Associate Director – Epidemiology
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Job Description
Associate Director leading rare-disease and oncology epidemiology at global biopharma Jazz Pharmaceuticals. Designing real-world studies and supporting regulatory submissions across oncology and neurology.
Responsibilities:
- Provide strategic epidemiological leadership and operational execution across Global Research & Development
- Serve as epidemiology lead primarily across Oncology R&D programs, with support for Neurology programs as portfolio priorities dictate
- Lead multidisciplinary non-interventional study teams and deliver study concept sheets, protocols, statistical analysis plans, interim analyses, and final study reports
- Design and execute Natural History of Disease studies and external control arms
- Lead non-interventional post-marketing studies and deliver submission-ready study reports
- Partner with Clinical Development, GVHEOR, Real-World Evidence, Biostatistics, Regulatory Affairs, Medical Affairs, and Pharmacovigilance
- Author epidemiology and pharmacoepidemiology sections of global regulatory documents
- Communicate epidemiological data, study progress, risks, and timelines to US and EU Regulatory Leads and governance committees
- Provide incidence, prevalence, survival, and comorbidity estimates for forecasting, commercial strategy, due diligence, and pipeline prioritization
- Identify, evaluate, and access fit-for-purpose global real-world data assets
- Lead RFPs, vendor evaluations, and SOW negotiations
- Manage external investigators, CROs, and scientific steering committees to ensure studies meet budget, timeline, data integrity, and compliance standards
- Guide biostatisticians and statistical programmers on analytical specifications and advanced epidemiological methods
- Present research findings at oncology and neurology congresses and author peer-reviewed manuscripts
Requirements:
- Advanced degree (PhD, ScD, DrPH, or MS/MPH) in Epidemiology, Pharmacoepidemiology, Health Services Research, or a closely related quantitative public health discipline
- Minimum of 4+ years of relevant experience for PhD or 6+ years for Master's
- Relevant experience in the pharmaceutical/biotechnology industry, an academic research center, or an epidemiology/RWE-focused CRO
- Proven, hands-on experience designing and executing epidemiological studies in rare diseases
- Demonstrated track record of leading epidemiological research in oncology
- Proven expertise in non-interventional study designs, including retrospective/prospective cohorts, disease registries, and synthetic/external control arms using real-world data
- Direct experience working with complex longitudinal healthcare databases
- Demonstrated ability to independently lead cross-functional study teams, manage external vendor performance and budgets, and balance multiple priorities
- Exceptional written and verbal communication skills in English
- Ability to work effectively in a hybrid/remote matrix environment, with availability to travel approximately 10% as needed
- Prior experience supporting neurology, neuro-oncology, or rare neurological conditions
- Direct experience preparing and defending epidemiology-driven regulatory submissions before FDA, EMA, MHRA, or PMDA
- Experience with site-based data collection methods
- Hands-on statistical programming proficiency in SAS, R, or Stata, or familiarity with RWE analytical platforms such as Aetion or Panalgo
- Familiarity with post-marketing safety commitments, PASS/PAES protocols, and global pharmacovigilance regulations
Benefits:
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
- Remote work arrangement
- Hybrid/remote matrix environment
- Travel approximately 10% as needed
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