Remote Director, Global Clinical Development, Neurology

Summary

Join our team at Ultragenyx as we tackle rare and dynamic challenges in the field of clinical development. We're seeking an experienced clinical development physician with a passion for developing great medicines for rare and ultra-rare diseases. As a key member of our innovative team, you'll lead and be part of driving drug development processes from start to finish.

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

Responsibilities

• Direct and oversee clinical studies at multiple phases of clinical development
• 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
• 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
• 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

Benefits

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans