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Mgr Medical Affairs - Clinical Development Sr - HIT - req1494

OVERVIEW

Works independently and 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. Drives clinical initiatives on research and strategic development activities, while serving as a champion for KOL activation and relationship management at strategic sites while serving the needs of patients. Participates as a clinical expert of the product line technology and communicates clinical intelligence to internal teams and key partners, collaborators, and external experts. Support marketing in developing collaterals and review of collaterals for clinical accuracy and adherence to clinical claims. Effectively interacts with multiple teams including R&D, global and local business, marketing, regulatory, applications, and service.

RESPONSIBILITIES

+ Clinical research and validation. Support collaborative research and clinical evaluation projects at collaboration/partner sites including data collection, protocol development, data acquisition, phantom studies, equipment evaluations, post processing, and development of presentations.

+ Provide evidence-based guidance on clinical requirements for new products and features to meet market needs.

+ Learn, maintain, and advance expertise in areas relevant to the product line and support the strategic goals and objectives of the business unit.

+ Support regulatory activities by managing image quality review with external medical experts, providing clinical expertise, and reviewing study/test-plan design. Influence regulatory specifications and claims strategy by providing clinical consultation during early phase development.

+ Work with Strategic Development team to evaluate product claims from a clinical stand-point. Communicate relevant evaluation results via appropriate channels to internal and global teams. Communicate known clinical or technical product issues via appropriate channels and work with relevant teams to support resolution.

+ Manage, design, and execute internal and external product evaluations. Explore expansion of clinical use. Provide clinical validation results and communicate clinical benefits to company stakeholders such as sales and marketing.

+ Support marketing in developing collaterals and review of collaterals for clinical accuracy and adherence to clinical claims.

+ Take ownership of clinical development KOL activation with a priority focus on unique and/or disruptive technologies.

+ Lead the management of clinical components of support at strategic KOL sites and coordinate resources across internal and external cross functional teams and stakeholders, including strategic development, education, applications, and service.

+ Drive KOL growth at selected FOK deployments and identified Medical Affairs KOL sites.

+ Participate in Medical Advisory Board (MAB) activities related to the product line and work with the KOL/contract database administrator to ensure activities are appropriately documented.

+ Clinical product line representative for hypothesis-based research grant proposal review committees for all product lines.

+ Support clinical KOL program initiatives, including creation, deployment, and maintenance activities.

+ Participate in BU and Medical Affairs meetings and provide clinical expertise to support business decisions.

+ Share clinical, technical, and product knowledge to support strategic development, marketing, applications, and education teams.

+ Collaborate with healthcare economics personnel to translate economic benefits of clinical research programs for the benefit of marketing and sales programs.

+ Support Applications to develop market-optimized protocols/sequences/presets and positively influence equipment optimization.

+ Perform all responsibilities in full compliance with regulatory and legal requirements, and within industry guidelines.

QUALIFICATIONS

+ Strong communication skills, including credible interaction with prominent physicians and demonstrated skill at writing and presenting.

+ Demonstrated project management and/or customer support skills.

+ Demonstrated understanding of current and emerging products and technology in product line.

+ Prefer detailed clinical and technical knowledge of product line technologies (CT, MR, X-ray UL or Vascular systems).

+ Proficiency with computers in windows-based software environment.

+ Proven ability to operate effectively in a matrix organizational structure.

+ This position will require 50% field-based travel.

+ 4 Year / bachelor's degree or Equivalent work experience in lieu of degree.

+ 10 years' experience working with and operating the product line technology in a clinical hospital, industry position, or clinical research setting.

+ 8+ years working in a marketing clinical role in a medical imaging company.

+ 8+ years in supporting clinical investigations including scientific writing/editing.

+ Multi-Modality: HIT

+ 8+ years clinical product development, marketing or sales.

+ Remote; anywhere from the USA.

+ Base salary in range of $180K, plus bonus. DOE.

_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._