Mgr Medical Affairs - Clinical Scientist

• This is a remote based position in the USA
• KOL and strategic partner engagement
• Develop and implement strategy to identify, engage, and sustain relationships with KOLs and strategic partners across clinical specialties for modality.
• Ensure KOL and partner engagement activities align with corporate and modality strategies, product development / technology roadmaps, and regional market needs.
• Maintain standardized and compliant engagement frameworks, governance models, and reporting mechanisms.
• Coordinate communications between KOLs, strategic partners, modality team(s) and other Canon stakeholders.

Clinical research and validation

• Manage collaborative research and clinical evaluation projects at collaboration/partner sites including data collection, protocol development, data acquisition, phantom studies, equipment evaluations, post processing, co-writing papers, IP and technology transfer support, and development of presentations.
• Provide evidence-based guidance on scientific and clinical requirements for new products and features to meet market needs.
• Support regulatory activities providing technical/market expertise, and reviewing study/test-plan design. Influence regulatory specifications and claims strategy by providing scientific and clinical consultation during early phase development.
• Support, design, and execute internal and external product evaluations. Explore expansion of clinical use. Provide product validation results and communicate scientific and clinical benefits to company stakeholders including modality business unit (BU) teams, marketing, and applications for the purposes of product collateral development and education.
• Capitalize activities through the development of marketing collateral by leveraging relevant scientific and clinical data, ensuring scientific accuracy through thorough review, and collaborating with regulatory to maintain compliance with clinical claims and technical specifications.

Cross-functional collaboration

• Work with modality BU team(s) to evaluate product claims and specifications, including testing of default protocols to ensure acceptance by industry standards (e.g., The Joint Commission and ACR). Communicate relevant evaluation results via appropriate channels to internal and global research teams.
• Contribute to the development of scientific and clinical value propositions for modality products, as well as competitive differentiation and counter-arguments.
• Support education teams in development of videos and training programs by providing clinical and technical expertise and evidence.
• Support Medical Advisory Board (MAB), User Group, or similar forums related to the product line.
• Work with database administrator(s) to ensure research activities are kept to schedule, remain compliant, and updates are recorded on a regular basis.
• Participate in modality BU and Medical Affairs meetings and provide clinical and technical expertise to support business decisions.
• Provide clinical, technical, and product education to enhance the knowledge base of the Commercial, Marketing, Applications, and Service teams.
• Collaborate with healthcare economics personnel to translate economic benefits of clinical research programs for the benefit of marketing and sales programs.
• Communicate known clinical or technical product issues via appropriate channels. Work with relevant team(s) (e.g., Strategic Development, Regulatory, and Service) to quickly implement market-accepted solutions.
• Perform all responsibilities in full compliance with regulatory and legal requirements, and within industry guidelines such as the AdvaMed Code of Ethics.
• Represent Canon as a spokesperson for product line technology at educational and scientific industry events.
• Represent Canon in industry organizational activities (e.g., AdvaMed, MITA, IEC, AAPM, RSNA, ISMRM, ACR, ABR, QIBA, etc.).
• Other duties as assigned.
• Pay Range $112k-$203K DOE