Director - Clinical Design Modeling and Simulation Product Owner - Digital RnD
Sanofi
14 hours ago
Remote friendly (Cambridge, MA)
United States
$161,250 - $232,916.66 USD yearly
Clinical Research and Development
Main Responsibilities
- Define and execute product roadmaps aligned with enterprise business objectives and quantitative success metrics
- Develop and implement long-term strategic vision for AI and statistical modeling applications in clinical development
- Provide expert guidance on statistical modeling, machine learning approaches, and agentic AI implementation
- Collaborate with biostatistics teams to evaluate emerging technologies and methodologies for application in clinical design
- Ensure proper validation and documentation of modeling approaches
- Partner with executive leadership across Digital Data Science, Translational Medicine, Development teams, and Clinical Operations to drive product adoption
- Present complex quantitative findings and product strategies to senior leadership
- Negotiate resource allocation and strategic priorities with key stakeholders
- Build strategic partnerships with external vendors and academic institutions
Experience / Qualifications
- 10+ years in product management or complex digital solution development with knowledge of building AI/data products with statistical components
- Healthcare/biotech experience with clinical datasets (highly preferred)
- Experience with regulatory submissions and compliance for AI/ML applications (preferred)
Skills
- Expert knowledge of statistical modeling, machine learning algorithms, and AI applications in clinical development
- Familiarity with PTRS modeling and simulation techniques for clinical trial optimization
- Advanced understanding of biostatistical methods in drug development
- Excellent stakeholder management and executive communication
- Strong business analysis and quantitative problem solving; ability to build models and ROI cases and drive data-based decisions
- Strategic thinking and ability to drive change/adoption using data-driven insights
Education
- Bachelor’s required; Master’s or PhD highly preferred in a relevant field
- PMP/Agile or other business/technical certifications valued
- Define and execute product roadmaps aligned with enterprise business objectives and quantitative success metrics
- Develop and implement long-term strategic vision for AI and statistical modeling applications in clinical development
- Provide expert guidance on statistical modeling, machine learning approaches, and agentic AI implementation
- Collaborate with biostatistics teams to evaluate emerging technologies and methodologies for application in clinical design
- Ensure proper validation and documentation of modeling approaches
- Partner with executive leadership across Digital Data Science, Translational Medicine, Development teams, and Clinical Operations to drive product adoption
- Present complex quantitative findings and product strategies to senior leadership
- Negotiate resource allocation and strategic priorities with key stakeholders
- Build strategic partnerships with external vendors and academic institutions
Experience / Qualifications
- 10+ years in product management or complex digital solution development with knowledge of building AI/data products with statistical components
- Healthcare/biotech experience with clinical datasets (highly preferred)
- Experience with regulatory submissions and compliance for AI/ML applications (preferred)
Skills
- Expert knowledge of statistical modeling, machine learning algorithms, and AI applications in clinical development
- Familiarity with PTRS modeling and simulation techniques for clinical trial optimization
- Advanced understanding of biostatistical methods in drug development
- Excellent stakeholder management and executive communication
- Strong business analysis and quantitative problem solving; ability to build models and ROI cases and drive data-based decisions
- Strategic thinking and ability to drive change/adoption using data-driven insights
Education
- Bachelor’s required; Master’s or PhD highly preferred in a relevant field
- PMP/Agile or other business/technical certifications valued