SUMMARY

The Senior Clinical Scientist is an individual contributor responsible for leading the analysis, and development of high-quality technical documentation for the company’s transcatheter mitral valve replacement (TMVR) system. This role partners closely with the Clinical, R&D, Regulatory, and Quality teams to gather inputs, validate assumptions, and translate procedural information into clear, accurate, submission-ready materials.

KEY RESPONSIBILITIES

• Become a subject matter expert in company’s products.
• Be responsible for preparing medical devices before use and troubleshooting any problems that arise during clinical cases.
• Analyze procedural learnings, engineering and clinical insights, as well as literature to drive continuing improvement and development.
• Develop structured, well-supported content that integrates procedural insights related to anatomical and medical parameters.
• Identify gaps or inconsistencies in evidence or understanding; initiate internal information-gathering efforts to close them.
• Own end-to-end documentation workflows, including planning, drafting, stakeholder alignment, review cycles, version control, and finalization.
• Serve as the internal hub for collecting and synthesizing scientific and procedural insights from clinical, R&D, regulatory, therapy development, and quality teams.
• Facilitate structured review cycles with subject-matter experts to ensure accuracy, clarity, and alignment.

EDUCATION

• Master’s in a scientific, biomedical, engineering, or related discipline.
• 7+ years of experience in clinical science, clinical affairs, medical writing, or clinical research within the medical device, cardiovascular, or related field.

EXPERIENCE

• Experience with structural heart, TMVR/TAVR, or other transcatheter systems.
• Experience reviewing clinical data, procedural imaging, and physician feedback to inform documentation.

KNOWEDLGE, SKILLS AND ABILITIES

• Familiarity with pivotal clinical trial design and execution.
• Exceptional written communication skills and attention to detail.
• Ability to quickly synthesize diverse data sources into cohesive, scientifically defensible narratives.
• Strong project ownership skills, with the ability to independently drive work from concept to completion.
• Comfortable navigating fast-paced, cross-functional environments with evolving priorities.
• Thrives as a self-directed expert contributor—not looking for a team to manage, but for work to own end-to-end.
• Relentless about clarity, accuracy, and scientific rigor.
• Curious, resourceful, and unafraid to dig for missing information.
• Brings calm structure to ambiguous problems and shifting priorities.
• Enjoys partnering across disciplines to seek input and build a shared understanding.