Summary
Overview
Work History
Education
Skills
Timeline
Generic

Louis H. Le

Irvine

Summary

Professional project leader equipped with solid background in driving complex initiatives to successful completion. Strong emphasis on team collaboration, delivering impactful solutions, and adapting to shifting needs. Skilled in strategic planning, resource management, and stakeholder communication. Known for reliability and delivering measurable results.

Overview

17
17
years of professional experience

Work History

Project Director

ICON
05.2021 - 03.2025
  • Company Overview: Functional Service Provision (assigned to Johnson & Johnson CNS & Cardiovascular programs)
  • Developed and executed program-level operational strategies for complex, multi-phase clinical trials, ensuring alignment with the Clinical Development Plan (CDP) and business goals.
  • Led cross-functional teams across Delivery Units and Therapeutic Areas (TAs), achieving 100% on time delivery for key milestones in 5+ global studies.
  • Owned revenue and resource projections, managing budgets.
  • Identified and mitigated in unrecoverable costs through proactive risk management and contract modifications.
  • Ensured 95% budget adherence across all assigned projects.
  • Led scenario planning and risk mitigation strategies, resolving 20+ program-level risks impacting timelines and budgets.
  • Escalated critical issues to senior management, ensuring 100% resolution within agreed timelines.
  • Implemented risk-based monitoring (RBM) strategies that reduced monitoring costs.
  • Chaired 50+ client meetings, presenting program metrics, risks, and mitigation plans.
  • Successfully defended operational plans and costs at governance meetings.
  • Acted as the primary point of contact for program-level matters, ensuring cross-functional alignment and transparency.
  • Ensured 100% inspection readiness for 3+ programs, leading Health Authority inspections and developing risk mitigation plans for key issues.
  • Conducted readiness reviews and implemented corrective actions, resulting in zero critical findings during audits.
  • Onboarded and mentored 10+ new team members, fostering a culture of collaboration, inclusion, and Credo Behaviors.
  • Provided leadership and guidance to junior staff, enhancing team productivity and cohesiveness.
  • Streamlined clinical trial processes, reducing study start-up timelines by 20% and improving overall operational efficiency.
  • Oversaw 10+ vendor partnerships, ensuring compliance with contractual agreements and quality standards.
  • Functional Service Provision (assigned to Johnson & Johnson CNS & Cardiovascular programs)
  • Led the successful delivery of several studies, achieving First Patient Dosed (FPD) ahead of schedule and contributing to regulatory submissions.
  • Authored the Sponsorship Transition Playbook, streamlining IND transition processes for 3+ programs and ensuring seamless handover between companies.
  • Delivered several study Database Locks and CSR issuances, supporting regulatory submissions and approvals.
  • Optimized resource allocation and negotiated contract modifications.

Project Manager II

Syneos Health
03.2018 - 04.2021
  • Company Overview: formerly INC Research
  • Managed 10+ global, multi-protocol projects across Phase I-IV, ensuring 100% adherence to timelines, budgets, and quality standards.
  • Oversaw studies ranging from single-service to full-scope, multi-functional programs, delivering $20M+ in revenue annually.
  • Developed and implemented a COVID-19 management plan for a global study, reducing enrollment delays by 30% and ensuring patient safety.
  • This included remote monitoring strategies and virtual site visits, which maintained study integrity and data quality.
  • Developed and executed operational strategies for complex clinical trials, ensuring alignment with the Clinical Development Plan (CDP) and sponsor objectives.
  • Collaborated with cross-functional teams to optimize study designs, resulting in a 15% improvement in operational efficiency.
  • Formerly INC Research
  • Successfully delivered 5+ global studies on time and within budget, achieving 100% enrollment targets and 95% retention rates.
  • Improved study start-up timelines by 20%, resulting in faster trial initiation and reduced costs.
  • Optimized resource allocation and negotiated contract modifications, resulting in $1.5M+ in cost savings across projects.

Associate Director

Allergan Inc
01.2016 - 10.2017
  • Led and drove the clinical operations team for the assigned Global Central Nervous System, Ophthalmology studies/programs and ensured execution to support the successful regulatory registration of new products/indications.
  • Managed resources, training and program budgets.
  • Provided input to the operational strategy and into key documents e.g., study protocols and designs to ensure studies are operationally executable.
  • Ensure clear communication with senior management on operational updates.
  • Contributed to the operational development by providing input and leadership in processes and working practices so that a continuous clinical quality process improvement is within compliance.
  • Contributed to the successful regulatory registration of 2+ new products and indications, directly supporting Allergan’s pipeline growth.
  • Delivered 3+ global studies on time and within budget, achieving 100% enrollment targets and 95% retention rates.
  • Reduced study delays by 25% through proactive risk identification and resolution, ensuring timely delivery of critical milestones.
  • Optimized resource allocation and negotiated contract modifications, resulting in $15M+ in cost savings across programs.

Senior Clinical Study Manager

Allergan Inc
01.2012 - 12.2015
  • Accountable for study concept, planning and strategy phase execution for multiple protocols within Ophthalmology research.
  • Managed cross functionally in study initiation phase, enrollment, and close -out.
  • Assisted in completion of Clinical Study Reports.
  • Led talented team to achieve study goals with up to 6 direct reports.

Clinical Study Manager

Allergan Inc
01.2008 - 12.2011
  • Oversaw the study management of Ophthalmology research protocols.
  • Ensured study timelines and milestones are achieved within budget.
  • Ensured studies and cross-functional teams are audit inspection ready.
  • Managed Contract research organization to ensure successful partnership.

Education

Bachelor of Science - Biology

University of California, Irvine
Irvine, CA
06-1996

Skills

  • Project scope
  • Agreement negotiation
  • Scope development
  • Schedule management

Timeline

Project Director

ICON
05.2021 - 03.2025

Project Manager II

Syneos Health
03.2018 - 04.2021

Associate Director

Allergan Inc
01.2016 - 10.2017

Senior Clinical Study Manager

Allergan Inc
01.2012 - 12.2015

Clinical Study Manager

Allergan Inc
01.2008 - 12.2011

Bachelor of Science - Biology

University of California, Irvine

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Louis H. Le