•Responsible for initiating and closing on global new business opportunities. It includes overseeing organizational awareness of the pipeline process, projects, technologies, & capabilities.•Managing assessment and internal due diligence of emerging technology.•Driving financial analysis and development of business proposals.•Developing strategic participation plans for opportunity entry and competitive leadership. It includes delivering presentations & bid defenses.•Responsible for establishing, maintaining and developing relationships with KOLs, academic & scientific institutions, global clinical sites, sponsors, investors and partners.•Accountable for bringing all cross-functional teams (i.e. Clinical Operations, Legal & Regulatory, Project Management, Quality Assurance, Marketing, Finance) to facilitate and achieve turning prospective opportunities into concrete business agreements. It includes sharing best practices and experiences from emerging technology, cultural barriers, market access, patient care process, reimbursement strategies, regulatory submission, and KOL & site development.•Accountable for demonstrating, maintaining an understanding of the Medical Device market and providing strategic leadership and development as the Master Subject Expert in cardiovascular disease related technologies; ensuring regular market analysis and feedback to the team and stakeholders.

Consultancy on new business development focus on marketing and clinical operations for US companies in projects OUS.BUSINESS DEVELOPMENT:•Developed business, marketing and clinical plans through the understanding of the healthcare and medical device product/service life cycle (regulatory pathways, reimbursement, and standard of care, distribution channel/legal representation, cultural barriers, communication, and other).•Facilitated the introduction to distributors, local representatives, and KOLs.•Planned strategic development for product launching and market penetration.•Oversaw the execution of strategic marketing and clinical plans.•Interacted with cross-functional teams and facilitated the business and clinical development strategy on post-marketed products. CLINICAL OPERATIONS:•Prepared market analysis and reports (regulatory environment & pathway, experience & capabilities of physicians and clinical sites) for prospective clients looking to conduct clinical research and/or market penetration out of the US.•Prepared, conducted and followed-up on country and clinical site feasibilities.•Supported country, principal investigator, and site qualification and selection.•Aided with the development and/or review of study documents (protocol, investigator brochure, informed consent forms, instructions for use, insurance policies)•Lead, manage, and follow-up regulatory submissions/approvals, clinical site and PI budget and contracts, enrollment and follow-up strategy, site management.•Lead and oversaw investigational product logistics (import licenses, customs clearance and inventory management).•Ensured guidance and interaction with all vendors as requested (EDC, Depots, Translation, CROs, contractors).

Privately held Site Management Organization (SMO) that combined a patient care, research and education strategy with focus on cardio-neuro-vascular disease.

Medical Device Company that developed, patented, CE Marked, and marketed innovative therapies for the treatment of coronary disease. Vice President, Operations Europe & L.A. August 2003 – August 2005 General Manager, Latin America (L.A.) June 2000 – July 2003 General Manager Colombia April 1999 – May 2000