Job Description
Job DescriptionPosition Summary
We are seeking a highly analytical and self-driven Senior Clinical Scientist to lead the development of high-quality scientific and technical documentation supporting our TMVR (Transcatheter Mitral Valve Replacement) system. This individual contributor role partners cross-functionally with Clinical, R&D, Regulatory, and Quality teams to transform complex clinical, engineering, and procedural insights into clear, accurate, and submission-ready materials.
This role is ideal for someone who thrives in a fast-paced environment, enjoys owning work end-to-end, and is passionate about advancing innovative structural heart technologies.
Key ResponsibilitiesScientific Leadership & Analysis
- Develop deep subject matter expertise in company products and TMVR procedures
- Analyze clinical data, procedural learnings, engineering inputs, and scientific literature to support product development and continuous improvement
- Interpret anatomical, procedural, and clinical variables to generate scientifically sound insights
Technical Documentation & Medical Writing
- Lead the creation of clear, structured, and scientifically rigorous documentation for regulatory submissions and internal use
- Translate complex procedural and clinical information into accurate, accessible content
- Ensure all materials meet high standards for clarity, consistency, and scientific defensibility
Cross-Functional Collaboration
- Act as a central hub for collecting and synthesizing insights from Clinical, R&D, Regulatory, Quality, and Therapy Development teams
- Facilitate structured review cycles with subject matter experts to ensure alignment and accuracy
- Partner with stakeholders to validate assumptions and close knowledge gaps
Clinical & Procedural Support
- Support clinical cases by preparing devices and troubleshooting procedural issues as needed
- Incorporate physician feedback, imaging data, and real-world insights into documentation and analysis
Process Ownership
- Own end-to-end documentation workflows, including planning, drafting, review cycles, version control, and finalization
- Identify gaps or inconsistencies in data and proactively drive efforts to resolve them
QualificationsEducation
- Master’s degree in Biomedical Engineering, Life Sciences, or a related field
Experience
- 7+ years of experience in Clinical Science, Clinical Affairs, Medical Writing, or Clinical Research within medical devices or cardiovascular space
- Experience with structural heart technologies (TMVR, TAVR, or other transcatheter systems preferred)
- Experience analyzing clinical data, procedural imaging, and physician feedback
Knowledge, Skills & Abilities
- Strong understanding of clinical trial design and execution
- Exceptional technical writing and communication skills
- Ability to synthesize complex data into clear, cohesive, and scientifically sound narratives
- Proven ability to independently manage projects from concept to completion
- Detail-oriented with a strong commitment to accuracy and scientific rigor
- Comfortable working in fast-paced, evolving, cross-functional environments
- Resourceful, curious, and proactive in identifying and solving problems
- Strong collaboration skills with the ability to build alignment across disciplines
What Success Looks Like
- High-quality, submission-ready documentation delivered on time
- Clear, actionable insights derived from complex clinical and procedural data
- Strong cross-functional alignment and trust as a scientific partner
- Continuous improvement in documentation quality and knowledge integration
Salary Description
$110,000 TO $150,000
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