Vice President, Global Clinical Development, Neurology

Summary

Join Ultragenyx as the Head of Neurology Therapeutic Area, Vice President of Global Clinical Development. Lead a neurology portfolio with several clinical programs and support early clinical collaborations. This physician-scientist role requires leadership experience in global drug development, specifically in rare disorders, with expertise in neurology, pediatrics, and genetics. You will manage, develop, and execute multiple clinical research and post-commercial programs. This is a high-visibility role involving interactions with regulatory officials, thought leaders, and investigators. The position offers a remote work model with occasional travel.

Requirements

• M.D. or equivalent degree is required. Training in Neurology/Pediatric Neurology or significant experience in neurogenetic development programs is required
• 8 + (10 + preferred) Clinical and managerial experience in drug development in rare disease with significant experience with pivotal studies and health authority interactions in industry
• Experience with trials though NDA / BLA
• Exceptional analytical skills with experience in translational tools, biomarker and endpoint development, study design and statistical methodology
• Excellent interpersonal and public speaking skills are required for this high visibility position
• Demonstrated ability to work in a matrix environment with cross-functional teams
• Up to 20% annual travel (domestic and international) is required for this position

Responsibilities

• Lead the authoring of fully integrated clinical development plans for the Neurology portfolio, including direct and oversee the overall strategy for clinical drug product development and collaborate with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports and lead the clinical aspect of interactions with regulatory agencies worldwide
• Direct involvement in trial design of Phase I/II/III/IV research trials and disease monitoring programs in CNS/Neurology Therapeutic Area
• Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs
• Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program
• Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges
• Design and develop clinical study protocols and associated clinical study documents and monitor required documentation in compliance with clinical development plans, GCP, and good medical practice
• Participate in the selection of clinical investigators; providing guidance to investigators on a study and provide medical supervision for contract research organizations and protocol procedures
• Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory values; maintaining an ongoing assessment of the safety profile, and efficacy data and medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups
• Assist with due diligence of new scientific developments
• Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees/task group and collaborate on overall company strategy and in licensing of new programs
• Work with the financial group as needed to assist with the production of budgets and timelines for the clinical development team
• Ensure that operational activities are conducted in compliance with all pertinent regulatory or statutory requirements and in accordance with the scientific standards, ethical and professional values, management philosophy, and established priorities, policies, and practices of the Company

Preferred Qualifications

• Technical (Medical and Scientific) experience evaluating targets/agents for in-licensing or internal development desirable
• Experience supervising physicians and/or scientific staff in a management or team leader capacity highly desirable

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
• Annual bonus and equity incentives