Mgr Medical Affairs - Clinical Scientist Sr

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

Job summary

Canon Medical Systems USA, Inc. seeks a Sr Clinical Scientist to translate imaging technology into clinical value. You will lead clinical research, provide scientific guidance for new features, and support regulatory activities while collaborating with R&D, marketing, and global teams.

Remote-friendly role with emphasis on evidence-based validation and external collaborations. Ideal candidates hold a PhD/MD in medical imaging physics or related fields, with 5+ years in clinical research or

Qualifications

• PhD, MD, or equivalent in medical imaging physics, engineering, or clinical sciences.
• 5 years of experience with product line technology as Medical Physicist or Scientist in clinical settings.
• Strong written and oral communication with evidence-based presentation skills.
• Demonstrated project management and/or customer support capabilities.
• Understanding of current and emerging modality product line technologies.

Responsibilities

• Clinical research and evaluation projects at collaboration sites including data collection and protocol development.
• Provide evidence-based guidance on scientific/clinical requirements for new products.
• Support regulatory activities with technical/market expertise and study design input.
• Collaborate to evaluate product claims and conduct device testing to meet industry standards.
• Develop collateral with Solutions Marketing and provide scientific details for communication.

Skills

Scientific writing

Communication

Project management

Education

PhD/MD in medical imaging physics or equivalent

Tools

Windows

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.