Nicole Stephenson Email & Phone Number

● Responsible for executing the company strategy and applying it to the clinical studies and daily operations with the goal of commercialization of the cellular therapy investigational product.● Responsible for planning and directing the work of the Clinical Affairs department, monitoring work and taking corrective action when necessary.● Responsible for departmental hiring decisions and employee development.● Coordinate all clinical study operations globally in which Cook MyoSite Inc. participates, and ensure execution is in accordance with applicable regulations and applicable internal quality system procedures. ● Manage internal resources, external strategic partners, consultants, vendors and investigational budgets to ensure timely and cost-effective implementation of clinical development plans. ● Contribute to risk resolution by monitoring and escalating project risks to executive leadership. ● Ensure effective communication and coordination with clinical study sites, physicians, and other Cook Group companies or institutions necessary for conducting clinical studies. ● Oversee clinical trial operations to ensure integrity of data and GCP compliance. ● Oversee direct reports: create and execute short and long-term staff development plans.

● Primarily tasked with Clinical Affairs departmental decisions and output on clinical study activitiesrelated to quality, operations, and the Cook MyoSite business with the goal of commercialization of the cellular therapy investigational product.● Front Line Leadership functions include managing departmental resources appropriately, assessingperformance, providing feedback, and identifying gaps while also providing oversight of all clinicalstudy operations.● Directly assist in the coordination of all clinical studies globally in which Cook MyoSite participates.● Ensure clinical trial execution is in accordance with applicable regulations and standards andapplicable quality system procedures.● Establish systems for, and ensure the appropriate preparation and review of, all study-related essential documents, plans, training materials, and relevant regulatory updates occur. ● Provide leadership to and oversight of clinical study teams and study vendors, including review ofclinical trial agreements and budgets.● Effectively communicate, coordinate, and establish relationships with clinical study sites, physicians,and other Cook Group companies or institutions necessary for conducting clinical studies.● Serve as an expert on the investigational cell therapy product and procedures performed by the clinical sites.● Provide training and case support to clinical sites and clinical study teams, as needed.● Ensure mechanisms exist for clinical studies to select sites, track subject enrollment, and studyprogress.● Oversee the clinical development directorate training program.● Oversee patient recruitment activities for all Cook MyoSite clinical studies.

● Managed the Field Product Specialist team and helped ensure clinical trial and company goals were met.● Served as the technical expert on the cellular therapy investigational product, procedures, and clinical trials.● Provided clinical support through direct physician and Research Coordinator interaction, education, and procedural observation.● Provided feedback and process improvements to the executive leadership team to assist withcommercialization and clinical development efforts.● Helped identify opportunities for improving compliance with clinical study protocols/procedures,finding solutions for improved patient comfort, increased patient enrollment with individualized site recruitment plans,, and shared best practices with internal teams.

Kansas City, Missouri Area

● Successfully managed a large sales territory in the Critical Care strategic business unit of Cook Medical (Kansas, Nebraska, western Missouri, and Oklahoma) for 10 years. ● Promoted sales through direct physician interactions in the following call points; Surgery (CT, Trauma, General), Pulmonology, Anesthesia, Emergency Medicine, Pediatrics, Neonatology, Hospital Intensivists, Value Analysis Teams, Materials Management, Distributors and Infection Control.● Supported patient care in multiple hospital departments with products for managing difficult airway, centesis and drainage, vascular access, percutaneous tracheostomy, endobronchial ultrasound, one-lung isolation and enteral feeding.

Bachelor Of Science, Community Health

Activities and Societies: Kappa Kappa Gamma, University of Kansas Fraternity and Sorority Foundation

Master Of Business Administration