Mgr Medical Affairs - Clinical Scientist Sr

Canon USA & Affiliates; Raleigh (NC); Remote; USD 132,000 - 238,000; Full time

Job summary

Canon Medical Systems USA, Inc. in the United States is seeking a Manager, Medical Affairs - Clinical Scientist Sr to lead clinical research and evidence generation for imaging products.

You will collaborate with R&D, regulatory, and marketing to translate scientific results into product strategy and clinical claims. The role requires a PhD/MD level background with 5+ years in clinical physics or research, strong communication, and project management skills; it is remote with global

Qualifications

• PhD, MD, or equivalent in medical imaging physics, engineering, or 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.

Responsibilities

• 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.
• Work with Strategic Development team to evaluate product claims and specifications -- including testing of default protocols to ensure acceptance by industry standards.
• 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 stakeholders such as Solutions Marketing for collateral development.
• Support Solutions Marketing in developing collaterals. Review collaterals for scientific accuracy and work with regulatory to ensure adherence to claims.
• 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 activities and hypothesis-based research grant proposals.
• Work with Clinical Collaborations database administrator to ensure research activities are scheduled and recorded.
• 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 knowledge of Market Development, Solutions Marketing and Applications teams.
• Collaborate with healthcare economics personnel to translate economic benefits of clinical research programs for marketing and sales.
• Communicate known clinical or technical product issues and implement market-accepted solutions with relevant teams.

Skills

Strong communication skills

Project management

Scientific writing

Matrix organization collaboration

Education

PhD, MD, or equivalent in medical imaging physics, engineering, or clinical sciences

Job description

Mgr Medical Affairs - Clinical Scientist Sr - req1770

OVERVIEW

Work as part of a dynamic and fast-paced team of clinical and technical experts dedicated to positively impacting clinical care by effectively translating innovative imaging solutions to the clinical environment. Generate scientific and clinical evidence via product evaluations and research in order to highlight advantages of the technology while maintaining alignment with the business strategy. Participate as a technical expert of the product line technology and communicate product intelligence to internal teams, key partners, collaborators, and external experts. Effectively interact with multiple teams including R&D, global and local business, marketing solutions, regulatory, applications, and service. Manage key clinical customer/partner relationships in order to comprehensively support Canons business objectives while serving the needs of patients.

RESPONSIBILITIES

• This is a remote position
• 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.
• 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.).
• Pay Range $132K-$238K DOE

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.

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About us!

Canon Medical Systems USA, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Canon Medical Systems offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, sexual orientation, gender identity, religion, national origin, protected veteran status, or on the basis of disability. We invite you to join and become part of our Canon family.