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.

• 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.
• 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.

• 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.

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.
• 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.

Bachelor Of Science, Community Health

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

Master Of Business Administration