Johnson and Johnson Innovative Medicine (J&J IM) needs to lead the strategy, design, and delivery of user-centric, reusable data products to enable advanced analytics, data science, and AI/ML solutions across the Global Development organization. This involves standardizing, productizing, and integrating high-value internal and external development data assets into the enterprise R&D data ecosystem to ensure AI-readiness, semantic consistency, and interoperability for improved trial efficiency, regulatory readiness, and compliance.
Requirements
- Strong track record in data product development, integration, or semantic modeling in a regulated domain.
- Experience working with multi-modal development data, including clinical trial, protocol, operational, submission, and disclosure datasets.
- Deep knowledge of Global Development processes, clinical trial design, and regulatory requirements.
- Deep knowledge of data products, database design, data transformation/mapping.
- Familiarity with metadata management, ontologies, knowledge graphs, and industry standards (e.g., CDISC, FHIR, ICH).
Responsibilities
- Lead a team to define and deliver data products addressing critical Global Development use cases (e.g., study startup, TMF metadata, operational KPIs, submission readiness).
- Define and maintain a roadmap for Global Development data products, spanning protocol development through clinical trial disclosure.
- Develop data products through agile delivery and FAIR data principles, ensuring scalability, interoperability, and reuse across Janssen functions and external partners.
- Integrate internal and external Global Development data sources, including CRO-provided datasets, performance benchmarks, and regulatory datasets.
- Contribute to the development and governance of a Global Development Ontology to enable semantic consistency across operational and regulatory domains.
- Align Global Development Ontology with enterprise metadata standards and external frameworks (e.g., CDISC, HL7 FHIR,etc).
- Partner with Knowledge Management, Data Product Architecture & Governance, and Master Data Management teams to ensure Global Development data products integrate seamlessly into enterprise ontologies, knowledge graphs, and catalogs.
Other
- PhD or Master’s in informatics, computer science, life sciences, or related discipline.
- 8+ years of experience in pharma/biotech R&D with focus on clinical development, operations, regulatory, or data product management.
- Strong leadership, collaboration, and communication skills, with ability to translate technical strategy into business/science value.
- Demonstrated ability to influence stakeholders and drive adoption of new data capabilities across a complex organization.
- This position requires up to 25% travel.
