Director of Real-World Evidence and Implementation Science Research

🕒 Outubro 29

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Cardiovascular Associates of America - CVAUSA

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2021

🏥 Saúde

⚕️ Seguro de Saúde

💊 Farmacêutico

Healthcare • Healthcare Insurance • Pharmaceuticals

Sediada em Orlando, a Cardiovascular Associates of America tem como objetivo reunir os melhores médicos cardiovasculares em uma rede com a missão comum de salvar vidas, reduzir custos e melhorar o atendimento ao paciente por meio de inovação clínica. Através do modelo de gestão de práticas centrado no médico da CVAUSA, os médicos conduzem o cuidado clínico e a cultura de suas práticas, enquanto se beneficiam da expertise empresarial e dos recursos compartilhados disponíveis através da CVAUSA.

Descrição

• Develop and lead CVAUSA’s program of observational and pragmatic research using clinical, imaging, and administrative claims data • Forge partnerships with research sponsors and develop CVAUSA’s RWE and implementation science research portfolio • Oversee the design of RWE studies to ensure methodological soundness and alignment with cardiovascular science, research, quality, and clinical care objectives • Develop the strategic vision, roadmap, growth targets, business case, operating model, and resourcing plan for the RWE and observational research service line • Lead end-to-end execution of RWE engagements, observational studies, registries, and investigator-initiated research • Establish scalable processes, standard operating procedures, and quality controls • Translate clinical and business questions into research concepts, objectives, endpoints, populations, and methodologies • Develop research protocols for prospective and retrospective observational studies, registries, chart reviews, and database studies • Lead feasibility assessments and develop study-specific operational plans • Oversee study start-up, including protocol finalization, budgets, contracting, IRB submission, data-use requirements, site readiness, training, and study launch • Prepare and oversee IRB and research compliance submissions • Establish data access, data-use agreements, privacy protections, governance requirements, and security controls • Oversee study conduct, data collection, issue resolution, protocol deviations, quality review, and closeout • Coordinate biostatistics, epidemiology, data science, clinical, and external partner resources • Support abstracts, manuscripts, presentations, sponsor reports, and other scientific outputs • Manage external vendors, contracts, statements of work, budgets, timelines, and deliverables • Support business development, sponsor outreach, pipeline management, proposals, capabilities materials, pricing, contracting, and revenue tracking • Serve as day-to-day leader for the RWE and observational research service line, accountable for operations, quality, and results • Build and manage a cross-functional team and foster relationships with clinicians, practices, and internal stakeholders

🎯 Requisitos

• Master’s degree in a relevant field (health sciences, epidemiology, public health, life sciences, data science, business, or related) with demonstrated experience developing research programs • 10+ years of experience in real-world evidence, observational/epidemiologic research, health outcomes research, clinical research operations, or a closely related field, including experience leading studies or programs end to end • Experience independently developing and operationalizing research studies, including protocol development and writing, study feasibility and resource assessment, IRB/regulatory submission, study start-up and activation, research conduct, and study closeout • Strong working knowledge of real-world data sources (EHR, claims, registry, and clinical data) • Familiarity with methodological and regulatory considerations governing RWE • Demonstrated program or project management skills, with a track record of delivering complex initiatives on time and on budget • Experience managing external vendors, partners, or consultants, including contracting and budget oversight • Strong commercial acumen and comfort supporting business development, proposals, and sponsor relationships • Excellent written and verbal communication skills, including ability to translate between scientific, operational, and commercial audiences • Terminal degree PhD, PharmD, or equivalent strongly preferred • Experience in cardiovascular medicine, cardiology, or a related therapeutic area preferred • Familiarity with AI/ML-enabled research platforms and their application to real-world data preferred • Experience working with pharmaceutical, medical device, or diagnostics sponsors on RWE or observational studies preferred • Prior experience securing and managing multi-year contracts and grants preferred • Has managed a research program P&L of at least $10M preferred • Understanding of IRB processes, HIPAA, data governance, and Good Clinical Practice standards preferred • Experience in a physician practice, health system, or research network environment preferred

🏖️ Benefícios

• Opportunity to build a real-world evidence capability from the ground up at a national scale • Work closely with and learn from physician, research, and quality leaders • Direct impact on how evidence is generated and used to improve patient care • Mission-focused organization dedicated to excellence in cardiovascular care and clinical research

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