Associate Director – Epidemiology

🕒 il y a 2 jours

🌐 États-Unis, Royaume-Uni – Distant

🇺🇸 États-Unis – Télétravail 🇬🇧 Royaume-Uni – Télétravail

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $156 000 - $234 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

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Jazz Pharmaceuticals

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1001 - 5000 employés

Fondée en 2003

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals est une entreprise biopharmaceutique dédiée au développement de médicaments innovants répondant à des besoins médicaux sérieux non satisfaits. Avec un fort engagement envers la recherche et le développement, Jazz se concentre sur la création de thérapies transformatrices, mettant en avant l'importance de la collaboration, de la diversité et de l'engagement des employés dans ses opérations. L'entreprise est fière de transformer la vie des patients grâce à ses offres de produits significatives et une culture qui favorise l'enthousiasme et la flexibilité.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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