Senior Director of Clinical Trial Optimization

Socket.dev; Princeton (NJ); On-site; USD 242,000 - 315,000; Full time

Job summary

Kardigan is seeking a Senior Director, Clinical Trial Optimization to establish and lead a new internal capability spanning feasibility, enrollment forecasting, protocol optimization, site activation, and patient engagement. This leader will set the operating model within Clinical Operations and partner across functions to ensure evidence-based decisions before studies advance.

The role requires building a team, scaling capabilities, and owning AI-enabled trial design initiatives with

Qualifications

• Bachelor’s degree in life sciences or quantitative discipline; advanced degree preferred.
• 12+ years in pharma/biotech/CRO with leadership in feasibility, trial optimization, start-up, or patient recruitment.
• Experience building a team and validating CRO enrollment/start-up assumptions.
• Hands-on experience with enrollment forecasting tools and operational benchmarks.
• Fluency with industry data sources and CTMS systems; AI awareness advantageous.
• Strong communication and executive presence; cardiovascular trial exposure preferred.

Responsibilities

• Define vision, operating model, and phased roadmap for Clinical Trial Optimization.
• Build capacity across feasibility, enrollment planning, protocol optimization, and site activation.
• Recruit, develop, and lead the team; establish processes, data sources, and vendor strategy.
• Own feasibility and enrollment planning; ensure evidence-based, risk-adjusted assumptions.
• Collaborate on protocol design to reduce complexity and site burden; improve cycle time.
• Set strategy for study start-up and site activation; partner to improve predictability.
• Oversee patient engagement/experience and related vendors and digital channels.
• Act as Clinical Operations business owner for trial design and activation on AI roadmap.
• Define metrics and drive continuous improvement; report in governance forums.
• Travel up to 20% domestically and internationally.

Skills

Leadership

Feasibility planning

Enrollment forecasting

Protocol optimization

Study start-up

Patient engagement

Cross-functional collaboration

Executive communication

CRO/vendor management

AI & data enablement familiarity

Education

Bachelor’s degree in life sciences or quantitative discipline

MS/ MPH/ MBA/ PharmD/ PhD preferred

Tools

CTMS systems

Citeline

TriNetx

RWE data sources

Job description

Kardigan is seeking a Senior Director, Clinical Trial Optimization to establish and lead a new internal capability spanning feasibility, enrollment forecasting, protocol optimization, site activation, and patient engagement. This leader will set the operating model within Clinical Operations and partner across functions to ensure evidence-based decisions before studies advance.

The role requires building a team, scaling capabilities, and owning AI-enabled trial design initiatives with