Description
SUMMARY Medical device industry veteran with experience with product development, clinical strategies implementations, regulatory approvals, clinical marketing and market development. Recognized professional who is persistent and thrives in a multi-level, fast-paced environment. Keen, innovative and dedicated individual with strong ethical and moral values. Creative thinker with the ability to challenge norm and tackle unresolved problems. Excellent communications skills that lead to successes in negotiating and collaborating with board members, investors, internal and external customers, product users, corporate partners, regulatory agencies, suppliers, business partners and consultants. Motivated individual who understand how to operate within a regulated industry with aggressive timelines. Proven background in analyzing problems and proposing optimal solutions, fulfilling customer needs and meeting corporate goals. LEADERSHIP, MANAGEMENT AND MARKET DEVELOPMENT * Established very strong relationships with key leaders, societies representatives and regulatory agencies * Development and management of project conception to successful start-up and validation, including scope definition, functionality, design, timelines development, overall project quality, budget control and execution * Led program design, development, planning, implementation and management, including selection of partners, vendors and related audits, as well as budget forecasting, staffing planning, recruitment and development. Development and implementation of effective process improvements * Financial budgeting and analysis, strategic planning, project and resource assessments, implementation and execution * Proficiency in researching and assessing specific clinical market development opportunities and scenarios * Analytical background with ability to identify short and long-term clinical research and marketing opportunities * Led teams and projects with effective communications with the various cross functional groups * Trained and mentored high-performance individuals and teams * Developed clinical strategies, tactics and implementation plans leading to successful product approvals * Strategic and process oriented with proven ability to develop, analyze, execute, lead and manage scientifically valid human research studies, from feasibility to post-market, in various therapies. KEY COMPETENCIES: * Cardiovascular, Peripheral, Endovascular * Statistical analysis expertise for regulatory (AAA, TAA & TAAA), Coronary and Venous therapies submissions & approvals, abstracts, presentations expertise & publications * EDC / CTMS / Safety systems developer * Budget and contract negotiations skills * Vendor/partner Identification and collaboration * Case support & field training/education * Investigators & Research Coordinators, clinical * Clinical Investigational Plan writing, including IFUs, IBs Specialists and distributors training & CRFs development * Development of strong relationships with KOLs * Functional expert identification and collaboration * Strategic planning and clinical market development * SOPs and work instructions writing
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