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:

ultracurious – Apply your biggest ideas in courageous ways

Ultragenyx is looking for an experienced physician with the passion and creativity to develop great medicines for rare and ultra-rare diseases. The individual will be a self-starter with excellent clinical capabilities and who is seeking to be part of an innovative team that will drive the drug development processes from start to finish. The successful candidate will be ready for a career defining experience and have the passion to drive a number of therapeutics for devastating diseases to final approval.

Work Model:

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

Responsibilities:

• Manage the process for the company's late stage development clinical studies effort to ensure the highest level of success, efficiency of clinical protocols, FDA review and successful product launches
• Successfully lead cross-functional teams focusing on clinical development strategy
• Be an effective manager of physician scientists and/or clinical science specialists
• Direct and oversee phase three clinical studies, including clinical strategy and design, protocol writing, Institutional Review Board (IRB) applications, training, monitoring, documentation and data analysis
• 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 MD, PhD degrees, graduating from a high quality medical school.
• Post Residency or Fellowship in metabolic bone diseases, experience or research interest in bone
• Minimum 1-2 years of industry experience
• Interest in career progression and ability to take on a more senior roles in 1-3 years
• Late stage development experience (preferred but not required)
• Must be originally boarded in a medical specialty; optimally in medical genetics, pediatric or adult neurology or other complex clinical fields dealing with chronic diseases and complex pathophysiology, or relevant experience.
• 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-Remote

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

$256,500—$316,900 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 [email protected].

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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to_:_ [email protected].