Associate Director Epidemiology

Jazz Pharmaceuticals

7d•$156,000 - $234,000

About The Position

The Associate Director of Epidemiology provides strategic epidemiological leadership and operational execution across Jazz Pharmaceuticals' Global Research & Development organization. The role primarily supports oncology programs, including rare hematology and solid tumors, and provides cross-functional support to neurology development programs as needed. The position reports to the Senior Director of Epidemiology. The role leads the scientific design and operational management of non-interventional pharmacoepidemiology studies, including natural history of disease studies, external control arms, post-marketing requirements and commitments, and disease registries. It also identifies, synthesizes, and communicates epidemiological evidence for clinical development, orphan drug designations, regulatory submissions, commercial forecasting, and global health authority interactions. The Associate Director partners with clinical, health economics and outcomes research, real-world evidence, biostatistics, regulatory, medical affairs, and pharmacovigilance teams. The role identifies and accesses global real-world data sources, manages external research partners and study execution, guides epidemiological analyses, and disseminates findings through congress presentations and peer-reviewed publications. The work arrangement may be hybrid or remote, with approximately 10% travel as needed.

Requirements

Advanced degree (PhD, ScD, DrPH, or MS/MPH) in Epidemiology, Pharmacoepidemiology, Health Services Research, or a closely related quantitative public health discipline.
At least 4 years of relevant industry, academic research center, or epidemiology/RWE-focused CRO experience for PhD holders, or at least 6 years for master's degree holders.
Hands-on experience designing and executing epidemiological studies in rare diseases, including addressing low-prevalence data limitations, case-finding algorithms, and natural history study designs.
Demonstrated track record of leading epidemiological research in oncology, including solid tumors, hematologic malignancies, or rare cancer indications.
Expertise in non-interventional study designs, including retrospective and prospective cohorts, disease registries, and synthetic or external control arms using real-world data.
Direct experience with complex longitudinal healthcare databases, such as EMR networks, claims databases, and disease-specific registries.
Ability to independently lead cross-functional study teams, manage external vendor performance and budgets, and balance multiple priorities across fast-paced development programs.
Exceptional written and verbal communication skills in English and ability to explain complex epidemiological methods to non-technical stakeholders and regulatory reviewers.
Ability to work effectively in a hybrid or remote matrix environment and travel approximately 10% as needed.

Nice To Haves

Experience supporting neurology, neuro-oncology, or rare neurological conditions, such as rare epilepsies, movement disorders, or neurodegenerative conditions.
Direct experience preparing and defending epidemiology-driven regulatory submissions before health authorities, particularly for accelerated approvals or orphan designations.
Experience with site-based data collection methods, such as multisite retrospective medical chart reviews and hybrid registry studies.
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.

Responsibilities

Serve as the epidemiology lead primarily across Oncology R&D programs, with capacity to support 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 in accordance with international guidelines and regulatory commitments.
Design and execute natural history of disease studies and external control arms to contextualize single-arm trials and support clinical development in rare oncology and neurology indications.
Lead non-interventional post-marketing studies and deliver submission-ready reports within health authority timetables.
Partner with Clinical Development, GVHEOR, Real-World Evidence, Biostatistics, Regulatory Affairs, Medical Affairs, and Pharmacovigilance to support methodologically sound integrated evidence generation plans aligned with strategic brand objectives.
Author epidemiology and pharmacoepidemiology sections of regulatory documents, including orphan drug designation applications, pediatric study plans, risk management plans, periodic benefit-risk evaluation reports, and health authority briefing books and information requests.
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 portfolio forecasting, commercial strategy, due diligence, and pipeline prioritization.
Identify, evaluate, and access fit-for-purpose global real-world data assets, including oncology EMR networks, rare disease registries, administrative claims databases, genomic and biomarker databases, and prospective clinical cohorts.
Lead requests for proposals, vendor evaluations, and statement-of-work negotiations for external research partners, CROs, academic collaborators, and data vendors.
Manage external investigators, CROs, and scientific steering committees to ensure studies are completed on budget and on time and meet data integrity and regulatory compliance standards.
Guide and collaborate with biostatisticians and statistical programmers on analytical specifications and methods such as propensity score matching and immortal time bias mitigation.
Present research findings at oncology and neurology congresses and author manuscripts for peer-reviewed journals.