Sr. Director, Clinical Trial Optimization

Kardigan•Princeton, NJ

1d•$242,000 - $315,000•Hybrid

About The Position

Kardigan is seeking an experienced Senior Director, Clinical Trial Optimization to establish and lead a new internal capability spanning feasibility and enrollment planning and forecasting, protocol optimization, study start-up, and patient engagement and experience. Sitting within the Global Site Management pillar of Clinical Operations, this leader will define the operating model, build the team, and ensure enrollment, country, and site assumptions are evidence-based, risk-adjusted, and operationally sound before a study advances through governance. This is the first role of its kind at Kardigan. The successful candidate will set functional strategy while personally delivering early portfolio work, scaling the team in phases as the pipeline grows. Partnering with Digital Health Innovation & AI Enablement, Clinical Trial Management, Clinical Development, Medical Affairs, Development Services, and other enterprise stakeholders, this leader will also serve as a Clinical Operations business owner for the trial design, feasibility, and site activation solutions on Kardigan’s AI and digital transformation roadmap.

Requirements

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.

Nice To Haves

cardiovascular or other competitively enrolling therapeutic area experience preferred.

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.