Responsibilities
- Create and carry out translational research plans using in vitro, ex vivo, and in vivo methods to assess how medical devices function, perform, and impact safety.
- Build and verify experimental systems, tests, and procedures that reflect clinical results and help support submissions to regulatory agencies.
- Evaluate and interpret research data, then summarize findings in reports that inform device development and future clinical trial designs.
- Ensure accuracy and traceability of research data and documentation in alignment with GLP and GCP standards.
- Identify and engage subject matter experts, forming strong, trustworthy partnerships with external researchers, laboratories, and study locations.
- Monitor ongoing progress and outcomes from collaborative laboratory efforts.
- Maintain consistent and transparent communication with lead researchers and partner scientists.
- Act as a reliable scientific partner, able to discuss biological mechanisms and clinical relevance of device performance and design.
- Advance exploratory science by proposing new research angles, supporting additional study initiatives, and aiding in scientific publication.
- Serve as the internal authority on how devices are used clinically, their technical capabilities, and known constraints.
- Turn clinical observations into insights regarding device safety, effectiveness, ease of use, and procedural outcomes.
- Define and analyze patient populations most likely to benefit, considering anatomical, physiological, and disease-related characteristics.
- Transform clinical data into practical feedback for engineering and product design improvements.
- Shape product development direction and priorities using insights from real-world clinical use.
- Support evidence generation for off-label product safety and performance across multiple clinical investigations.
- Act as a communication link with commercial teams to align clinical and commercial activities at shared pulmonary sites.
- Deliver structured, regular updates on site operations, investigator engagement, and trial milestones.
- Collaborate on selecting key investigators and thought leaders, ensuring coordinated outreach and messaging.
- Balance clinical trial objectives with existing commercial presence while adhering to compliance rules for off-label use.
- Work closely with strategic partners conducting sponsored research projects.
- Provide clinical and technical guidance to ensure external studies support overall product strategy and data quality standards.
- Track progress, key findings, and outcomes from studies led by strategic partners.
- Incorporate insights from externally sponsored research into internal decision-making across clinical, engineering, and product teams.
- Serve as the main point of contact connecting Engineering, Clinical Affairs, Medical Affairs, Regulatory, and Data Analytics teams using translational data.
- Ensure study results are synthesized and communicated to support regulatory filings, product design, clinical planning, and marketing claims.
