Debbie Johnson

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Debbie Johnson

Executive Clinical Operations Consultant

Debbie
Johnson

Bringing Therapies From Bench to Bedside

With over two decades of hands-on experience navigating the complexities of global clinical trials, Debbie Johnson partners with pharmaceutical companies, CROs, and investigative sites to deliver Phase 1 through Phase 3 programs — on time, on budget, and inspection-ready.

20+
Years Experience
Phase 3
Trial Expertise
Global
CRO & Site Network
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Phase III CRO Sites FDA EMA ICH GCP

“Precision, partnership, and purpose — from protocol to approval.”

Core Competencies

Deep Expertise Across
the Clinical Trial Lifecycle

From protocol design through regulatory submission, Debbie brings executive-level oversight and operational precision at every stage.

Clinical Trial Design & Strategy

Protocol development, study design optimization, and strategic planning for Phase 1–3 trials across multiple therapeutic areas and geographies.

CRO Oversight & Management

Full lifecycle CRO selection, contracting, oversight, and performance management to ensure delivery against scope, budget, and timelines.

Global Site Operations

Site identification, qualification, initiation, and performance management across the US, EU, Asia-Pacific, and emerging markets.

Regulatory & GCP Compliance

FDA, EMA, and ICH GCP compliance guidance, audit readiness, inspection preparation, and CAPA management for global programs.

Data Integrity & Risk Management

Centralized monitoring strategies, risk-based approaches to clinical quality, and data integrity frameworks to protect trial integrity.

Team Leadership & Mentoring

Building and leading high-performance clinical operations teams, fractional executive support, and mentoring rising clinical professionals.

About Debbie

20+ Years Moving
Therapies Forward

Debbie Johnson is an executive-level clinical operations consultant who has spent more than two decades embedded in the operational realities of bringing new drugs to patients. Her career spans roles within pharmaceutical sponsors, global CROs, and investigative site networks — giving her a uniquely holistic perspective.

She has served as a trusted partner to biotech startups and large-cap pharma alike, providing strategic oversight and hands-on operational leadership for late-stage programs navigating the most complex regulatory environments worldwide.

Phase 1 – Phase 3 Trial Leadership Full lifecycle execution across oncology, CNS, cardiovascular, rare disease, and immunology
CRO Partnership Expertise Deep relationships and oversight experience with top-tier global CROs
Regulatory Inspection Readiness FDA, EMA, PMDA, and national competent authority inspection support
Global Operations Programs executed across North America, Europe, Asia-Pacific, and Latin America
20+
Years of Clinical Operations Experience
"I've sat across from regulators, held the hand of struggling sites, and kept programs on track when the stakes could not have been higher. What I bring is experience earned — not theory."
Phase III CRO Management FDA / EMA ICH E6 R2 Risk-Based Monitoring eTMF EDC IXRS

What I Offer

Consulting Services

Flexible engagement models designed to meet your program where it is — from strategic advisory to embedded operational leadership.

Fractional VP / Head of Ops →
CRO Selection & Oversight →
Regulatory & Inspection Readiness →
Site & Patient Recruitment Strategy →
Program Rescue & Recovery →
Advisory & Strategic Consulting →

Fractional VP / Head of Clinical Operations

Biotech and specialty pharma companies often need executive-caliber clinical operations leadership without the cost of a full-time hire. Debbie steps in as your embedded Fractional VP or Head of Operations — owning the function, driving accountability, and building the infrastructure for sustainable growth.

  • Full operational ownership of clinical programs and CRO relationships
  • Vendor governance, budget management, and timeline stewardship
  • Building and managing in-house clinical ops teams
  • Representing operations to boards, investors, and regulatory bodies
  • Flexible engagement: part-time, full-time, or project-based

CRO Selection & Oversight

Selecting the right CRO partner is one of the most consequential decisions in any clinical program. Debbie leverages her deep industry relationships and evaluation expertise to guide sponsor teams through RFP processes, selection, contracting, and ongoing governance.

  • CRO capability assessment and RFP development
  • Proposal evaluation, bid defense facilitation, and selection support
  • Contract and budget negotiation guidance
  • Governance framework design and KPI establishment
  • Oversight audit and performance course-correction

Regulatory & Inspection Readiness

Regulatory inspections demand meticulous preparation. Debbie provides comprehensive readiness assessments, mock inspection support, and CAPA management to ensure your team and TMF are inspection-ready at all times.

  • FDA, EMA, PMDA, and NCA inspection preparation
  • Mock inspection conduct and debrief
  • eTMF gap assessment and remediation planning
  • GCP compliance audits at sites and CROs
  • CAPA development and follow-through monitoring

Site & Patient Recruitment Strategy

Enrollment challenges derail more clinical programs than almost any other factor. Debbie brings a data-driven, site-centric approach to recruitment planning that gets patients into studies and keeps them there.

  • Feasibility study design and country/site selection
  • Site identification, qualification, and activation
  • Enrollment forecasting and scenario modeling
  • Recruitment enhancement and retention strategy
  • Site performance management and escalation

Program Rescue & Recovery

When a clinical program is off-track — whether due to enrollment challenges, CRO performance issues, data quality concerns, or operational breakdown — Debbie brings a calm, experienced hand to diagnose root causes and implement rapid recovery plans.

  • Rapid operational assessment and root cause analysis
  • Remediation roadmap development and prioritization
  • CRO transition management and knowledge transfer
  • Stakeholder communication and crisis management
  • Recovery tracking and milestone restoration

Advisory & Strategic Consulting

From due diligence support for investors to pipeline readiness assessments for leadership teams, Debbie provides clear-eyed strategic counsel grounded in real-world operational expertise.

  • Clinical operations due diligence for M&A and investment
  • Pipeline and portfolio operational readiness review
  • Clinical operations SOPs and process development
  • Executive coaching for clinical operations leaders
  • Board and investor presentation preparation

Worldwide Presence

Global Reach,
Local Knowledge

Clinical programs don't stop at borders. Debbie has operational experience across every major clinical trial region in the world.

20+
Years Experience
Phase 3
Trial Capability
40+
Countries
Multi
Therapeutic Areas
United States European Union United Kingdom Canada Japan South Korea Australia Brazil Mexico South Africa India Israel

Get in Touch

Let's Discuss Your
Program

Whether you're looking for embedded executive leadership, CRO oversight support, or strategic guidance, Debbie is available for an introductory conversation to explore how she can best support your goals.

[email protected]
linkedin.com/in/debbie-s-johnson
Available upon request

Available For Fractional engagements · Project-based consulting · Advisory board participation · Expert witness services · Speaking engagements