Vice President, Global Clinical Development, Neurology

Remote

Why Join Us?

Be a hero for our rare disease patients

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:

ultradedicated – Your biggest challenges yield rare possibilities

Ultragenyx is looking for a Head of Neurology Therapeutic Area, Vice President of Global Clinical Development. The ideal candidate is a physician-scientist with leadership experience in global drug development specifically in rare disorders, with experience and training in neurology, pediatrics and genetics. The individual will lead a neurology portfolio with several clinical programs, and support early clinical collaborations with Translational Research. We are seeking a critical thinker, able to integrate genetics and mechanistic understanding to the strategic implementation of clinical development plans in the neurology therapeutic area. Reporting to the Senior Vice President of Global Clinical Development, the individual will be responsible for the management, development and execution of multiple clinical research and post-commercial programs. This is an active leadership role, with key visibility to internal and external stakeholders, including regulatory officials, thought leaders, key investigators and study sites.

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:

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

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
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 #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

$371,000—$458,300 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].

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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].

Ultragenyx Pharmaceutical

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.

Website LinkedIn

View all jobs

Salary

$371,000 – $458,300 per year