Kieron Day Ph.D. Email & Phone Number

High Wycombe

Responsible for developing, managing and leading the organisations clinical function at a global level. Role includes creation of Clinical Affairs Program and all associated processes, budgeting and team development to ensure successful execution of clinical milestones in compliance with applicable clinical / regulatory standards. Additionally, contribute to publications, presentations and the dissemination of clinical data to build the profile of Firstkind Medical’s capabilities and drive adoption within the multiple therapeutic spaces.Key Achievements • Designed, planned, cost and implement global Clinical Affairs Program for technology adoption across multiple therapy areas. • Development, budgeting, and management of trial protocols in the EU and US geographies.• Development of US adoption strategy; from FDA approval through to re-imbursement.• Identification of CRO partners, their assessment, audit and approval as preferred suppliers.• Build relationships with the KOLs and research groups best placed to deliver on Firstkind Medical’s clinical plans. • Maintained oversight of the regulatory and reimbursement landscape, through outsourced vendors, to align evidence generation requirements from key studies.• Created and initiated clinical SOPs to enable MDR adoption and ISO14155 / ICH GCP compliance. • Study centre management; overview of all processes from ensuring approvals to ensuring all necessary equipment, devices, training are in place to get a trial underway.• Input to and co-ordination of clinical trial publications.• Provide tactical clinical support and written copy to the commercial functions as needed and provide any necessary training.• Provide data and support to Head of Quality & Regulatory Affairs in the production of the CERs (Clinical Evaluation Reports) and vigilance requirements.

London, United Kingdom

To provide leadership in the oversight of development, coordination and execution of clinical affairs activities. Role includes creation of processes to ensure all project management activities including successful execution of clinical milestones in compliance with applicable clinical / regulatory standards and drive adoption within the clinical/pharma diagnostic spaces. Key Achievements • Created and initiated five-year strategic development plan for the launch of a new Class III Medical Device. • Developed Clinical Operational Plan for to compliment proposed Strategic Development Plan. • Created and initiated clinical SOPs to enable early MDR adoption and ISO14155 / ICH GCP compliance. • Worked with specific KOLs and research groups to deliver detailed clinical trial designs and study plans, including development of the statistical analysis plans. • Responsible for negotiating the necessary levels of IP ownership with KOL collaborators and grant funders.• Worked with KOLs and research groups to secure sufficient study funding from recognised grant organisations.• Development, maintenance and authorship of Clinical Evaluation Report.

Paris Area, France

To provide leadership in the of clinical affairs activities for EU and Eastern Europe.Key Achievements• Design, modification, evaluation and the implementation of Peripheral Arterial Disease trials to provide data for FDA approval of drug coated angioplasty balloon.• Development of KOL relationships and creation of technology based steering committee to initiate KOL led studies.• Creation of research protocols, guidelines, worksheets, materials and forms needed for execution of clinical trials.• Review and approve project deliverables such as protocols, study reports, study materials and data quality through monitoring.Work with Clinical Events Committees and Data Safety Monitoring Boards to ensure appropriate review of safety data

Europe, Middle East And Africa

Led clinical research teams across Europe, Middle East and Africa geographies. Responsible for all aspects of clinical research, from developing research strategies in emerging and established markets through to attaining regulatory approvals for new healthcare technologies.Key Achievements:-• Managed a group of nine Clinical Research Teams, active in 30 countries across EMEA.• Created and developed three new Research Teams to run Multinational Sponsored trials in Emerging Countries to enhance the organisations geographic footprint.• Sourced, assessed, contracted and managed seven CRO’s in the Middle East and Eastern Europe to run sponsored trials.• Lead the first St. Jude Medical recruitment of patients in to Multi-national research trials in five Middle East and four Eastern European Countries.• Provide strategic and operational direction to local affiliates, distributors and research organisations and ensure that studies are conducted in compliance with the highest local and international quality standards.• Setting objectives and performing appraisals for Research Team Leaders. • Budgeting and achieving cost objectives for all team and clinical research costs.• Development and initiation of new strategies for attainment of key trial recruitment goals e.g. development of CRO network in Middle East.• Assessment, due diligence and negotiation of clinical contracts with research organisations in key strategic geographies. Specifically, AmeRuss for Russia, and KRI in Poland.• Challenged country level Competent Authorities on issues relating to safety and efficacy of devices implanted into patients for both CE Marking and PMCF trials. In all cases, the organisation was able to continue implants.• Represent the views of industry, as a sanctioned ABHI representative, to government on the development of legislation relating to Clinical Research within Europe.

Emea

Provide direction, growth and development for Clinical Research Teams in Central and Northern Europe. Provide management, contractual and quality assessment of affiliate, distributor and CRO organisations. Facilitate cross-departmental communications in order to optimise group profile. Delegate tasks to team members with appropriate specialised skills both within and across borders.Key Achievements:-• Developing and maintaining effective working dialogue with key opinion leaders through the creation of Technology Advisory Boards e.g. Multi-Point Pacing Advisory Board, Heart Failure Advisory Board and so on.• Dissemination of clinical results, for example, 36 research papers published in 2014 as well as numerous oral abstracts presented at conference.• Provide individual development to enhance leadership and strategic impact of local research teams / organisations. This included providing a framework for resource sharing in countries with lower budgets e.g. combined needs of three countries utilised to justify a head count position.• Planning and managing successful clinical trials through close interaction with research department and technical sales representatives.• Integrating technology, sales and marketing departments to provide strategic input into the development of innovative research projects e.g. RADI CRT, FAMOUS, RIPCORD.

Uk

Create a Clinical Team to run all aspects research in the UK and Ireland. To provide strategic, operational and quality direction for clinical research to UK & Ireland function with primary links to European Clinical Department.Key Achievements:-• Identifying and placing clinical studies in selected hospitals.• Creation of 5 centres of excellence to lead multi-centre research trials within the NHS• Creation and Development of Research Fellows Group. This group initially had eight fellows focusing and working in centres of excellence. This was expanded to 18 over the course of 3 years and is ongoing. Note, fellows from the initial intakes are now consultants working in hospitals across the NHS.• Development of novel clinical studies to enhance research portfolio.• Managing teams to provide education and technical support at device implant and follow-up.• Design of clinical protocols and patient folders, including local Case Report Forms.

United Kingdom

Clinical Manager for the design and management of all research projects in the UK. Develop a team to meet the research goals of the organisation as defined by the Board.Key Achievements:-• Submitting and obtaining approval from regulatory for first ELA Medical FDA approved trial in the UK.• Conducted Pre-Trial, Initiation, Monitoring and Termination Visits.• Develop training for research professionals in varied clinical trials across region.• Provide education and training to personnel at study sites and in-house representatives regarding protocol, study requirements and research devices.

Doctor Of Philosophy (Ph.D.), Biology

Bachelor’S Degree, Biology, General, First Class (Hons)