Associate Director, Global Metabolic Nutrition Programs

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Company: Ultragenyx Pharmaceutical
Category: Management Occupations
Published on 2021-07-30 04:10:11

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Ultragenyx is looking for an experienced metabolic dietitian to provide strategic for regional launch and dietitian field activities and clinical trial support for our nutrition related programs, including our program for Long Chain Fatty Acid Oxidation Disorders (LC-FAOD). The Associate Director (AD), Global Metabolic Nutrition Programs, will be employed within the Global Medical Affairs group and report to the Senior Director, Global Metabolic Nutrition Programs. The AD will work with regional medical affairs teams to provide a clinically credible service is delivered to both internal scientific partners and external metabolic dietitians. The AD will lead the UX-007 program for LC-FAOD for Global Metabolic Nutrition Programs. We expect that, with time, a field team will be created reporting into this role. The AD will also work collaboratively across the matrix with relevant departments such as Clinical Science, Clinical Operations, Program Management, Manufacturing, Regulatory Affairs, Commercial Marketing, Market Access, and others. We ask that you have specific knowledge in the area of inborn errors of metabolism, nutrition, and the pharmaceutical industry.

Responsibilities including, but not limited to:

  • Maintain the production of the UX-007 Global Strategic Nutrition Program Plan
  • Work with the Medical Leads for UX-007, across all regions, to contribute to overall metabolic clinic, and specifically dietitian focused, launch strategies and field engagement planning
  • Contribute to overall LC-FAOD disease and product education strategy for dietitians, patients, and various HCPs
  • Identify metabolic dietitian Specialists (TLs) in LC-FAOD, and establish scientific relationships and collaborations
  • Maintain a high-level of scientific expertise on relevant nutrition aspects and assess existing relevant data gaps within our nutrition related programs
  • Provide scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports for nutrition related programs
  • Work with the Medical Director, Clinical Development to help develop essential 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, and to interpret, design, and communicate outputs for our nutrition related programs
  • Provide metabolic nutrition expertise on and insight for multiple work streams including Clinical Science, Clinical Operations, Program Management, Manufacturing, Regulatory Affairs, Commercial Marketing, Market Access, and others
  • Develop expert metabolic dietitian advisory boards related to topics of importance for our nutrition related programs, in collaboration with the Medical Leads for regions
  • Provide expert strategic guidance to relevant metabolic dietitian congress planning, publication planning, medical education activities, review of external investigator-initiated projects and collaborative research opportunities Provide fair balanced clinical presentations and medical information in response to unsolicited questions in academic, community, and healthcare provider settings
  • When requested, provide after hours field support to Medical Information to support clinicians managing individuals with LC-FAOD in crisis
  • Provide strategic advice to the Senior Director, Global Metabolic Nutrition Programs in the building of a future field team to support LC-FAOD
  • Contribute to the training, leadership and continuing education for Medical Affairs, Clinical, Commercial and Sales teams for both office-based and field-based employees
  • Participate in life cycle management projects regarding formula and alternative formulations for LC-FAOD
  • Requirements:

  • Registered Dietitian credentialing
  • Advanced degree in nutrition or related field
  • 5+ years of post-graduate clinical experience in inborn errors of metabolism/metabolic disorders is required
  • Pharmaceutical industry experience or equivalent
  • Experience managing a dietitian team
  • Project management
  • Establish problems, collect data, establish facts and draw valid conclusions
  • Familiarity with analyzing large, multivariate study datasets
  • Experience working with nutrition analysis tools such as MetabolicPro
  • Experience managing and working within cross-functional teams
  • Familiarity with GCP, ICH, FDA, EMA, NICE and other relevant guidelines
  • Experience in the composition, submission and publication of scientific literature
  • Ability to travel (for business meetings and field meetings at least 50% of the time)
  • #LI-REMOTE

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