Paula Robinson

Within the dynamic biotechnology space, provided clinical and operational leadership and management for important clinical development programs within the infectious disease area (dermatology and vaccine products). Responsibilities included protocol development to support the overall development plan for the compound(s), project implementation, study management and data management oversight, and summarization/publication of the results while ensuring that all aspects of the project were compliant with government regulations and GCP/ICH Guidelines. Provided team leadership in vendor selection, including development of the project specifications and requirements for Request for Proposals, vendor evaluation/contracting, and integrating multiple vendors into a single cohesive and effective project team that would deliver study results as specified by the development plan and corporate leadership (Senior Leadership Team and Board of Directors). Primarily responsible for development of project budgets and timelines, tracking of project progress against budget/timeline forecasts, and for ensuring that the project came in at budget and on-time.

As a key member of the early research and development team, guided strategic planning and option development for assigned projects in the early development space (pre-IND through POC). Primarily was responsible and accountable for management of project, development team, and resources ensuring that the overall strategy and goals for the corporate portfolio were met. Responsibilities included development and management of project controls, identification and management of project resources/budgets, coordinating manager for all development operation services (clinical study management, data management, statistics, and medical writing) for all assigned projects, and communication management (serving as the single-trusted source of information to support critical portfolio decisions by Executive Leadership) for assigned projects.

•Managed 27 CRAs (colleague and contractors) with respect to administration of all human resource issues, performance management, performance reviews, performance feedback, career development, and conflict resolution for colleagues and contract management for contractors. •Responsible for resourcing of monitoring services within CNS including site assignments, standardization of monitoring requirements and policies for CNS projects, creation and maintenance of performance metrics, and ensuring that all relevant/required training for each monitor was current. •Accountable for ensuring that monitoring resources were adequate and deployed to successfully meet corporate milestones for study conduct and summarization. •Served as primary reviewer on the CRO selection and contracting team. •Routinely negotiated with management for resource allocation and budgets. •Managed monitoring budgets for the CNS department

•In compliance with GCP/ICH Guidelines, designed, planned, and generated study protocols for assigned projects that were supportive of the overall CNS drug development strategy and individual compound strategy. •Led study teams that included colleagues from both clinical development and development operations (or CRO if development operations were placed externally) in study activities to support data collection, data/site monitoring, database design, data display tables, and reporting for assigned projects to meet study timelines. •Managed all operational aspects of study conduct for assigned protocols from site selection through study results reporting (both written and oral, internally and externally through research reports, investigator meetings, and professional/scientific meetings). •Managed study grants (with individual values up to $5M per study), which included negotiation and management of individual site grants. Responsible for managing budgets and authorizing all study payments for sites/service providers for assigned projects. •Routinely met and consulted with both internal and external experts when necessary to successfully support the management of assigned projects which included setting inclusion/exclusion criteria, management of specific safety concerns, and medical review of emerging adverse events.

•In accordance with GCPs/ICH Guidelines, monitored assigned sites for phase 2 and 3 clinical trials for protocol adherence, data accuracy, and regulatory compliance (average number of sites ~20). •Conducted training sessions for study conduct, CRF completion, and regulatory compliance both at large multi-centered investigator’s meetings and at individual clinical trial sites. •Developed and conducted both routine and specialized training sessions for colleague or CRO monitors. •Provided management and oversight to CRO who was contracted for monitoring activities for large phase 3 program. •As experience within the CRA role progressed, assumed additional study management responsibilities including authoring protocols and project management for assigned studies.

•Responsible for all aspects of data management, including data review, query generation and resolution, and database finalization for individual studies from all phases of Clinical Research. Working experience with database design/management tools and principles (Oracle Clinical®, SAS®). •Utilized scientific knowledge and clinical judgment to make sound data decisions that ensured integrity of data from database design through data reporting. •Responsible for generating and providing data displays used in NDA/MAA filings.