Hilary A. Partin

Clinical program strategy and operational oversight from vendor selection through timeline and budget management

Responsible for strategic and operational oversight, execution, and delivery of all clinical programs. Co-lead inspection readiness activities, and acts as subject matter expert during regulatory inspections, in addition to the responsibilities of AD role.

Responsible for operational execution and delivery of all clinical programs, on-time and within budget by providing strategic and tactical direction to multiple cross-functional project teams. Managed internal associates, vendor, and investigator stakeholders in a matrixed environment. Led review process of TFLs and data review meetings in preparation for clinical study reports and regulatory submissions. Developed and implemented enhanced clinical SOPs and associated workflows, resulting in: * Semi-annual team member evaluation process to aid in documenting team member achievements and opportunities for improvement * Contingency and continuity plans for programs and clinical team * Standard clinical trial oversight process and metrics, including piloting and inclusion of CluePoints risk-based monitoring process * Augmented patient retention program to further reduce current termination rate of 18% * Reduced average time for protocol creation (concept to signed protocol) from 9 weeks to 6 weeks * Co-wrote 5 synopses and 5 protocols with no amendments with Medical representative * Enrolled Phase 3 molluscum contagiosum program and maximum use pharmacokinetic trial early and within budget; 37% and 63% early, respectively

Managed daily cross-functional activities for global device and cosmetic studies in matrix environment, including line management of the monitoring team. Responsible for developing and managing trial budgets and timelines to ensure budgets and schedules are met, focusing on proactive risk identification and management Contributed to the design and development of the program strategy and protocol design through reviewing and approving trial-related documents (e.g. monitoring plans, statistical analysis plans and TFLs, clinical study reports, regulatory submissions) Provided input for evaluating RFPs and participate in selection of CROs and vendors

Promoted to newly created role and department, charged with designing and implementing strategies for cultivating and enhancing site-sponsor relationships Developed standard offering of site engagement options for the department based on trial phase and indication Ensured consistent communication across CRO and internal parties by creating standardized talking points, letters, and videos for each trial team Managed relationships with investigators and sites across the company portfolio to present unified UCB approach Hired and mentored new team members as success drove incorporation of site engagement into all studies

Oversaw clinical operations for large, global studies in immunologic and neurologic indications Enhanced site engagement through innovative approaches for virtual and face to face investigator meeting conduct, and operational advisory boards Managed partners according to contracted scope, timelines, and partnership metrics Provided feedback for partnership hot spots to be addressed through governance, and successfully piloted first trial within new partnership oversight manual Drove compliance and quality at investigational sites and external vendors though project metrics and checkpoints, including conduct of CRA and site assessment visits Trained internal and external team members on relevant protocols and regulations Drafted, reviewed, and facilitated regulatory approvals, protocols and protocol summaries, and clinical study reports

Supervised, trained, and supported team of 18 CRAs on Phase II global studies in Asia, Europe, and North America Managed internal and external vendors, including ePRO, IXRS, ECG, and data management Created and implemented project plans and remote monitoring processes to facilitate trial execution Developed training program and mentored new associates

Protected rights, safety, and well-being of subjects and ensured site compliance with the clinical trial protocol through on-site and remote communication, and source data verification Led team of 10-12 CRAs on global studies in Europe and North America Developed and implemented project and clinical monitoring plans Liaised between sponsor and CRA team to ensure quality and exceed expectations Trained internal and external teams on protocols and regulatory guidelines, and mentored new team members

Managed daily activities of a cardiovascular biology research laboratory, designed and conducted independent experiments, including development of murine surgical models Trained rotating medical, graduate, and undergraduate students Presented at American Heart Association