Vice President, Neurology Global Clinical Development

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. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.

US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation. 

Roles based outside the US:  If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.

Position Summary

ultrainnovative – Tackle rare and dynamic challenges

Ultragenyx is looking for an experienced Vice President, Global Clinical Development, Neurology Therapeutic Area with the passion and creativity to develop great medicines for rare and ultra-rare diseases.

The ideal candidate is a physician with leadership experience of multiple global drug development programs and global filing experience who is enthusiastic about applying their knowledge to the cause of patients around the globe who have no approved therapies for their disease.

–         Rare diseases affect over 350 million people world-wide with only 400 therapies

–         Many are severe, chronic, and progressive, with high mortality rates

–         Most diseases have a profound impact on patients, their families, and society

The individual will be a self-starter 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 CMO and SVP, Global Clinical Development, Neurology Therapeutic Area, the individual will be responsible for the development and execution of multiple clinical research and post-commercial programs including the leadership of the pivotal trials, filing activities, and disease monitoring programs.

This position will serve as a key liaison between company and clinical investigators and establish credible relationships with opinion leaders, regulatory officials and other key stakeholders and partners.

The successful candidate will be ready for a career defining experience and have the passion to drive a number of therapeutics for serious debilitating diseases to final approval.

Work Model:

Flex: This is a Flex role, which 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.

Responsibilities:

• Direct involvement in trial design of Phase I/II/III/IV research trials and disease monitoring programs targeting rare or ultra-rare diseases with emphasis on CNS/Neurology diseases and Angelman’s Disease.
• Directly supervise and monitor trial conduct
• Work closely with all functions of the organization and external partners to manage trial logistics
• Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs.
• Identify opportunities for external collaboration
• 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
• Develop effective relationships with external providers
• Provide clinical assessments of potential in-licensing assets, identifying novel therapeutics opportunities as well as critical study design and execution challenges
• Review written materials and provide editorial comments for clinical study reports and manuscripts
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
• 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
• 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 as appropriate
• Provide medical surveillance on Serious Adverse Event (SAE) reporting, and follow-ups
• Direct and oversee the overall strategy for clinical drug product development and collaborating with Regulatory personnel in IND, CTA, and NDA submission activities as well as submission of IND safety reports
• Lead the clinical aspect of interactions with regulatory agencies worldwide
• Participate in the planning, writing, and review of Clinical Study Reports, regulatory updates, and submissions
• Assist with due diligence of new scientific developments
• Analyze and interpret study data for abstracts or publication as required
• Support corporate partnering efforts and business development activities by providing medical expertise and participating in partnership committees/task groups
• 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
• Plan and lead clinical focus groups to create clinical trial and protocol designs
• 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
• Lead the medical writing for the preparation of summarization of clinical trial data, including the preparation of study reports, integrated summaries, and clinical portions of package inserts and other product labeling

Requirements:

• M.D. or equivalent degree is required. Formal training in the areas of Genetics / Neurology is desired
• A minimum of 15+ years of clinical and managerial experience in drug development, ideally within rare disease or orphan indications
• Experience with trials though NDA / BLA
• Global clinical development experience required and global filing experience strongly preferred
• 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
• 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

#LM1

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 & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

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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: talentacquisition@ultragenyx.com.