Director - Clinical Design Modeling and Simulation Product Owner - Digital RnD

Main Responsibilities
Strategic Leadership
- Define and execute product roadmaps aligned with enterprise-level business objectives and quantitative success metrics
- Develop and implement long-term strategic vision for AI and statistical modeling applications in clinical development
Technical Direction
- Provide expert guidance on statistical modeling, machine learning approaches, and agentic AI implementation
- Collaborate with biostatistics teams to evaluate emerging technologies and methodologies for potential application in clinical design
- Ensure proper validation and documentation of modeling approaches
Stakeholder Management
- 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
Qualifications
- 10+ years in product management or complex digital solution development with knowledge in product/software-oriented roles 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 and their application in drug development
- Excellent stakeholder management and executive communication
- Superior business analysis and quantitative problem solving (ROI/business cases, enterprise-scale data-based decisions)
- Ability to think and influence strategically (connect products to organizational goals, drive adoption, challenge assumptions with data)
Education
- Bachelor’s required; Master’s or PhD highly preferred in a relevant field
- PMP/Agile and other business/technical certifications valued