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Senior Manager, Evidence Strategy and Trial Design

Company: Columbia Association, Inc.
Location: Cincinnati
Posted on: January 27, 2023

Job Description:

Senior Manager, Evidence Strategy and Trial Design Tuesday, December 20, 2022 AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator - Synergy--- Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip - Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF--- Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE - probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit or follow us on Twitter @AtriCure.

Wefoster a culture of inclusion by embracing diverse experiences and individualswhere everyone's authentic self is welcome. We offer supportingprograms and resources that provide enriching and equitable opportunities foreach person to contribute professionally and personally. POSITION SUMMARY: The position is responsible for supporting the development of the clinical evidence strategy and designing clinical trials (IDE, post-market) in alignment with the company's strategic goals. Key collaborators include physician KOLs and cross-functional leaders in Marketing, Medical Affairs, Regulatory, R&D, Scientific and Clinical affairs. The position will also serve as a subject matter expert in evaluating the investigator-initiated research proposals.

  • Engage with the cross-functional leaders in Marketing, R&D, Scientific and Regulatory Affairs to understand business and evidence needs.
  • Create advisory board, develop content, and moderate the meetings.
  • Design clinical trials based on the business and evidence needs, in close collaboration with the physician KOLs/ Steering Committee and cross-functional team.
  • Develop FDA pre-submission documents and participate in the FDA pre-submission meetings, as needed, in collaboration Regulatory Affairs.
  • Author clinical trial protocol synopsis (initial version and future iterations) and contribute to the development and review of the case report forms.
  • Collaborate with the KOLs and cross-functional team in responding to the FDA questions (e.g., design considerations, deficiencies) on IDE, PMA and 510k submissions.
  • Author scientific sections of the Clinical Study Report and the PMA submission.
  • Participate in pre-PMA meetings with the FDA and collaborate with KOLs in responding to the FDA questions.
  • For international submission (PMDA, CFDA), serve as scientific expert in responding to the question from Regulatory authorities.
  • Review investigator-sponsored research (ISR) proposals for scientific validity and appropriateness of study design and provide necessary support in creating alignment between ISR proposal and evidence needs.
  • Remain up to date on US and international society guidelines/ expert consensus on the treatment of atrial fibrillation, left atrial appendage management, and pain management.
  • Participate in the early stages of product development to determine the clinical strategy needed for product clearance, approval, or indication expansion, and support the development of clinical evaluation plan.
  • Provide scientific voice, perspective, and accuracy for company initiatives
  • Maintain credibility by being on the leading edge on state of science and shifts in clinical and treatment paradigms
  • Perform other duties as needed or assigned.
    • Regular and predictable worksite attendance
    • Ability to work under fast-paced conditions
    • Ability to make decisions and use good judgment
    • Ability to prioritize various duties and multitask as required
    • Ability to successfully work with others
    • Additional duties as assigned
      • 10+ years of clinical, regulatory, scientific, or medical affairs experience in a medical device manufacturing environment. 7+ years with advanced degree (MD/PhD)
      • Thorough understanding of clinical trials design methodologies
      • Sound knowledge of FDA requirements for clinical trial and fair understanding of international regulatory environment.
      • Knowledge of theories, principles, and concepts of cardiac arrhythmia in the context of device therapy, electrophysiology, and surgical medicine.
      • Thoughtful, energetic individual with the ability to communicate the scientific strategy to internal and external audience
      • Excellent written and oral communicator and strategic thinker capable of communicating clearly to a variety of audiences worldwide. Ability to synthesize information from scientific/medical literature and communicate responses to complex questions in scientific and layperson's terms
      • Demonstrated ability to effectively manage multiple projects at varying stages of development under time and resource pressure
      • Ability to work independently, as part of a team and manage a team.
      • Effective interpersonal skills/diplomacy and problem-solving techniques
      • Proficient computer skills; able to use standardized office software products, ie., Microsoft Word, Excel, PowerPoint, etc.
      • Ability to travel 20-30%
        • A PhD / MD with expe rience in atrial fibrillation research
          • Ability to regularly walk, sit, or stand as required
          • Ability to occasionally bend and push/pull
          • Ability to occasionally lift up to 25 pounds
          • Ability to pass pre-employment drug screen and background check
            AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, PetInsurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: participates in the federal E-Verify program to confirm the identity of and employmentauthorization of all newly hired employees. For further information about the E-Verify program, please click here is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Keywords: Columbia Association, Inc., Cincinnati , Senior Manager, Evidence Strategy and Trial Design, Executive , Cincinnati, Ohio

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