Ultragenyx is looking for an experienced clinical development physician and leader with a passion and creativity to develop great medicines for rare and ultra-rare diseases.  The idea candidate is a neurologist (adult or pediatric) with experience in the conduct and oversight of clinical trials  who is enthusiastic about applying their knowledge to bring new therapties to patients around the globe who have no approved therapies for thei disease.

The Senior Vice President  - Neurology Therapeutic Area Lead will be a hands-on global clinical development leader who will direct clinical activities for the neurology therapeutic area.  The individual will have the opportunity to provide clinical and operational leadership for the teams developing treatments for rare genetic diseases within the therapeutic area using one or more of our several therapeutic modalities.

This role will play an essential part within the CMO leadership team and development leadership forum, with strategic and technical influence on drug development; as well as beingan important member of several governance forums as an important contributor to the strategic planning of all phases of development.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Lead the clinical teams within the therapeutic area. As the clinical development therapeutic area leader, identify and advance programs from our Translational Research programs and through collaboration with the Business Development Team
• Provide clinical input, including trial design, medical monitoring, and regulatory submission preparation, and managing the selection of clinical consultants and investigators
• Review and refinethe clinical development protocols and plans and collaborate with colleagues in Clinical Operations and other Ultragenyx departments to ensure that the clinical goals for the Therapeutic Area programs are met
• Direct the overall strategy for clinical drug product development and work with Regulatory department in IND, CTA, and NDA submission activities and submission of IND safety reports
• 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
• Plan and lead groups to create clinical trial and protocol designs
• Participate in the selection of clinical investigators; provide guidance to investigators on studies
• Provide medical guidance for contract research organizations and protocol procedures
• Analyze study data for abstracts or publication
• Work with the finance team to help produce budgets and timelines for the clinical development team
• Ensure that operational activities are conducted in compliance with all important regulatory or statutory requirements and following the scientific standards, ethical and professional values, management philosophy, and established priorities and policies of the Company, and in close understanding of other R&D leadership team members
• Support due diligence activities of new scientific developments
• Develop medical and scientific talent within the group and to support the strategies of the Company

Requirements:

• Minimum of 15 years of Clinical Development experience at strategic and operational levels in the biotech or pharmaceutical industry or as a senior clinician in an academic setting. Experience rare diseases
• Neurologic background and a minimum of 10 years of experience in designing and managing clinical trials. Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
• MD required
• Significant expertise in clinical development, and administration and execution of clinical programs
• Demonstrated experience in complex trial design
• Experience with the full range of drug development from Phase 1-3 and post-marketing
• Experience working with our team members (key opinion leaders, co-development partners, contract manufacturing organizations, CROs, consultants, vendors)
• Experience with international trials
• Participation in a clinical trial program resulting in a successful NDA
• Proficiency in the implementation and monitoring of clinical trials, timelines, and budgets
• Direct experience supervising and managing clinical personnel and CRO relationships
• Ability to travel, consistent with project needs #LI-CS1  #LI-Hybrid