Sr. Director, Clinical Trial Optimization

Job Overview

Essential Duties and Responsibilities

• Define the vision, operating model, and phased roadmap for Clinical Trial Optimization, including which capabilities are built internally and how sponsor oversight of outsourced activities is applied.
• Build the capability across feasibility and enrollment planning and forecasting, protocol optimization, study start-up, and patient engagement and experience, sequencing the build to portfolio needs.
• Recruit, develop, and lead the team, operating hands-on while the function scales, and establish the processes, tools, data sources, and vendor strategy required to support it.
• Own feasibility and enrollment planning for the portfolio, ensuring enrollment, country, and site assumptions are evidence-based, risk-adjusted, and endorsed before studies advance through governance.
• Bring an operational lens to protocol design in partnership with Clinical Trial Management, Clinical Development and other cross enterprise functions, reducing complexity, patient and site burden, and avoidable amendments.
• Set the strategy for study start-up and site activation, partnering with Clinical Trial Management and Development Services to improve predictability and cycle time.
• Establish the approach to patient engagement and experience, integrating it into study design and feasibility, and oversee the vendors, digital channels, and advocacy partnerships that support it.
• Serve as the Clinical Operations business owner for the trial design, feasibility, and site activation solutions on Kardigan’s AI and digital transformation roadmap, partnering with Digital Health Innovation & AI Enablement on design, validation, and adoption.
• Define the performance measures for the function and use projected versus actual performance to continuously improve assumptions, models, and standards.
• Represent Clinical Trial Optimization with Clinical Operations, Development, and enterprise stakeholders in governance and stage-gate forums, and monitor industry and regulatory developments to inform strategy.
• Requires approximately up to 20% domestic and international travel.

Qualifications and Preferred Skills

• Bachelor’s degree in life sciences or a quantitative discipline; advanced degree (MS, MPH, MBA, PharmD, or PhD) preferred.
• 12+ years in pharmaceutical, biotechnology, or CRO global clinical development, including significant leadership in feasibility, trial optimization, study start-up, and/or patient recruitment.
• Demonstrated experience building a capability or team from the ground up and creating structure where none exists.
• Proven ability to challenge and validate CRO enrollment, start-up, and site assumptions in an outsourced or hybrid delivery model.
• Hands-on experience building enrollment forecasting models, feasibility tools, and operational benchmarks; fluency with industry data sources (e.g., Citeline, TriNetx, RWE data) and CTMS systems.
• Working understanding of predictive modeling, automation, and AI applications sufficient to define use cases and evaluate limitations.
• Strong knowledge of ICH-GCP, global regulatory requirements, and the country start-up landscape; cardiovascular or other competitively enrolling therapeutic area experience preferred.
• Exceptional communication and executive presence, translating complex analyses into decision-ready recommendations for senior leadership, and people leadership experience including hiring, performance management, and career development.

Leadership Competencies