Director of Real-World Evidence and Implementation Science Research

🔥 3 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Cardiovascular Associates of America - CVAUSA

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Cardiovascular Associates of America - CVAUSA is headquartered in Orlando and seeks to unify leading cardiovascular physicians under one network dedicated to enhancing patient care, reducing costs, and saving lives. The organization emphasizes clinical innovation and operates on a physician-centered practice management model that empowers doctors to lead clinical care and cultivate their practice culture while utilizing shared resources and business expertise.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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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