Senior Director, Global Epidemiology

Ultragenyx Pharmaceutical

3h•Remote

About The Position

ultrafocused – Work together to fearlessly uncover new possibilities This key position will represent Global Epidemiology across functional teams for translational research, business development, pipeline and commercialized programs. The Senior Director Global Epidemiology is responsible for epidemiology strategy and leadership among cross-functional project teams including leadership for epidemiology across the portfolio of Ultragenyx programs globally. Generate epidemiology data to support clinical development and regulatory filings. This includes design, implementation and data analysis of epidemiological studies. Provide consultation as an internal subject matter authority in epidemiology to other departments. Research activities can include generation and analysis of evidence around incidence, prevalence, morbidity and mortality, as well as partnership across all relevant initiatives across Ultragenyx disease areas. They will be responsible for collaboratively leading the discussion and implementation of modern and innovative epidemiological approaches to help evaluate the efficacy, safety and ultimately help inform the benefit-risk profile of a drug based on data from different sources. This global role will lead epidemiological assessments using existing bodies of evidence and generating data where they do not exist. They will assist with any relevant epidemiological and outcomes research, statistical analysis plans, and analysis output as requested across programs.

Requirements

BA/BS in the Life Sciences, Public Health, Epidemiology or Health Economics AND MA/MS in the Life Sciences, Public Health, Epidemiology, Health Economics or Pharmacy;
12 + years of relevant experience in biopharmaceutical industry, with epidemiology
clinical background/research experience preferred
Excellent interpersonal and organizational skills with the ability to work well in a multidisciplinary team and across the matrix. Key stakeholders include Medical Strategy, Clinical Development, Global DSPV, Molecular Diagnostics, Biostatistics, GHEOR, Global and Regional Commercial, Business Development, Translational research
Experience in epidemiological research activities including study design, data management and analysis, with experience in analysis of large data assets, de novo evidence generation, input into clinical trial design & analysis and evidence- based synthesis from literature
Effective communication of epidemiological strategy and findings, both written and verbal, is required.
Self-motivated with the ability to work independently, to develop credibility with colleagues, and to influence decisions with excellent interpersonal and organizational skills with the ability to work well in a multidisciplinary team and across the matrix.
Strong technical expertise in epidemiology principles, and knowledge of analytical applications, demonstrating a sophisticated understanding of, and the ability to interpret, quantitative methods is required, with a working knowledge of statistical analysis software (SAS, STATA, R)
Experience in strategic planning and project management, with proficiency in working cross-cultural/global teams

Nice To Haves

Prefer advanced degree in the life sciences (PharmD, PhD, MD)
Rare Disease and Global experience preferred

Responsibilities

Identified as an Epidemiology subject matter expert, able to provide consultation as an internal epidemiology subject matter authority to other departments and responsible for developing epidemiology strategy and leadership among cross-functional project teams, to mitigate risk and achieve success, across the portfolio of Ultragenyx programs globally
Identify evidence gaps to inform strategic planning and lead development of new evidence strategies to increase understanding of target patient populations of UGX programs and lead development of new evidence generation strategies to achieve market access across global target patient populations of UGX programs
Lead development of new evidence strategies to increase understanding of target patient populations of UGX programs, including robust epidemiologic indicators such as incidence and prevalence of disease, disease risk factors and morbidity & mortality. Assessing patient populations for new program opportunities via business development and helping to craft our external communications.
Provide relevant input into clinical development plans, integrated evidence generation plans, regulatory documents with accuracy and scientific integrity, generate content and direction for business development proposals on projects
Proactively partners across UGX to collaborate and demonstrate cross-functional leadership across the organization to facilitate alignment around key epidemiologic indicators, building partnerships with drug safety and pharmacovigilance facilitate
Identifies & leads cross functional teams for external collaborative observational research partnerships from project inception thru publication(s) and presentation(s)
Provide leadership through influencing without authority across project teams, internally and externally, can identify & lead cross functional teams for external collaborative research partnerships from project inception thru publication(s) and presentation(s)
Represent Ultragenyx as Global Epidemiology subject matter expert at external professional, scientific meetings and forums