Mgr Medical Affairs - Clinical Scientist Sr

About the role

This is a remote position focused on clinical research and validation. The role involves managing collaborative research and clinical evaluation projects at partner sites, providing evidence-based guidance on scientific and clinical requirements for new products, and supporting regulatory activities.

Responsibilities

• 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
• Work with Strategic Development team 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
• 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 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
• Perform all responsibilities in full compliance with regulatory and legal requirements, and industry within guidelines
• Represent Canon as a spokesperson for product line technology at educational and scientific industry events
• Represent Canon in industry organizational activities (e.g., MITA, IEC, AAPM, RSNA, ISMRM, ACR, ABR, QIBA, etc.)

Qualifications

• PhD, MD, or equivalent in medical imaging physics, engineering, or one of the clinical sciences
• 5 years of experience working with the product line technology as a Medical Physicist, Scientist, or MD in a clinical physics or clinical research setting
• Strong communication skills, including credible interaction with prominent academics and physicians and demonstrated skill at scientific writing and presenting
• Demonstrated project management and/or customer support skills
• Demonstrated understanding of current and emerging products and technology in modality product line
• Detailed clinical and technical knowledge of product line technologies (CT, Healthcare IT, MI, MR, XR, Ultrasound and/or Interventional systems)
• Proficiency with computers in windows-based software environment
• Proven ability to operate effectively in a matrix organizational structure
• Must be capable of lifting up to 25 pounds

Pay

$132K-$238K DOE