Global Head of Clinical Data and Business Strategy
Sanofi
15 days ago
Remote friendly (Morristown, NJ)
United States
$232,500 - $335,833.33 USD yearly
Clinical Research and Development
Main Responsibilities
- Lead Clinical Data Technology: partner with clinical development teams for seamless data flow; drive AI-powered clinical data processing strategy; enable real-time access to diversified clinical data; define and execute AI roadmap for clinical data flows; establish governance for validation, change management, quality assurance, and regulatory compliance; standardize clinical database design aligned with CDISC (SDTM/ADaM/CDASH).
- Expand diversified patient data sources: partner with Procurement/Digital/Vendor Excellence on technology, CRO, and academic partnerships; enable real-time eHR and patient-generated data (wearables/mobile health); integrate innovative data collection methodologies; ensure interoperability across traditional and novel sources.
- Business strategy leadership: define and execute clinical data business strategy and sourcing; represent CDAIP in enterprise digital transformation; drive thought leadership; maintain relationships with regulatory agencies/industry consortia/external partners.
- Team & stakeholder management: lead, mentor, and develop teams; align goals with company strategy; integrate AI/data processing into existing workflows with cross-functional partners.
Qualifications
- Advanced degree (MS/PhD) in Life Sciences, Computer Science, Data Science, Biostatistics, or related; or Bachelor’s with extensive leadership experience.
- 10+ years progressive leadership in clinical development/data management/biostatistics/AI in pharma/healthcare.
- Expertise in clinical data management/analytics across the lifecycle.
- Strong knowledge of clinical database design, data management planning, and CDISC (SDTM, ADaM, CDASH).
- Deep understanding of clinical trial processes, regulatory requirements (FDA/EMA/ICH-GCP), and data governance.
- Proven transformational leadership; strong communication and stakeholder influence.
Benefits (if selected)
- Health and wellbeing benefits, including healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Lead Clinical Data Technology: partner with clinical development teams for seamless data flow; drive AI-powered clinical data processing strategy; enable real-time access to diversified clinical data; define and execute AI roadmap for clinical data flows; establish governance for validation, change management, quality assurance, and regulatory compliance; standardize clinical database design aligned with CDISC (SDTM/ADaM/CDASH).
- Expand diversified patient data sources: partner with Procurement/Digital/Vendor Excellence on technology, CRO, and academic partnerships; enable real-time eHR and patient-generated data (wearables/mobile health); integrate innovative data collection methodologies; ensure interoperability across traditional and novel sources.
- Business strategy leadership: define and execute clinical data business strategy and sourcing; represent CDAIP in enterprise digital transformation; drive thought leadership; maintain relationships with regulatory agencies/industry consortia/external partners.
- Team & stakeholder management: lead, mentor, and develop teams; align goals with company strategy; integrate AI/data processing into existing workflows with cross-functional partners.
Qualifications
- Advanced degree (MS/PhD) in Life Sciences, Computer Science, Data Science, Biostatistics, or related; or Bachelor’s with extensive leadership experience.
- 10+ years progressive leadership in clinical development/data management/biostatistics/AI in pharma/healthcare.
- Expertise in clinical data management/analytics across the lifecycle.
- Strong knowledge of clinical database design, data management planning, and CDISC (SDTM, ADaM, CDASH).
- Deep understanding of clinical trial processes, regulatory requirements (FDA/EMA/ICH-GCP), and data governance.
- Proven transformational leadership; strong communication and stakeholder influence.
Benefits (if selected)
- Health and wellbeing benefits, including healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.