Senior Dietitian, Clinical Sciences
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position will be located in Novato, CA.
The Senior Clinical Science Dietitian (Sr. CSD) will work within the Clinical Science group and report to the Vice President, Global Clinical Development to support one or more clinical metabolic-genetic programs.
The Sr. CSD may serve in various roles, not limited to membership on clinical trial teams and project sub-teams.
The Sr. CSD will provide technical and strategic input for the planning and tactical execution of the clinical development plan by working collaboratively with colleagues in relevant functions such as Clinical Science, Clinical Operations, Clinical Outcomes Research and Evaluation (CORE) Biometrics, Program Management, Medical Affairs, Research and Development, and Pharmacovigilance.
Responsibilities, including but not limited to:
- Develop and lead the execution of the Strategic Dietary Program Plan for the assigned product(s)
- Develop and lead the execution of the Dietary Data Review Plan and Dietitian Engagement Field Plans for the assigned product(s)
- Manage one or more field-based Ultragenyx study dietitians
- Maintain high-level of scientific expertise on relevant dietary aspects within the assigned disease area(s)
- Provide scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports.
- Work with Medical Director to assist in the development of key documents to support the components of trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books and Pediatric plans).
- Partner with BioMetrics and others to identify analyses of interests, as well as to interpret, design, and communicate outputs.
- Attend and contribute to relevant scientific conferences, seminars or presentations.
- Registered Dietitian Degree, metabolic dietician experience preferred
- Minimum 5+ years of post-graduate clinical experience, pharmaceutical industry experience or equivalent
- Experience in rare genetic disease preferred
- Ability to think creatively and efficiently to define problems, collect data, establish facts and draw valid conclusions
- Familiarity with reviewing and analyzing large, multivariate study datasets
- Experience working with dietary analysis tools such as MetabolicPro
- Experience managing and working within cross-functional teams
- Familiarity with GCP, ICH, FDA, EMEA, NICE and other relevant guidelines.
- Experience in the composition, submission and publication of scientific literature
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.