Clinical Development Scientist (Minneapolis, MN)

Summary:

In this critical role, the Clinical Development Scientist will support and be accountable for clinical evidence strategy development, delivery, and dissemination throughout the product life cycle. This role involves executing clinical and economic evidence activities for medical devices, from ideation through post-market. The Clinical Development Scientist will ensure clinical data is generated to support product claims, reimbursement, health economic outcomes, and market access strategies.

Responsibilities:

• Execute clinical evidence activities across the product development life cycle for medical devices.
• Develop and author clinical trial designs, including scientific justification and analysis plan guidance.
• Ensure clinical data supports business objectives, product claims, and market strategies.
• Contribute to clinical study reports, evaluation reports, abstracts, presentations, and peer-reviewed publications.
• Collaborate closely with key opinion leaders, investigators, and external stakeholders.
• Support clinical evidence discussions with regulatory bodies, notified bodies, and physician advisory boards.
• Develop rapport across organizational levels to influence decision-making and facilitate change.
• Foster a collaborative team environment and adapt to changing priorities.

Requirements:

• PhD or MD in science, engineering, or a medical field, with a background in medical device design and/or Structural Heart procedures preferred.
• 5+ years of experience in clinical research, including methodology, statistics, and trial design.
• Strong medical writing and verbal communication skills, with experience in technical/clinical presentations.
• Proficiency in conducting literature searches relevant to clinical and medical research.
• Knowledge of clinical research, medical device development processes, regulatory requirements, and good clinical practices.
• Ability to meet physical, cognitive, and environmental job demands with or without accommodation.
• Willingness to travel up to 25% of the time.

Department: Direct Clients
This is a full time position