Associate Director Epidemiology at Jazz Pharmaceuticals in Home-Based, PA

Job description

If you are a current Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Job Description The Associate Director (AD) of Epidemiology will provide strategic epidemiological leadership and operational execution across Jazz Pharmaceuticals' Global Research & Development (R&D) organization. This role will primarily focus on oncology programs (including rare hematology and solid tumors), while providing agile, cross-functional support to neurology development programs as needed. The AD will be responsible for the scientific design, leadership, and operational management of non-interventional pharmacoepidemiology studies, including Natural History of Disease studies (NHS), external control arms (ECAs), post-marketing requirements/commitments (PMR/PMC), and disease registries. Additionally, the role will spearhead the identification, synthesis, and communication of relevant epidemiological evidence to support clinical development, orphan drug designations, regulatory submissions (e.g., Risk Management Plans, Periodic Benefit-Risk Evaluation Reports), commercial forecasting, and health authority interactions globally. Given the focus on niche indications and unmet medical needs, demonstrated expertise in rare disease epidemiology is required. The AD will report to the Senior Director of Epidemiology. Essential Functions/Responsibilities 1 Strategic Evidence Generation & Study Leadership · Serve as the epidemiology lead primarily across Oncology R&D programs, with dynamic capacity to support Neurology programs as portfolio priorities dictate. · Lead multi-disciplinary non-interventional study teams to deliver study concept sheets, protocols, statistical analysis plans (SAPs), interim analyses, and final study reports in accordance with international guidelines (GPP, ENCePP) and regulatory commitments. · Design and execute robust Natural History of Disease (NHS) studies and external control arms (ECAs) to contextualize single-arm trials and accelerate clinical development in rare oncology and neurology indications. · Lead non-interventional post-marketing studies (PMRs/PMCs) and deliver submission-ready study reports within strict health authority timetables (e.g., FDA, EMA, PMDA). 2 Cross-Functional Collaboration & Regulatory Support · Partner closely with Clinical Development, Global Value & Health Economics and Outcomes Research (GVHEOR), Real-World Evidence, Biostatistics, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to ensure integrated evidence generation plans (IEGP) are methodologically sound and aligned with strategic brand objectives. · Author epidemiology and pharmacoepidemiology sections of global regulatory documents, including Orphan Drug Designation (ODD) applications, Pediatric Study Plans (iPSP/PIP), Risk Management Plans (RMPs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and health authority briefing books/information requests. · Communicate epidemiological data, study progress, risks, and timelines effectively to US and EU Regulatory Leads and governance committees. · Provide robust incidence, prevalence, survival, and comorbidity estimates