Sr. Clinical Scientist
If you’re the kind of Clinical Scientist who wants to own the story behind the data, not just contribute slides or sections, this role was built for you. Our start-up client is adding a Senior Clinical Scientist to take end-to-end ownership of the scientific and procedural documentation behind their structural heart device. This is a high-impact individual contributor role at the center of Clinical, R&D, Regulatory, Therapy Development, and Quality—where procedural insight, clinical data, and engineering intent come together to support submissions and shape the future of the technology. You’ll translate what actually happens in the cath lab into clear, defensible, submission-ready narratives—and you’ll be trusted to do it with rigor, independence, and judgment.
Your role with the company:
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Become a deep subject-matter expert on the TMVR system, procedures, and supporting evidence
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Support clinical cases by ensuring devices are prepared, functional, and troubleshot in real time when needed
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Analyze procedural learnings, clinical data, engineering insights, imaging, and literature to drive continuous refinement of scientific documentation
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Develop structured, high-quality technical content grounded in anatomical, procedural, and medical parameters
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Identify gaps, inconsistencies, or weak assumptions—and proactively drive information-gathering efforts to close them
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Own documentation from concept to final submission: planning, drafting, cross-functional alignment, reviews, version control, and finalization
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Serve as the central integrator of scientific and procedural insights across Clinical, R&D, Regulatory, Therapy Development, and Quality
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Lead structured SME review cycles to ensure clarity, accuracy, traceability, and scientific rigor
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Master’s degree in a scientific, biomedical, engineering, or related discipline
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7+ years in Clinical Science, Clinical Affairs, Medical Writing, or Clinical Research within medical devices
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Direct experience with structural heart, TMVR/TAVR, or other transcatheter systems
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Hands-on experience reviewing clinical data, procedural imaging, and physician feedback to inform documentation
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Strong familiarity with pivotal clinical trial design and execution
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Exceptional technical writing skills with a sharp eye for detail and accuracy
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Ability to synthesize complex, cross-functional inputs into clear, scientifically defensible narratives
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Proven ownership mindset—comfortable driving work independently, end to end
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Thrives in fast-moving, evolving environments without needing excessive direction
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Not looking to manage a team—looking to own meaningful, high-impact work
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Relentless about clarity, precision, and scientific integrity
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Curious, resourceful, and unafraid to dig until the full story is understood
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Brings structure to ambiguity and calm to shifting priorities
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Enjoys partnering across disciplines to build shared understanding and alignment
Why This Role Stands Out:
This isn’t a support role—and it isn’t just writing. Your work will directly influence regulatory submissions, clinical strategy, and how the technology is understood and defended. If you want visibility, ownership, and real impact in structural heart, this role delivers.