Sr. Clinical Scientist

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Requirements:

• Advanced Degree in Biomedical Science or Health-related field required (MD, PhD preferred).
• 7+ years of clinical science or clinical development experience in medical device or related industries.
• Clinical research experience in heart rhythm disorders, atrial fibrillation, or cardiology.
• Experience in observational study design and clinical trial design.
• Strong understanding of causal inference.
• Working knowledge of diagnostic testing metrics (Sensitivity, Specificity, etc.).
• Knowledge of GCP, FDA and EU regulations regarding medical devices.
• Experience with clinical trial and observational study design.
• Understanding of basic and intermediate biostatistics.
• Strong writing skills for clinical documentation.
• Ability to collaborate with cross-functional teams.
• Experience in program management and project oversight.
• Read, write and speak fluent English.
• Willingness to travel domestically and internationally (less than 30% work time).

Responsibilities:

• Proactively manage project-level scientific aspects of clinical research projects, including study design, analysis, and evidence dissemination.
• Support the Clinical Science function in development of clinical evidence strategies.
• Work closely with internal and external stakeholders to ensure robustness of clinical findings.
• Lead development of clinical study design and study protocols for prospective trials.
• Develop analysis plans and drive analysis and interpretation of clinical data.
• Lead evidence dissemination through scientific writing and collaborations.
• Support health economics and outcomes research and regulatory teams.
• Provide updates on study progress and ensure adherence to standards.