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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.
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:- 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
- 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;
- Prefer advanced degree in the life sciences (PharmD, PhD, MD)
- 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
- Rare Disease and Global experience preferred
- Travel: approximate 10-25%
#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.
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 [email protected].
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.
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