:

Why Join Us?Be a hero for our rare disease patientsUltragenyx is a commercial-stage biopharmaceutical company committed to developing novel therapies for the treatment of rare and ultra-rare genetic diseases. 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 typically no approved therapies treating the underlying disease. -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' e join our team during this exciting time of growth and opportunities! During the COVID-19 Outbreak we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time our process will include WebEx video discussions, interviews & onboarding.Position Summaryultracurious - Apply your biggest ideas in courageous waysUltragenyx is looking for an experienced Medical Director 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 to ensure the highest level of success, efficiency of clinical protocols, FDA review and successful product launchesSuccessfully lead cross-functional teams focusing on clinical development strategyBe an effective manager of physician scientists and/or clinical science specialistsDirect and oversee phase three clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board (IRB) applications, training, monitoring, documentation and data analysisWork with current and future partners to initiate and monitor clinical studies including evaluationReviews and Approves procedures for the design and implementation of clinical protocols, data collection systems and final reportsEnsure that all clinical studies are appropriately designed and effectively executed and monitoredProvides safety surveillance guidance, acts as a medical monitor, and ensures adherence to cGCP requirements and all applicable regulatory references and guidelinesParticipate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as neededManage 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 budgetsRequirements:M.D. preferred, PhD/PharmD or equivalent degree with strong scientific background and/or drug development experience is accepted. Formal training in the areas of Pediatrics / Internal Medicine / Genetics / Bone and Metabolism / Endocrine / Neurology is desired.Minimum 3 years of industry experience -Early clinical stage development experience (preferred but not required)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 studiesExperience across all phases of clinical studies preferred, understanding and/or experience with post-approval commitments is an advantageAbility to write clinical study reports and summaries for regulatory purposes -#LI-TR1Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact -Talent Acquisition -by calling: -(415) 483-8800 -or by -emailing -us at -talentacquisition@. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.See our -CCPA Employee and Applicant Privacy Notice.See our -Privacy Policy.Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will -not create any implied obligation. -Inquiries on developing a recruiting relationship with us, may be directed to: -talentacquisition@.Novato, CA /Ultragenyx - Global Clinical Development /Full-time

Keywords: Ultragenyx Pharmaceuticals, Novato , Medical Director/Director Clinical Development, Global Clinical Development, Executive , Novato, California

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