Clinical Operations & Development

Director-level trial execution, built for speed and control.

I lead inspection-ready clinical trial operations and translate clinical strategy into measurable execution. Experienced across academic, VA, and industry-sponsored programs, with strong cross-functional leadership and rigorous governance.

Jean Mendez
Domains
Neuropsychiatry • Complex studies • Regulated environments
Strengths
Startup acceleration • Enrollment systems • Vendor governance
Operating Style
Decision gates • Clear ownership • High documentation quality

About

I am a physician by training and a clinical operations leader by practice. My work focuses on building scalable trial infrastructure, aligning stakeholders to the critical path, and delivering high-quality execution under real constraints—timelines, budgets, and regulatory complexity.

Trial Execution & Governance

End-to-end operational leadership from startup to closeout, with clear ownership, cadence, and escalation paths.

Regulatory & Inspection Readiness

GCP-aligned documentation, IRB workflows, delegation-of-authority rigor, and audit-ready trial master file practices.

Enrollment & Site Performance

Screening funnel optimization, site enablement, participant-centered burden reduction, and measurable performance gates.

Vendors, Budgets & Control

SOW/KPI management, vendor oversight, issue triage, and cost-to-complete discipline in resource-constrained environments.

Leadership & Impact

Startup
Reduced cycle time

Parallelized submissions; tightened vendor + regulatory workflows.

Execution
Stabilized complex dependencies

Resolved supply/regulatory bottlenecks and restored program momentum.

Infrastructure
Built scalable SOP/MOP stack

Standardized governance, documentation, and handoffs across studies.

Publications

Selected publications and research contributions.

View all

Contact

For roles in clinical operations / clinical development leadership, speaking requests, or collaborations, the fastest way to reach me is email or LinkedIn.