Associate Director Real World Value & Evidence

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function:
Market Access

Job Sub Function:
Health Economics Outcomes Research

Job Category:
Professional

All Job Posting Locations:
Titusville, New Jersey, United States of America

The Associate Director, Real-World Evidence is responsible for leading real-world evidence activities in support of CAPLYTA and the assigned portfolio. This individual connects evidence-generation strategy with rigorous RWE study design, operational execution, data interpretation, and scientific dissemination. The Associate Director collaborates with internal and external clinical, RWE, epidemiology, analytics, safety, operations, and medical affairs experts to generate high-quality real-world evidence. The role is accountable for the quality of RWE study design, execution, interpretation, publication, and related models/tools developed for internal and external stakeholders.

This role also incorporates selected Clinical Project Scientist responsibilities where they strengthen RWE execution, including oversight of non-interventional research activities, post-marketing research programs, protocol development, study close-out activities, operational issue resolution, budget/contract coordination, and compliant cross-functional collaboration.

• Lead the design, implementation, and direct management of real-world evidence studies, non-interventional research activities, post-marketing research programs, and RWE-related models/tools from concept through publication.
• Formulate key RWE research questions, recommend fit-for-purpose methods, and ensure scientific rigor across retrospective and prospective data analyses, epidemiology, patient-reported outcomes, health services research, and other real-world data approaches.
• Develop and execute analytic plans using relevant healthcare data sources, including claims databases, electronic health records, registries, patient-level longitudinal datasets, and other real-world data sources, where appropriate.
• Provide active scientific and operational input to protocol development, RWE study design, amendments, study reports, clinical study reports, abstracts, manuscripts, congress presentations, and internal/external scientific communications.
• Oversee execution of RWE and research-related activities, including milestone tracking, study close-out, documentation, vendor training requirements, and operational readiness for audits.
• Support JJAR and ReCAP entries and close-out where relevant to RWE and Medical Affairs research activities.
• Collaborate with Clinical Operations, Medical Affairs, R&D, Epidemiology, Global Medical Safety, Regulatory Affairs, Quality Assurance, Health Care Compliance, Privacy, the Law Department, Strategic Operations, and external research partners to ensure timely and compliant study execution.
• Ensure adverse event data collection requirements for PSUR, PADER, and other annual regulatory obligations are incorporated into relevant research activities in partnership with Global Medical Safety and other safety personnel.
• Interpret RWE and clinical data to inform evidence-generation strategy, medical strategy, scientific narratives, publications, and data dissemination plans for CAPLYTA.
• Ensure projects are aligned with integrated evidence generation plans, business needs, and portfolio priorities, and that deliverables are completed on time and with scientific integrity.
• Develop and manage the RWE budget, support contract development, present plans to appropriate levels of management for approval, and manage budgeted funds appropriately.
• Ensure quality and compliance in internal and external communications related to RWE studies, protocols, reports, publications, training materials, models, tools, and other RWE outputs.

• Generate and report RWE using scientifically rigorous methods that can support evidence generation, publication planning, medical strategy, and stakeholder communication.
• Evaluate and apply appropriate methods for observational research, comparative effectiveness, pharmacoepidemiology, patient-reported outcomes, health services research, and real-world data analytics.
• Contribute to post-hoc analyses of clinical trial data and complementary RWE analyses to generate relevant outcomes information.
• Support interpretation of RWE outputs, including data tables, figures, study reports, abstracts, manuscripts, and congress presentations.
• Maintain high standards for data quality, scientific integrity, methodological…