Leonard Etuk MHA

Role Scope: Provide high-impact subject matter expertise on Phase 2/3 Asset Strategy and Study Start-Up (SSU) architecture for institutional investors and life science consultancies. Deliver strategic insights into clinical operations workflows to guide multi-million dollar investment due diligence. Asset Strategy & Due Diligence: Advise institutional investors on the operational viability and market competitiveness of Phase 2/3 clinical assets, identifying potential site-level bottlenecks before capital commitment. Strategic Outsourcing & FSP Models: Provide expert guidance on the evolution of FSP Models and delivery structures within the CRO/Biotech landscape to optimize clinical trial velocity. Operational Rescue Consulting: Leverage experience in Operational Rescue to consult on recovery blueprints for flagging clinical programs, ensuring alignment with FDA / EMA / MHRA Standards. Executive Stakeholder Relations: Act as a strategic bridge between clinical execution reality and investment strategy, translating complex operational metrics into actionable financial insights.

Role Scope: Lead operational architect for global clinical delivery, managing a $25M+ portfolio of mid-cap biotech programs across NA, Europe, and APAC. Responsible for Global Program Scaling and Resource Management (FTE Allocation) to ensure sponsor-centric delivery. FSP Models & Scaling: Built a 15-person Global Study Start-Up (SSU) division from the ground up, utilizing Strategic Outsourcing and FSP Models to provide scalable infrastructure for emerging biotech partners. P&L Management: Recovered $3.75M in under-leveraged assets by implementing rigorous Fiscal Stewardship and consolidating vendor services across the portfolio. Clinical Trial Management Systems (CTMS): Directed the integration of Cloudbyz CTMS, utilizing Data Integrity & Governance protocols to improve site activation predictability by 25%. Budget & Contract Negotiation: Launched the organization’s inaugural Site Contracts & Budgets department, slashing execution timelines by 40% through optimized Change Management and workflow redesign.

Role Scope: Engaged as a clinical operations specialist for a high-priority, eight-month mission to stabilize a global MASH (Hepatology) portfolio. Focused on Operational Rescue and Audit Mitigation for flagging Phase 2/3 assets. Risk-Based Monitoring (RBM/RBQM): Engineered a $1.2M fiscal rescue by transitioning the portfolio to a quality-first, Risk-Based Monitoring framework, reducing study spend by 23% in under 8 months. Vendor Governance: Mitigated critical audit risks and reduced non-conformities by 35% through aggressive Vendor Performance Management and the development of new SOP & QMS oversight models. Inspection Readiness: Prepared the global MASH portfolio for regulatory scrutiny, ensuring FDA / EMA / MHRA Standards were met ahead of pivotal data readouts.

Role Scope: Lead clinical representative for global Phase 3 programs; provided Matrix Management and Cross-functional Leadership for teams of 100+ members (CRAs, CTMs, and Data Management) to drive enrollment velocity and Submission Readiness. Risk-Based Monitoring (RBM/RBQM): Standardized a global RBM strategy for Pulmonary Arterial Hypertension (PAH) and Vaccine programs, maintaining 100% data quality while reducing monitoring costs by 25%. Analytics & Business Intelligence: Operationalized dashboard-driven submission readiness models that elevated TMF / eTMF Management quality metrics by 35%. Resource Management: Led matrix-level oversight for a 100+ member clinical team, improving personnel retention by 20% through strategic field-alignment and precise KPI & Metric Development. Global Delivery: Conducted targeted Accompanied Site Visits (ASVs) to secure Data Integrity & Governance and investigator relationships for critical global programs.

Role Scope: Strategic lead for global Phase 2/3 Hematology programs (MDS/Myelofibrosis). Directed Site Selection & Activation for 50+ global sites, ensuring alignment with IND / NDA / BLA Submission timelines. Database Lock & CSR: Directed assets through the full lifecycle to a successful Database Lock within 12 months, overseeing the finalization of Clinical Study Reports (CSR) for high-stakes Oncology submissions. ICH E6 (GCP) Compliance: Maintained a 100% quality record across 50+ sites, achieving zero critical non-conformities through rigorous adherence to Regulatory Compliance & Quality Assurance. Enrollment Optimization: Achieved a 95%+ patient retention rate by implementing a site-centric Risk-Mitigation Strategy that secured data integrity for complex multi-center trials.

Role Scope: Directed global monitoring operations and SSU strategy for massive-scale Phase 3 programs. Focused on Matrix Management and Cross-functional Leadership to harmonize global delivery teams. Global Study Start-Up (SSU): Directed the NA and LATAM SSU strategy for a flagship 10,000-subject Phase 3 program, utilizing predictive analytics to identify High-Velocity Sites and meet global launch timelines. Data Integrity: Improved clinical data integrity by 35% across Cardiovascular and Metabolic portfolios by operationalizing a high-velocity Quality Oversight Framework. Site Relationship Management: Spearheaded site identification and feasibility for Ophthalmology (nAMD) programs, selecting elite investigator hubs to maximize start-up velocity and Enrollment Optimization.

• Site Management Excellence: Executed all facets of site management—evaluation, initiation, routine monitoring, and close-out—ensuring rigorous adherence to protocols and GCP. • Quality & Compliance Execution: Conducted comprehensive source data verification (SDV) and maintained investigational product accountability, directly contributing to high-quality data collection and regulatory compliance. • Operational Efficiency: Prepared and submitted all monitoring visit reports (MVRs) on time, supporting transparent communication and efficient trial progression. • Site Identification & Feasibility: Played a key role in the site identification and feasibility process, evaluating and selecting potential investigators to ensure robust clinical trial placement and startup readiness.

• Site Management Excellence: Executed all facets of site management—evaluation, initiation, routine monitoring, and close-out—ensuring rigorous adherence to protocols and GCP. • Quality & Compliance Execution: Conducted comprehensive source data verification (SDV) and maintained investigational product accountability, directly contributing to high-quality data collection and regulatory compliance. • Operational Efficiency: Prepared and submitted all monitoring visit reports (MVRs) on time, supporting transparent communication and efficient trial progression. • Site Identification & Feasibility: Played a key role in the site identification and feasibility process, evaluating and selecting potential investigators to ensure robust clinical trial placement and startup readiness.