Stephani V. Wilford, BS, MBA, PMP

Experience

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  Bausch & Lomb

  Mar 1993 - Nov 1996

  Scientist I
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  Schering-Plough Research Institute

  Dec 1997 - Jun 1999

  Clinical Research Associate
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  AbbVie (formerly Solvay Pharmaceuticals, Inc)

  Jun 1999 - Jan 2011

  Global Program Manager / Clinical Research Associate / Sr. Clinical Research Associate

  Led global study management team and the successful completion of clinical trials, in accordance with all county/state/federal and GCPs regulations, ICH guidelines, and internal SOPs for the 6th largest biomedical company, serving 170+ countries; 50K staff, generating $58.05B annual revenues. Planned, organized, and implemented all operational activities related to setup, study conduct, documentation, and reporting of Neuroscience, Infectious Disease, Gastroenterology, and Men’s & Women’s Health clinical trials. Oversaw study timelines vs. program strategic plans; communicated project status to Therapeutic Area Directors and stakeholders on project timelines and known risks. Managed internal/external clinical operational activities; adhered to scope of work requirements. Reviewed study protocols, case report forms, and informed consent forms with Data Management, Statistics, and Clinical Study support teams. Collaborated with Clinical Supplies Manager to forecast/maintain adequate clinical supplies.Selected Achievements:☑Facilitated preparation and collection of site and country-level documents.☑Key Stakeholder Manager; liaised directly with pharmaceutical company and clinical investigator sites to resolve issues and optimize site relationship. ☑Global Program Manager, Phase IIb Clinical Study for Advanced Parkinson’s disease (54 patients); Duopa submitted and approved by FDA.☑Pioneer Award recipient; Phase II/III IBS Clinical Study. Tilansetron application submitted to FDA for approval (2002). Show less

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  Fortrea

  May 2011 - Sept 2023

  Ensured global delivery for site activation across multiple therapeutic areas and study phases. Managedend-to-end site readiness process, site identification and selection, EC/IRB submission, risk identification and mitigation, financial management, audit readiness, regulatory compliance, and timeline management. Supervised 3 Startup Global Project Managers and controlled $35M budget. Global clinical trials included Phase III Symptomatic Obstructive Hypertrophic Cardiomyopathy (170 patients) and Acute Myeloid Leukemia Phases I/II. Portfolio lead over partnership clients; served as Global Site Director for site readiness. Oversaw Startup Project Managers and Regulatory Submission Leads to ensure adherence to overall project timelines for regulatory/ethics submission and site activation targets. Performed risk strategy assessments of newly awarded studies to identify/resolve risks and meet budgetary guidelines. Provided input on proposals and project strategies; participated in bid defense meetings to develop new business opportunities. Lead internal Project Review meetings to monitor site activations, project risk/mitigation strategies, and contingency plans. Submitted monthly project updates to senior leadership stakeholders regarding risk, enrollment metrics, and project financials. Selected Achievements:☑Executed successful Site Readiness CTIS submission of Symptomatic Obstructive Hypertrophic Cardiomyopathy, Phase III study to meet new regulatory requirements for European Union. Built strong relationship with client during process; improved reports/presentation, instilled trust, and delivered project on time.☑Nimble Operating Model “Blended Role.” Created and implemented training to establish dual clinical and project management roles for Delivery. ☑DEI, Representative. Ensured compliance with FDA-mandated diversity requirements for studies (2022). ☑Consistently retained employment and promoted throughout Covance, LabCorp, and Fortrea mergers. Show less Led project teams and managed operational, clinical, and financial risk across all therapeutic areas. Conducted meetings with Project Managers, Startup Managers, and cross-functional support teams to analyze, identify, and mitigate risk for all clinical trials. Collaborated with Project Management Office (PMO) to identify/develop process improvements, to include operational, quality, risk, and financial management processes, based on performance data. Facilitated effective internal cross-functional collaboration with various study teams to achieve enterprise solutions. Selected Achievements:☑Chosen as Startup SME and Portfolio Governance Global Representative for Biotech and BioPharma issues during monthly leadership meetings. ☑Developed and implemented Risk-Based Quality Metrics to assess overall health of client portfolios; collaborated with internal data teams to collect, collate, and integrate data from 300-500 clinical trials to interpret trends. Submitted/presented reports to Project Centricity Executive Leadership teams.☑Established Delivery SOPs to improve financial performance and risk identification/mitigation.☑Evaluated Quality SOPs and Project Governance Reviews. Created Integrated Quality Risk Management Plan to resolve risk management deficiencies following all internal/external audits. ☑Selected for Career Progression Program, 1st rotation Governance and 2nd rotation Site Readiness Dept. Show less Coordinated and managed 4 global clinical trials, from pre-award through study closeout; indirect oversight of 15 Functional Leads. Directed day-to-day technical, financial, operational, and delivery aspects of all assigned clinical projects; strictly adhered to contractual requirements, financial performances, and ICH/GCPs regulations. Collaborated with Functional Leads to identify and resolve fundamental issues and accurately interpret data; ensured all project deliverables met Key Performance Indicators (KPIs) and time/quality/cost expectations. Participated in performance initiatives to improve processes and/or implement new initiatives/systems to enhance quality delivery. Facilitated communication between client, functional team, and stakeholders; managed and revised variances to required project plans, as needed. Defined and managed project resources; established succession plans for key resources.Selected Achievements:☑Selected for Career Progression Program; offered 2-year Portfolio Governance role to expand operational knowledge and cross-functional experience. ☑Met database and recruitment timelines for all projects.☑Facilitated employee career progression; developed 4 staff for eventual promotion.☑Recipient, bonus increases and numerous Covance Ace and Cultural Belief Awards for Site Readiness, Customer Service, and On Time Readiness. ☑During tenure at Covance/, always exceeded expectations during performance reviews as Sr. PM and Project Director in project delivery. Show less Managed clinical operations, quality results, and served as key client liaison for global clinical trials, from study inception to completion. Studies included GALNS: Morquio A Syndrome, Phase III (recruitment); Type II Diabetes, Phase II/III; Cardiovascular Outcomes, Phase IV; and Chronic Kidney Disease and Hyperuricemia, Phase (recruitment). Monitored project schedule, identified/mitigated risks, adhered to study budget, managed client project metrics, and submitted monthly status reports to senior leadership and stakeholders. Proactively engaged in Quality Assurance and Risk Management audits; ensured timely project delivery, financial target attainment, and audit/regulatory inspection readiness. Led core global team meetings; facilitated cross-functional collaboration among project team members and ancillary services. Represented Project Management team in bid-defense meetings for new contracts.Selected Achievements:☑Diabetes II clinical trial for Steglatro; global Phase III study with 1,250 patients across 25 countries.Submitted to FDA and received approval (April 2014-May 2016).☑ Chronic Kidney Disease and Hyperuricemia, global Phase IIb clinical trial for Verinurad; 861 patients, 12 countries. Created effective tracking system to meet 750 enrollment requirements during COVID.environment. Submitted application to FDA and received approval (July 2019-June 2020).☑Partnered with Project Management team to rescue a global Phase III pediatric clinical trial for GALNS: Morquio A Syndrome. Led cross-functional collaboration to meet recruitment and timeline deadlines; subsequently awarded additional clinical studies (2011-2017).☑Recipient, Covance Ace and Cultural Belief Awards. Show less

  • Project Director, Site Readiness/Startup Management: Remote Employee

    Oct 2022 - Sept 2023

  • Associate Director, Portfolio Governance

    Nov 2020 - Oct 2022

  • Project Director

    May 2019 - Nov 2020

  • Sr. Project Manager

    May 2011 - May 2019
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  ICON plc

  May 2024 - now

  Project Manager