Global Clinical Research Institute (GCRI) · The University of Western Australia
Translating science and medicine into business success: ⇒ Extensive Medical Affairs & Clinical Trials experience ⇒ Proven executive leadership in the Wound Care business ⇒ Innovative medical education ⇒ Achieving market access and reimbursement ⇒ Spearheading challenging and complex initiatives on a global scale ABOUT ME Experienced Medical and Clinical Affairs executive with 30 years’ expertise in Science and Medicine and a proven track record translating science and medicine into commercial success across North American, European and Asia-Pacific markets. Effective building, leading and improving teams to manage complex, diverse clinical projects to support all key company stakeholders, and drive new market opportunities. Strong interpersonal skills empower efficient collaboration in cross-functional matrix organisations, facilitating enhanced patient care through the speedy adoption of new products, therapies and technologies to market. EXPERIENCE: ⇛ Leadership in medium & small sized businesses through both direct and indirect reports including in matrix structures ⇛ Clinical Trials, Medical Affairs & compliance ⇛ Medical Education & Training ⇛ Market access and coding/reimbursement strategies ⇛ Development of clinical strategies and implementation plans to achieve the company’s objectives ⇛ Development and management of key opinion leader networks and advisory boards EXPERTISE: Healthcare | Medical Affairs | Clinical Trials | Wound Care | Market Access & Reimbursement | Medical Education | Medical Devices | Scientific Communications CONTACT ME: [email protected] [email protected]
Regulatory Affairs, Clinical Research and +1 skill
Wound Care, Clinical Development and +7 skills
Management team member, leading global Medical Affairs & Clinical Affairs activities. Clinical Trials: Successful implementation and execution of three European-based product registries & two pan-European multicenter RCT’s Oversight of Investigator Initiated Trial grants. Regulatory: Implementation of Clinical SOPs to meet EU MDR and FDA standards. Developed post-approval study CIP and associated documents for PMA submission to FDA. Responsible for clinical compliance to MDR audits. Implemented a novel hybrid, in-person and online Surgical Training & Proctoring program for training new users in the techniques required for successful implantation of the RefluxStop device. Key Opinion Leader development and management.
Developed and led clinical and commercial plan to launch product into US market. Led the development and implementation of coding & reimbursement plan. Commencement and oversight of 4 clinical trials including multicenter RCT and single center RCTs. Lead for KOL development and management and for communications with Wound Care organisations. Achieved Breakthrough Device Designation for the product in 2022.
Scientific and medical leadership within start-up investment team, assessing potential new investment opportunities in Wound Care and Biologics. Evaluating viability, developing and budgeting for, Phase I, IIa and IIb, and III clinical trials, including onsite evaluation of research sites and infrastructure. Competitor analysis, investment modelling, and presentation out to potential investors.