Medical Director

Summary

Join Ultragenyx, a leading biotechnology company in rare disease development, as a Physician-Scientist in the Neurology Therapeutic Area. This role involves medical monitoring of clinical trials, contributing to study design and strategy, and collaborating with key stakeholders. You will provide medical and scientific input on clinical data, safety profiles, and regulatory inquiries. The position requires experience in clinical development, translational research, and a strong understanding of GCP regulations. This remote position offers a competitive salary, annual bonus, equity incentives, and a comprehensive benefits package.

Requirements

• MD or MD/PhD
• Originally boarded in neurology (peds or adult) or pediatrics with clear record of neuroscience research
• Academic scientific research in a related field
• Trained in GCP regulations, familiar with ICH and FDA guidelines relevant to clinical development
• Experience designing successful clinical studies in complex diseases requiring the management of patient variation, chronic irreversible disease and related complexities
• Facile with statistical issues to collaborate with a statistician to design the analysis of clinical studies
• Travel to study sites, team meetings, scientific conferences, and patient organization meetings approximately 1-2 times per quarter
• Ability to integrate and interpret complex clinical data and present them succinctly and clearly to an audience
• Actively listen to and value others’ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others
• Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others

Responsibilities

• Perform medical monitoring for ongoing clinical trial(s)
• 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
• Support study execution, including review and cleaning of study data, updating study protocols, reviewing consent forms and other patient-facing materials, reviewing electronic case report forms, reviewing periodic safety reports, and training study sites
• Formulate clinical responses to regulatory, institutional review board (IRB) and ethics committee (EC) inquiries
• Formulate first-in-human concepts and study protocol design and present to corporate governance for approval
• Author early clinical development plans and present to corporate governance for approval
• Exhibit leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction). Inspire a cross-functional team to promote high performance and keep team members focused on the highest priority activities for study
• Critical review and scientific contribution to clinical study reports and manuscripts
• Work with the clinical operations and finance teams to assist with the production of budgets and timelines for clinical trials
• Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed

Preferred Qualifications

Prefer 2-3 years of industry experience or leadership of industry-sponsored clinical trials

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