Senior Director, Observational Research, CPSO

Overview

In this Senior Director role, you lead the Observational Research function within Clinical Program Strategy & Operations, shaping how real-world evidence is generated and delivered globally. You partner with Product Teams andCfOR to translate strategies into executable delivery models, ensuring quality, efficiency, and alignment with product objectives. You will establish the operating model, build capability, and drive continuous improvement across the Observational Research portfolio. This is a high-impact role at a mission-driven biotech company that values collaboration, innovation, and accountability.

Pay / Benefits

• comprehensive benefits package
• Retirement and Savings Plan with generous company contributions
• group medical, dental, and vision coverage
• life and disability insurance
• flexible spending accounts
• stock-based long-term incentives

Responsibilities

• Lead clinical operational strategy and execution for Observational Research across pragmatic trials and real-world evidence programs
• Translate evidence generation strategies into feasible delivery models
• Oversee portfolio planning, governance, and performance across Observational Research activities
• Contribute to KDEs, protocols, feasibility assessments, and study documentation
• Develop portfolio plans, timelines, resources, and budgets with Product Teams and Finance
• Manage risk, issue resolution, and implement corrective actions
• Standardize operational approaches to ensure consistency and quality
• Lead vendor strategy, governance, and performance for Real-World Evidence Clinical Operations
• Represent Observational Research in governance forums and cross-functional reviews
• Foster partnerships with CfOR and Regional Operations for global feasibility and execution
• Drive inspection readiness and CAPA implementation across the function
• Monitor enrollment strategy and delivery metrics; manage workforce planning and capability development
• Allocate resources and establish priorities and standardized practices
• Champion continuous improvement and scalable delivery models; assess new technologies and digital capabilities
• Promote an inclusive, collaborative, high-performing culture

Key requirements

• Doctorate degree and 5 years of clinical research/clinical operations/real-world evidence experience OR Master’s degree and 9 years OR Bachelor’s degree and 11 years
• Minimum 5 years of direct people management/global leadership experience leading teams or programs

• leadership
• collaboration
• strategic thinking
• observational research
• real-world evidence
• pragmatic clinical trials

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