Role Summary
Director, R&D Data Science โ Patient Mastering, Consent & Preference Management. Leads strategy, governance, and operationalization of patient-centric master data across R&D, ensuring patient, consent, and preference data are accurate, complete, traceable, and accessible to enable trusted data use in clinical development, real-world evidence generation, and regulatory submissions. Reports to the R&D Data Science & Digital Health โ Data Strategy & Products team and develops best-in-class approaches for patient mastering and consent management.
Responsibilities
- Patient Master Data Strategy & Execution: Lead design and delivery of a forward-looking patient mastering strategy for high-quality data across R&D; develop and maintain a unified patient master connecting patient, account, and clinical study data for interoperability.
- Consent & Preference Management: Establish frameworks and tools for capturing, managing, and tracking patient consent and preferences; ensure alignment with privacy regulations and ethical standards.
- Data Quality & Stewardship: Drive data stewardship across platforms and vendor ecosystems; define data quality metrics and SLAs for patient and consent data with partners and stakeholders.
- Governance & Compliance: Partner with Legal, Privacy, and Compliance to ensure governance; drive adoption of standards (CDISC, HL7 FHIR, GDPR consent models) and ontologies.
- Collaboration & Integration: Work with Data Product Architecture, Knowledge Management, and Data Product teams; engage Clinical Development, Safety, Regulatory, Medical Writing, and partners to align on data definitions, access, and usage.
- Strategic Communication & Leadership: Advocate for trusted patient data; provide leadership updates on data quality, consent compliance, and adoption; build and mentor a team of data stewards and domain experts.
- Strategic Impact: Enable ethical, compliant, scalable reuse of patient data across R&D; support analytics, AI-driven insights, and regulatory readiness.
Qualifications
- Education: Bachelorโs or masterโs in Information Management, Data Science, Health Informatics, Computer Science, or related; Masterโs preferred.
- Experience: 15+ years in data management/governance or clinical data in pharma/biotech; 10+ years delivering MDM capabilities in pharma; deep understanding of MDM and patient data domains; expertise in consent and preference management; regulatory knowledge (GDPR, HIPAA, 21 CFR Part 11); standards knowledge (CDISC, HL7 FHIR, OMOP, GA4GH).
- Leadership: Strong leadership, stakeholder engagement, change management, and communication skills; ability to partner across R&D, IT, Regulatory, and external data providers.
- Other: Travel < 25%.
Skills
- Advanced Analytics, Data Privacy, Data Quality, Data Governance, Data Management
- MDM, Consent & Preference Management, Regulatory Compliance
- Leadership, Stakeholder Engagement, Program Management, Strategic Thinking