Medical Director, Global Clinical Development, Neurology

Ultragenyx Pharmaceutical Inc.; United States; Remote; USD 259,000 - 320,000; Full time

Job summary

A leading biotechnology company is seeking a Medical Director for Global Clinical Development in Neurology. This remote position requires a physician-scientist with expertise in clinical development and neuroscience. The role involves medical monitoring, study design, and collaboration with regulatory agencies to advance treatments for rare diseases.

Benefits

Generous vacation time

Long term incentive and Employee stock purchase plans

Fitness reimbursement

Qualifications

• Experience in clinical development and translational research.
• Trained in GCP regulations, familiar with ICH and FDA guidelines.

Responsibilities

• Perform medical monitoring for ongoing clinical trials.
• Provide medical and scientific input in review of clinical data.
• Support study execution and author early clinical development plans.

Skills

Leadership

Collaboration

Communication

Curiosity

Education

MD or MD/PhD

Job description

Medical Director, Global Clinical Development, Neurology

United States - Remote

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 andpersonally, come join our team.

Position Summary:

ultraimpact – Make a difference for those who need it most

Ultragenyx is a leading fully integrated biotechnology company in rare disease development. We are seeking a physician-scientist with experience in clinical development to be a member of the expanding Neurology Therapeutic Area. This individual will have clinical neurology or pediatrics with neuroscience training with expertise in early clinical development and translational research. They will be curious and collaborative, creative and resourceful in addressing clinical, scientific and operational challenges for ongoing clinical studies and new INDs. This individual will conduct medical monitoring and participate in interpretation of clinical data for our late stage Angelman’s Syndrome program and contribute to study design and strategy for INDs entering clinical studies. This position will provide clinical development representation at team and regulatory interactions and responsible for establishing long-lasting relationships with key thought leaders, study investigators, CRO partners, and patient organizations.

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:

• Perform medical monitoring for ongoing clinical trial(s)
• 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.
• Support study execution, including review and cleaning of study data, updating study protocols, reviewing consent forms and other patient-facing materials, reviewing electronic case report forms, reviewing periodic safety reports, and training study sites
• Formulate clinical responses to regulatory, institutional review board (IRB) and ethics committee (EC) inquiries
• Formulate first-in-human concepts and study protocol design and present to corporate governance for approval
• Author early clinical development plans and present to corporate governance for approval
• Exhibit leadership skills within and outside of the organization (including people skills, mentoring, presentation skills and professional interaction). Inspire a cross-functional team to promote high performance and keep team members focused on the highest priority activities for study
• Critical review and scientific contribution to clinical study reports and manuscripts
• Work with the clinical operations and finance teams to assist with the production of budgets and timelines for clinical trials.
• Participate in pre-submission, pre-market and other meetings with the FDA and other regulatory agencies, as needed

Requirements:

• MD or MD/PhD
• Originally boarded in neurology (peds or adult) or pediatrics with clear record of neuroscience research
• Academic scientific research in a related field
• Prefer 2-3 years of industry experience or leadership of industry-sponsored clinical trials
• Trained in GCP regulations, familiar with ICH and FDA guidelines relevant to clinical development
• Experience designing successful clinical studies in complex diseases requiring the management of patient variation, chronic irreversible disease and related complexities.
• Facile with statistical issues to collaborate with a statistician to design the analysis of clinical studies
• Travel to study sites, team meetings, scientific conferences, and patient organization meetings approximately 1-2 times per quarter
• Ability to integrate and interpret complex clinical data and present them succinctly and clearly to an audience
• Actively listen to and value others’ thoughts and ideas. Demonstrate effective partnership both within and outside your team. Achieve results with and through others.
• Demonstrate self-awareness, humility, and curiosity in service of self-development. Provide regular coaching and feedback that will inspire growth and improvement in others. #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

$259,100 - $320,000 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

· Long term incentive and Employee stock purchase plans or equivalent offerings

· Fitness reimbursement

* 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 [e-mail] .

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:[e-mail] .

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