Director, Global Clinical Development, Neurology at Ultragenyx in Brisbane, CA

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

Ultragenyx is looking for an experienced clinical development physician with the passion and creativity to develop great medicines for rare and ultra-rare diseases. The ideal 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 therapies to patients around the globe who have no approved therapies for their disease.

The individual will be an initiative-taker with excellent management and leadership capabilities who is seeking to lead and be part of an innovative team that will drive the drug development processes from start to finish. Reporting into the SVP, Global Clinical Development and Therapeutic Area Head for Neurology, the individual will be responsible for the development and execution of clinical studies. The individual will conduct medical monitoring, contribute to study design, and clinical development strategy. This position will serve as a key liaison between the company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.

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.

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

Responsibilities:

Direct and oversee clinical studies at multiple phases of clinical development, including clinical strategy, study design, protocol writing, Institutional Review Board (IRB) applications, site training, medical monitoring, documentation and data analysis
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; maintain an ongoing assessment of the safety profile and efficacy data.
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 to support understanding of the candidate drug effects and to gain strategic insights to the further development of study and overall program.
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
Reviews and Approves procedures for the design and implementation of clinical protocols, data collection systems and final reports
Ensure that all clinical studies are appropriately designed and effectively executed and monitored
Provides safety surveillance guidance, acts as a medical monitor, and ensures adherence to cGCP requirements and all applicable regulatory references and guidelines
Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed
Manage 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 budgets

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. 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 studies
Experience across all phases of clinical studies required, understanding and/or experience with post-approval commitments is an advantage
Ability to write clinical study reports and summaries for regulatory purposes #LI-CS1 #LI-Hybrid

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$279,800—$345,700 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · 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 * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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