*Remote position with travel to Minneapolis, MN Office as required.
*Company Headquarters in Mason, OH
REPORTS TO: VP, Global Scientific Affairs and Evidence Strategy
The position is responsible for supporting the development of the evidence strategy in alignment with the strategic goals of the company by interacting with the cross-functional leaders in Marketing, R&D, Scientific, Medical, Regulatory and Clinical affairs and thought leaders. The position will design clinical trials (IDE, post-market) and assess the design of investigator-initiated research proposals, as necessary.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Engage with the cross-functional leaders in Marketing, R&D, Scientific, Clinical, Regulatory and Medical Affairs departments to support the development of evidence strategy and roadmaps
- Participate in early stages of product development to determine the clinical evidence needed for product approval / indication expansion.
- Create clinical study synopsis based on the evidence needs and in collaboration with the thought leaders
- Support FDA pre-submission, response to the IDE deficiencies and study design considerations and questions following PMA submissions in collaboration with the cross functional team
- 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.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- 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
- Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.
- 10+ years of clinical, regulatory, scientific or medical affairs experience in a medical device manufacturing environment
- Knowledge of theories, principles, and concepts of cardiac arrhythmia in the context of device therapy, electrophysiology and surgical medicine.
- Knowledge of clinical study design principals and pertinent FDA and International regulatory guidelines
- 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 with experience 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