Associate Director Real World Value & Evidence

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

1d•$137,000 - $235,750•Hybrid

About The Position

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.

Requirements

Minimum Master’s degree in Public Health, Health Services Research, Economics, Epidemiology, Pharmacy, Health Policy, Biostatistics, Mathematics, Health Administration, Operations Research, Neuroscience, or a related discipline required.
Minimum 5 years of relevant experience in real-world evidence, epidemiology, public health, pharmaceutical industry, payer, insurer, health system, medical affairs, clinical research, or related setting.
Experience designing and conducting RWE, patient-reported outcomes, retrospective/prospective data analyses, pharmacoepidemiology, post-marketing research, non-interventional studies, or health services research studies.
Experience translating evidence-generation strategies into actionable RWE tactics, study concepts, protocols, analytic plans, publications, and dissemination materials.
Experience with protocol development, interpretation of results, and preparation of scientific communications for internal and external audiences.
Knowledge of clinical research operations, study documentation, vendor oversight, budget/contract coordination, and compliant study execution.
Working knowledge of drug development, regulatory approval processes, safety reporting considerations, and regulatory/commercial compliance considerations related to research and dissemination of scientific information.
Strong collaboration, influencing, written communication, presentation, and medical writing skills, including experience with publications, posters, abstracts, or manuscripts.
Ability to operate in a matrixed environment, partner with cross-functional alliances, balance multiple priorities, and develop solutions with strong ethical judgment.
Knowledge of medical terminologies such as ICD, NDC, SNOMED, MedDRA, LOINC, and CPT.

Nice To Haves

Doctorate or other advanced degree preferred.

Responsibilities

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 transparency, and compliant dissemination of RWE.

Benefits

Annual performance bonus
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year (varies by state)
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year