Executive / senior industry position
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San Francisco, CA, US
Velano is seeking an accomplished, seasoned VP/Chief Medical Officer to help aid in the growth of our company and the development of a standard-of-care for a series of novel technologies. Central to the role is expertise and a proven track record launching novel, life-enhancing technologies for use in hospital medicine – both in the U.S. and abroad. The candidate will be responsible as a member of the Executive team to establish the clinical and medical foundation for a new and enhanced way to practice medicine at the intersection of vascular access, blood collection and infection prevention.
Reporting to the CEO, this role will be responsible for further developing and leading the Clinical and Medical Affairs function at a time of high growth. This leader will work closely with all functions in the organization, building and leading a high-performing team of pioneering industry experts.
Responsibilities & Competencies:
- Work with Commercial and R&D teams in the early stages of product development to gather clinical input; construct appropriate quantitative / qualitative market research, and ensure design and execution in compliance with global regulatory, legislative, and medical/health requirements
- Serve as escalated level of customer support for medically related product questions
- Partner with Regulatory Affairs, Operations and Quality Assurance in the preparation of 510(k) clearance and CE Mark submissions, as well as serve as medical expert in meetings with FDA and other health agencies
- Support the Quality Affairs organization in preparation for all FDA, Notified Body, and other agency audits and to provide medical leadership in support, inspections, NC/CAPAs and other quality functions
- Collaborate with commercial team in the development of Velano Scientific Evidence and Medical Communication Strategy; including the authorship of clinical study reports and subsequent publications and presentations of study outcomes and clinical practice. Ensure strong scientific presence at major medical conferences, aligned with commercial strategy
- Maintain subject matter expertise through review of scientific literature, observation of medical/clinical practice trends, and participation in industry meetings. Serve as resource and expert for management team, commercial organization and other internal stakeholders
- Ensure the highest quality and integrity across all aspects of clinical / medical information and communications; including but not limited to content for customer education, commercial clinical team, medical information requests and promotional review
- Strengthen engagement with medical community through various channels, including advisory boards, user meetings, CME programs, academic collaborations and professional societies. Build and maintain key opinion leader relationships consistent with commercial and development objectives.
- Establish the systems, processes and procedures to ensure safety and performance of marketed products. Potential functions include: complaint investigation, medical review, adverse event reporting, trend analysis, health hazard evaluation (HHE) and clinical evaluation reports (CER).
- Work with the commercial team (sales and marketing) to design internal / external training programs and support the delivery of those training events as requested
- Collaborate with management to evaluate growth opportunities based on unmet clinical needs, emerging technology, and competitive landscape
- Establish and lead the systems, process and procedures for HCP contracting; including establishment of FMV tiers, contracting and review best practices and infrastructure to support the growth of the commercial clinical organization
- Establish and manage the Good Promotional Practices program and ensure that the delivery of off-label information is handled in a manner that follows all FDA and Governmental guidance
- Support and enhance talent pipeline by helping recruit, developing and rewarding high-performing employees
- Direct annual budget for department and associated clinical and medical programs
Skills/Experience Experience Requirements:
- Valid, state-issued medical license in good standing
- 5 or more years of executive experience with medical device companies in positions of medical affairs, training, clinical
- 10 or more years of clinical experience in a hospital setting with demonstrated achievements
- Experience developing and implementing training programs
- Experience in areas pertaining to clinical risk, safety reviews including FMEA and risk versus benefit analysis, adverse experience/event reporting (MDR), and protocol design
- Experience with educating staff, leadership and others regarding all issues facing vascular access products and practice
- Excellent communication, organization and leadership skills
- Strong scientific background, deep clinical experience, and clinical publishing track record
- Demonstrated ability to work both at the strategic and tactical level with a can-do attitude to do what it takes to get the job done
- Proven high sense of urgency in driving critical initiatives, as well as positive attitude and unwavering motivation to succeed
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