Kansas City Metropolitan Area
Versatile Director with 17+ years of experience creating scalable processes and systems for world-class clinical research and biopharmaceutical service leaders ICON, PRA Health Sciences, and Quintiles. • Strengthen executive decision-making through key projects including enterprise dashboards serving ~7000 users and saving 110,000 hours per year via automation with industry-leading KPI and metric visibility. • Coach teams through project delivery best practices as Strategy Lead, developing tools and methodologies to guide organizations in solving challenges to successfully deliver $100M+ in clinical trials. • Project management insights honed via clinical research, corporate analytics, business intelligence, and strategy leadership roles, utilizing cross-functional understanding to drive large-scale programs. • Instrumental to successful integration of PRA Health Sciences into ICON, introducing critical programs to synchronize data for strategic planning, project pipeline management, and resource allocation. • Consistently expand skill base through coursework including Change Practitioner Certification (Prosci). • Expertise includes biosimilar, cell/gene therapy, chemical entity, cytokines, device, diagnostic, mAntibody, and vaccine drug types and therapeutic areas including CNS, cardiovascular, endocrinology, genitourinary, hematology, immunology, infectious disease, nephrology, oncology, and rare diseases.
Drove end-to-end clinical trial delivery success across wide range of therapeutic areas, leading teams of up to 9. Built project structure in collaboration with cross-functional team, determining number of sites and countries for trials, establishing timelines, building budget, and developing staffing/resource allocation. Quickly resolved project issues as point of escalation with clients and internal team. Clinical Project Management: • Served as Strategy Lead with single point of accountability for proposal strategy across 42 full proposals, 19 ballparks, and 17 bid defense meetings in variety of therapeutic areas including rare disease, CNS, cell and gene therapy, hematology, immunology, and oncology. • Directed $100M in aggregate projects, aligning scope with budget and delivering to critical milestones. • Cultivated trust with internal and external stakeholders, meeting with clients, account executives, and therapeutic experts to present ICON expertise and identify key clinical trial requirements including possible protocol designs, market inputs, enrollment rates, countries, KPIs, risk mitigation, and resourcing. Trusted Team Leadership: • Sparked business development with new and existing clients, securing 4 wins with known customers, 2 wins with new customers, 3 customers with delayed starts, and 4 top contender pending decisions. • Empowered clinical trial teams to resolve challenging issues as part of complex studies, guiding team members in study planning, execution, risk management, and negotiations to drive on-time delivery. • Strengthened organizational capabilities as Bid Defense Lead/Team Trainer and through onboarding training for new hires and newly promoted Directors of Project Delivery (DPD).
Spearheaded governance while managing project pipelines and resource allocation for ICON clinical research operations, leading team of 18. Collaborated with cross-functional teams to set priorities and objectives. • Designed modernization solution for combined ICON/PRA operations, assessing business capabilities, integrating corporate data/KPIs, and transforming processes into single tool for decision-making. • Served as Subject Matter Expert for data mapping and combining legacy data marts into single platform. • Automated data flow through mutual data staging area, saving $400K with significant timeline reduction.
Bolstered corporate performance through critical tools and systems, leading up to 40+ business analysts and solution leads. Drove strategic planning and resource allocation, directing reporting and tracking. Adhered to Software Development Life Cycle (SDLC) for project management and delivery. • Successfully integrated PRA Health Sciences data into ICON operations, extracting data from systems and warehouses, automating data retrieval processes, and synchronizing data for monthly aggregation. • Optimized business optimization processes across 7000 users, establishing Master Data Management (MDM) for data consolidation and Row-Level Security (RLS) for data security and access restrictions. • Aligned resources with project value through business governance tool for budgets, FTE, and CAPEX.
Optimized strategic planning and resource allocation though developing business roadmap of requests with focus on opportunity costs and prioritization. Led change management throughout project/system rollout. • Elevated executive decision-making, designing and building enterprise dashboards across global book of work across 350+ active studies and sharing KPIs with clients and internal stakeholders. • Introduced client-facing workflows to manage clinical trials including start-up, study management, and risk identification, ensuring teams and clients share up-to-date data and information. • Developed organizational structure, hiring team of business analysts focused on continuous improvement.
Lifted Contract Research Organization (CRO) performance via tools, dashboards, and process improvements, collaborating with Head of Clinical Operations to reinforce high-risk studies through training and systems. • Boosted global success through tools quantifying metrics/KPIs including Inclusion/Exclusion (I/E) criteria, CRA visit windows, CRA utilization, SDV rates, AE/SAE under-reporting trend analysis, CRF growth projections, CRF clearance rates, and backlog. • Provided FDA audit support for 1st biologic licenses application to FDA across for-cause and routine areas.
•Delivered complex multi-protocol project leadership across areas including site selection, monitoring visits, site management, protocol training, quality evaluation, study progress, documentation, and team coaching. • Expertise in investigational new drug (IND) and investigational device exemption (IDE) programs. • Served as lead Clinical Research Associate (CRA) in multi-protocol Parkinsons project, presenting to all CRAs and at investigator meetings and managing key opinion leader (KOL) sites.
Highlights include accurately maintaining clinical systems tracking site compliance and performance within project timelines.