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About the Role

The Associate Director of Epidemiology will provide strategic epidemiological leadership and operational execution across Jazz Pharmaceuticals' Global Research & Development organization, focusing primarily on oncology programs and supporting neurology development programs as needed. This role is responsible for the scientific design, leadership, and operational management of non-interventional pharmacoepidemiology studies and will spearhead the identification, synthesis, and communication of epidemiological evidence to support various strategic objectives.

Responsibilities

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).
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 to support portfolio forecasting, commercial strategy, due diligence, and pipeline prioritization.
Identify, evaluate, and access fit-for-purpose real-world data (RWD) assets globally (e.g., oncology-specific EMR networks, rare disease registries, administrative claims databases, genomic/biomarker databases, and prospective clinical cohorts).
Lead Requests for Proposals (RFPs), vendor evaluations, and Statement of Work (SOW) negotiations for external research partners, Contract Research Organizations (CROs), academic collaborators, and data vendors.
Manage external investigators, CROs, and scientific steering committees to ensure studies are executed on budget, on timeline, and to the highest standards of data integrity and regulatory compliance.
Guide and collaborate with biostatisticians and statistical programmers on analytical specifications, propensity score matching, immortal time bias mitigation, and other advanced epidemiological methods.
Champion external scientific dissemination by presenting research findings at key oncology and neurology congresses and authoring high-impact manuscripts for peer-reviewed journals.

Requirements

Minimum of 4+ years (for PhD) or 6+ years (for Master's) of 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, including navigating low-prevalence data limitations, case-finding algorithms, and natural history study designs.
Demonstrated track record of leading epidemiological research in oncology (solid tumors, hematologic malignancies, or rare cancer indications).
Proven expertise in non-interventional study designs, including retrospective/prospective cohorts, disease registries, and synthetic/external control arms (ECAs) using real-world data.
Direct experience working with complex longitudinal healthcare databases (e.g., EMR networks such as Flatiron, US Oncology, or Tempus; claims databases such as IQVIA, Optum, MarketScan; and disease-specific registries).
Demonstrated 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, with proven ability to translate complex epidemiological methods to non-technical stakeholders and regulatory reviewers.
Ability to work effectively in a hybrid/remote matrix environment.
Prior experience supporting neurology, neuro-oncology, or rare neurological conditions (e.g., rare epilepsies, movement disorders, neurodegenerative conditions).
Direct experience preparing and defending epidemiology-driven regulatory submissions before health authorities (FDA, EMA, MHRA, PMDA), particularly in support of accelerated approvals or orphan designations.
Experience with site-based data collection methods (e.g., multi-site retrospective medical chart reviews and hybrid registry studies).
Familiarity with post-marketing safety commitments, PASS/PAES protocols, and global pharmacovigilance regulations.

Skills

Epidemiology
Pharmacoepidemiology
Health Services Research
Oncology
Rare Disease Epidemiology
Natural History of Disease studies
External Control Arms (ECAs)
Post-marketing studies (PMRs/PMCs)
Risk Management Plans (RMPs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Real-world data (RWD)
Statistical Analysis Plans (SAPs)
Project Management
Matrix Leadership
SAS
R
Stata

Location

Remote

Work Type

Hybrid
Remote

Experience Level

Associate Director
4+ years (PhD)
6+ years (Master's)

Education Level

Advanced degree (PhD, ScD, DrPH, or MS/MPH) in Epidemiology, Pharmacoepidemiology, Health Services Research, or a closely related quantitative public health discipline.

Salary/Compensations

$156,000.00 - $234,000.00

Benefits

Medical insurance
Dental insurance
Vision insurance
401k retirement savings plan
Flexible paid vacation
Discretionary annual cash bonus or incentive compensation
Discretionary equity grants

About the Company

Jazz Pharmaceuticals is a global biopharma company dedicated to developing life-changing medicines for people with serious diseases, often with limited or no therapeutic options.
The company has a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Jazz's patient-focused and science-driven approach powers pioneering research and development advancements across its 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.
Visit www.jazzpharmaceuticals.com for more information.

Equal Opportunity

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.