Senior Manager, Epidemiology

Brief Description:

A Senior Manager (SM) of Epidemiology will support the epidemiological activities of Jazz’ Global Research & Development (R&D) organization. This role will be responsible for the scientific leadership and operational management of non-interventional pharmacoepidemiology studies, including studies designed to address Jazz’s post-marketing requirements/commitments (PMR/PMC) to regulatory authorities.  This role will also be responsible for identifying relevant epidemiology data for regulatory submissions and documents developed to support clinical development of investigational medicines in Jazz’ R&D portfolio, including Risk Management Plans (RMPs), Periodic Benefit-Risk Reports (PBRERs), orphan designation applications and others. The SM will report to the Senior Director of Epidemiology.

Essential Functions/Responsibilities

• Conduct/outsource literature searches to identify epidemiology data on disease incidence, prevalence, mortality, natural history, and cross-sectional studies describing the demographics, co-morbidities, treatment patterns and concomitant medications of the target patient populations in different geographies
• Contribute epidemiology data to regulatory submissions supporting Clinical Development Programs (e.g., RMPs, safety query responses, orphan drug applications, pediatric waivers, and external control arms) and other processes requiring epidemiological data
• Provide top of the patient funnel data for forecasting/commercial purposes
• Identify appropriate US and EU secondary data sources for studying the target patient populations (e.g., administrative claims and electronic medical records (EMR) databases)
• Lead Requests for Proposal (RFP) and Statement of Work for soliciting proposals and budgets from CROs and Data Providers for outsourced epidemiology studies
• Support a multi-disciplinary non-interventional Phase IV study team to deliver study-related regulatory submissions (e.g., protocols, statistical analysis plans, progress reports, interim study results and final study reports) in accordance with applicable regulatory guidelines and the PMR/PMC timetable set by a Health Authority
• Develop statistical analysis plans in collaboration with the project biostatistician (including those for analyses of administrative claims and EMR databases)
• Manage external investigators, project managers and operational leads at Contract Research Organizations (CROs) and/or Data Providers for outsourced studies to deliver high-quality results on time
• Communicate effectively with the US and EU Regulatory Leads on the timetable and status of all submission deliverables to fulfil a PMR/PMC
• Develop strong partnerships with internal stakeholders (e.g., Clinical Development, Medical Affairs, Biostatistics, Regulatory Affairs) to ensure that the appropriate epidemiological support is provided in their respective processes
• Communicate study plans, project timelines, budget projections, progress reports, interim and final study results to internal Jazz teams on time
• Present research findings at scientific congresses and co-author manuscripts for publication in peer-reviewed journals.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines

Required Knowledge, Skills, and Abilities

• Advanced degree (MS, MPH, MSPH, or PhD) in epidemiology or a related discipline (health services research, outcomes research, public health, pharmaceutical sciences)
• At least 2 years of experience in the pharmaceutical industry, CRO or in academia
• Experience with rare disease studies
• Project management experience in planning, budgeting, resourcing and executing the operational tasks required to complete a research study
• Experience successfully coordinating cross-functional processes
• Experience analyzing secondary data sources (administrative claims and EMR databases)
• Excellent oral and written communication skills in English
• Solid understanding of epidemiology and biostatistics
• Experience managing multiple projects and reprioritizing work when necessary
• Capable of working remotely with minimal supervision
• Proficiency with MS Word, Excel and PowerPoint
• Ability to travel approximately 10% time

Required/Preferred Education and Licenses

• Therapeutic area experience in oncology; strong knowledge of SEER data and use of SEER*Stat platform
• Experience with site-based data collection in non-interventional studies (prospective patient registries and retrospective chart reviews)
• Experience conducting post-marketing safety studies of marketed medicines
• Experience supporting Clinical Drug Development, Safety, Forecasting and Medical Affairs teams within a biopharmaceutical company 
• Experience authoring protocols, study reports, and epidemiology sections of RMPs for regulatory submissions to FDA, EMA and other health authorities
• Data analysis programming skills (SAS, Stata, R) or recent hands-on experience using an RWE platform technology 

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