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

Role Overview

• 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
• 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
• 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

Requirements

• 10+ years in product management or complex digital solution development with knowledge in product or 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
• 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: ability to elicit, analyze, and synthesize requirements from senior leadership, translate complex statistical concepts into business language and vice versa, manage conflicting priorities and negotiate strategic trade-offs
• Superior business analysis and quantitative problem solving: ability to develop sophisticated statistical models, perform advanced data analysis, develop comprehensive business cases with complex ROI calculations, and drive data-based decision making at enterprise scale
• Demonstrated ability to think and influence strategically: ability to connect products to organizational goals and quantifiable impact, drive change management and adoption of technical solutions, challenge assumptions with data-driven insights, and build trust with executive stakeholders
• Bachelor's required, Master's or PhD degree highly preferred in a relevant field
• Additional business or technical certifications (PMP, Agile, etc.) valued.

Tech Stack

• PMP

Benefits

• high-quality healthcare
• prevention and wellness programs
• at least 14 weeks’ gender-neutral parental leave