Director, R&D Data Science, Data Products - Global Development

Role Summary

Director, R&D Data Science, Data Products – Global Development. Lead strategy, design, and delivery of user-centric, reusable data products enabling analytics, data science, and AI/ML across Global Development. Ensure standardized, productized development data assets are integrated into the enterprise R&D data ecosystem, supporting trial efficiency, regulatory readiness, and compliance.

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 data products integrate into enterprise ontologies, knowledge graphs, and catalogs.
• Collaborate with Global Development stakeholders—including Clinical, Regulatory, Medical Writing, QA, and Safety—to co-create solutions that maximize value of development data assets.
• Interface with regulatory and compliance teams to ensure data products meet submission, disclosure, and transparency requirements.
• Lead a cross-functional team of product owners, data engineers, and Global Development domain experts.
• Establish governance models, agile delivery processes, and value-tracking metrics for Global Development data products.
• Define and track KPIs to measure impact on study startup times, operational insights, and regulatory compliance.
• Communicate product vision, roadmap, and value realization to Global Development leadership, Data Science teams, and executive stakeholders.
• Champion data literacy and adoption within the Global Development organization.
• Ensure Global Development data is transformed into trusted, AI-ready products that accelerate study startup, improve operational insights, and strengthen regulatory readiness.

Qualifications

• Education: 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 track record in data product development, integration, or semantic modeling in a regulated domain.
• Experience with multi-modal development data, including clinical trial, protocol, operational, submission, and disclosure datasets.

Skills

• 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 (CDISC, FHIR, ICH).
• Strong leadership, collaboration, and communication skills; ability to translate technical strategy into business/science value.
• Ability to influence stakeholders and drive adoption of new data capabilities across a complex organization.