Executive Director, Head of Global Site Management
Kardigan · Princeton, NJ · 1 wk ago
Business DevelopmentFull-time
Key Responsibilities
- Build & lead global site management, monitoring, and study start-up activities across all clinical programs
- Develop and execute site strategies to optimize selection, activation, enrollment, and retention
- Establish consistent monitoring models, including risk-based monitoring approaches
- Build and maintain strategic relationships with investigative sites, site networks, and partners
- Partner closely with Clinical Operations, Clinical Development, Biometrics, and Development Services to ensure seamless, disciplined program and trial execution
- Identify and mitigate site-level operational and quality risks
- Create and continuously improve standard operating procedures, work instructions, to ensure inspection readiness
- Participate in regulatory authority inspections, sponsor audits, and oversee site audits in partnership with Quality
- Ensure compliance with GCP, regulatory requirements, and internal standards
- Ability to assess and transform capabilities through AI and Automation solutions or strategies
- Up to 20-30% domestic and international travel, as required.
Qualifications
- Bachelor's degree in life sciences or related field
- 12+ years of experience in site management or clinical operations leadership
- Or advanced degree (PhD, MBA, Masters) and 10+ yrs of experience
- Deep expertise in global study start-up and enrollment optimization
- Strong people leadership and stakeholder management skills