Sr Clinical Scientist
$150,000–$180,000 year
RemoteUnited States
Job Summary
Proactively manage project-level scientific aspects of clinical research, including study design, analysis, and evidence dissemination. Lead development of clinical study protocols for prospective trials and real-world evidence, while driving analysis and interpretation of prospective data with biostatistics teams. Support clinical science functions in developing evidence strategies and lead dissemination through scientific writing, conference abstracts, and peer-reviewed articles. Collaborate with internal and external stakeholders to ensure robustness of findings and alignment with strategic goals, including cross-functional support for health economics and outcomes research. Periodically provide updates on study progress and partner with operations to mitigate risks and ensure adherence to regulatory requirements.
Required Qualifications
- Advanced Degree in Biomedical Science or Health-related field
- Ten or more years of clinical science or clinical development experience in medical device or related industries or in high-performing academic medical centers/universities, or academic or commercial research organizations (AROs/CROs)
- knowledge of clinical research operations including GCP and ISO 14155
- Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, cardiology or a related field
- Cardiovascular experience
- Experience in observational study design and execution (health services and outcomes research) as well as clinical trial design
- Strong understanding of causal inference
- Working knowledge of metrics associated with diagnostic testing accuracy (i.e., Sensitivity, Specificity, PPV, NPV)
- A demonstrated working knowledge of GCP, FDA and EU regulations regarding medical devices and SaMD
- Substantive experience with study design including clinical trials and observational designs
- Understanding of basic and intermediate biostatistics
- Understanding of commonly applied biostatistical approaches and causal inference
- Strong writing skills and experience in writing clinical study reports, conference abstracts, and manuscripts for peer-reviewed journals
- Experience with US and EU clinical-regulatory documentation
- Demonstrated ability to collaborate effectively with cross-functional teams, including product management, regulatory affairs, and R&D
- Experience in program management and project oversight, including high visibility projects
- Read, write and speak fluent English
- ability to present information to a variety of audiences
- Willingness and ability to travel domestically and internationally
- less than 30 % of work time
Desired Qualifications
- MD, PhD
- experience in writing clinical study reports, conference abstracts, and manuscripts for peer-reviewed journals; experience with US and EU clinical-regulatory documentation is preferred (e.g., 510(k), IDE, PMA, and CER)
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