Associate Director Epidemiology

Saved 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 to support portfolio forecasting, commercial strategy, due diligence, and pipeline prioritization.

3       Data Strategy & Operational Execution

·         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.

Required Knowledge, Skills, and Abilities

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

Industry Experience: 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.

Rare Disease Expertise: 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.

Oncology Experience: Demonstrated track record of leading epidemiological research in oncology (solid tumors, hematologic malignancies, or rare cancer indications).

Study Design & Methodologies: Proven expertise in non-interventional study designs, including retrospective/prospective cohorts, disease registries, and synthetic/external control arms (ECAs) using real-world data.

Secondary Data Acumen: 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).

Project Management & Matrix Leadership: Demonstrated ability to independently lead cross-functional study teams, manage external vendor performance and budgets, and balance multiple priorities across fast-paced development programs.

Communication: Exceptional written and verbal communication skills in English, with proven ability to translate complex epidemiological methods to non-technical stakeholders and regulatory reviewers.

Work Arrangement & Travel: Ability to work effectively in a hybrid/remote matrix environment, with availability to travel approximately 10% as needed.

Required/Preferred Education and Licenses

·         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).

·         Hands-on statistical programming proficiency (SAS, R, Stata) or familiarity with RWE analytical platforms (e.g., Aetion, Panalgo).

·         Familiarity with post-marketing safety commitments, PASS/PAES protocols, and global pharmacovigilance regulations.

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