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.
• 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.

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.
• 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.

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.

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.
• 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.

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.
• 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.
• 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.
• 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.
• Development of novel clinical studies to enhance research portfolio.
• Managing teams to provide education and technical support at device implant and follow-up.

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)