Director, Clinical Outcomes Research and Evaluation at Ultragenyx in Woburn, MA

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:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Endpoint Development & Strategy (CORE) will be responsible for the conduct of outcomes research that investigates the impact of rare diseases to informs the design of clinical trials. They will also provide data-driven recommendations to prioritize endpoint selection, development and validation activities to establish the efficacy of investigational products. Additional responsibilities include leveraging current trends in outcomes research and clinical efficacy reporting to support communications with regulatory authorities, the medical community, patient associations and payers.

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.

Responsibilities:

Develop and validate disease-specific outcome measures, including functional, observational, clinician-reported and patient-reported outcome measures for use as clinical efficacy endpoints in clinical trials.
Design clinical trials that characterize the burden and the impact of investigational products on the primary clinical signs and symptoms of rare diseases.
Prepare and review research protocols, statistical analysis plans, clinical study reports and regulatory submission documents.
Conduct gap analyses through consultation with disease experts, patient associations, outcomes researchers and health economists.
Collaborate with cross-functional groups to create a patient-focused clinical and economic value proposition to support product approval, labeling, prescribing patterns and reimbursement.
Support presentation and publication of clinical outcomes research to contribute to the field and achieve product-specific objectives.
Manage vendors engaged to develop and validate disease-specific measures and conduct site training to standardize efficacy data collection.

Requirements:

Minimum of a Master’s degree in a scientific discipline (outcomes research, health services research, epidemiology, public health, or related fields)
Minimum of 7 years work experience in clinical development. Experience with rare disease and pediatric clinical research preferred.
Strong working knowledge of the drug development process.
Experience researching and summarizing complex scientific information.
Effective written and oral communication skills.
Ability to manage projects across programs and prioritize as required.
Able to work effectively in a multidisciplinary team environment.

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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