Canon Medical Systems USA, Inc.
Leader Medical Affairs
Manage clinical research and validation strategy for the product line, leading a team to achieve clinical research and validation objectives. Provide evidence-based guidance on scientific and clinical requirements for new products and features, support regulatory activities, and represent the company at educational and scientific industry events.
Key Responsibilities
- • Manage clinical research and validation strategy for the product-line.
- • Lead a team of clinical researchers to achieve clinical research and validation objectives including hypothesis-driven research and clinical evaluation projects at luminary institutions.
- • Provide evidence-based guidance on scientific and clinical requirements for new products and features to meet market needs.
- • Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.
- • Develop clinical product messaging and support Solutions Marketing to develop a go-to-market story.
- • Represent Canon as a spokesperson for product line technology at educational and scientific industry events.
- • Support regulatory activities by overseeing image quality review with external medical experts, providing technical/market expertise, and consulting on study/test-plan design.
- • Influence regulatory strategy by providing scientific and clinical consultation during early phase development.
- • Work with Strategic Development team to evaluate product claims and specifications.
- • Provide relevant evaluation results via appropriate channels to global business team.
- • Develop and execute clinical evaluation strategy for emerging products and features.
- • Explore expansion of clinical use.
- • Provide product validation results and communicate scientific and clinical benefits to company stakeholders such as Solutions Marketing for the purposes of product collateral development.
- • Support Solutions Marketing in developing collaterals.
- • Provide relevant scientific and clinical data, review collaterals for scientific accuracy, and work jointly with regulatory to ensure adherence to clinical claims and technical specifications.
- • Support Solutions Marketing on the development of scientific and clinical arguments for products and counter-arguments against competition.
- • Support education teams in development of videos and training programs by providing clinical and technical expertise and evidence.
- • Support Clinical Collaborations in Medical Advisory Board (MAB) activities related to the product line.
- • Support Clinical Collaborations by actively participating in hypothesis-based research grant proposal review committees for all product lines.
- • Work with Clinical Collaborations database administrator to ensure research activities are kept to schedule and recorded on a regular basis.
- • Participate in 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 Market Development, Solutions Marketing and Applications 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.
- • Represent Canon in industry organizational activities (e.g., MITA, IEC, AAPM, RSNA, ISMRM, ACR, ABR, QIBA, etc.).
Required
- • Strong communication skills, including credible interaction with prominent academicians and demonstrated skill at scientific writing and presenting.
- • Proven ability to operate effectively in a matrix organizational structure.
- • Detailed clinical and technical knowledge of CT, MR, X-ray, Ultrasound, or Vascular systems.
- • Proficiency with computers in windows-based software environment.
- • 10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager.
Preferred
- • Prefer experience with managing dynamic teams of individuals with diverse skills and expertise.
- • PhD preferred
- • Other PhD and/or MD medical imaging physics, engineering, or one of the clinical sciences.
This is a remote based position in the USA
- Manage clinical research and validation strategy for the product-line. Lead a team of clinical researchers to achieve clinical research and validation objectives including hypothesis-driven research and clinical evaluation projects at luminary institutions.
- Provide evidence-based guidance on scientific and clinical requirements for new products and features to meet market needs. Analyze and communicate technical and clinical product specification requirements from luminaries, market research teams, and via Medical Advisory Boards (MABs) to global business team.
- Develop clinical product messaging and support Solutions Marketing to develop a go-to-market story.
- Represent Canon as a spokesperson for product line technology at educational and scientific industry events.
- Support regulatory activities by overseeing image quality review with external medical experts, providing technical/market expertise, and consulting on study/test-plan design. Influence regulatory strategy by providing scientific and clinical consultation during early phase development.
- Work with Strategic Development team to evaluate product claims and specifications. Provide relevant evaluation results via appropriate channels to global business team.
- Develop and execute clinical evaluation strategy for emerging products and features. Explore expansion of clinical use. Provide product validation results and communicate scientific and clinical benefits to company stakeholders such as Solutions Marketing for the purposes of product collateral development.
- Support Solutions Marketing in developing collaterals. Provide relevant scientific and clinical data, review collaterals for scientific accuracy, and work jointly with regulatory to ensure adherence to clinical claims and technical specifications. Support Solutions Marketing on the development of scientific and clinical arguments for products and counter-arguments against competition.
- Support education teams in development of videos and training programs by providing clinical and technical expertise and evidence.
- Support Clinical Collaborations in Medical Advisory Board (MAB) activities related to the product line.
- Support Clinical Collaborations by actively participating in hypothesis-based research grant proposal review committees for all product lines.
- Work with Clinical Collaborations database administrator to ensure research activities are kept to schedule and recorded on a regular basis.
- Participate in 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 Market Development, Solutions Marketing and Applications 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.
- Represent Canon in industry organizational activities (e.g., MITA, IEC, AAPM, RSNA, ISMRM, ACR, ABR, QIBA, etc.).
- Strong communication skills, including credible interaction with prominent academicians and demonstrated skill at scientific writing and presenting.
- Proven ability to operate effectively in a matrix organizational structure.
- Detailed clinical and technical knowledge of CT, MR, X-ray, Ultrasound, or Vascular systems.
- Proficiency with computers in windows-based software environment.
- Prefer experience with managing dynamic teams of individuals with diverse skills and expertise.
- PhD preferred
- Other PhD and/or MD medical imaging physics, engineering, or one of the clinical sciences.
- 10 years’ experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting or 3 years of experience as a Medical Physicist, Scientist, or MD in a clinical hospital or clinical research setting plus 7 years of experience in healthcare industry as imaging scientist or research manager.
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