Sr Clinical Scientist

iRhythm is currently seeking an experienced and motivated Senior Clinical Research Scientist to provide leadership in clinical study design, analysis, and medical/scientific writing as part of its Scientific Affairs organization. This is a unique opportunity to work as part of a highly collaborative team comprised of medical and scientific leaders tasked with driving iRhythm’s product innovation, development of clinical strategies, and evidence dissemination. The Senior Clinical Research Scientist is responsible for the leading scientific aspects of clinical research for assigned project(s) and will work closely with Clinical Research Operations, Biostatistics and Data Management, other iRhythm functions and external partners to deliver impactful clinical evidence. The Senior Clinical Research Scientist, in concert with the clinical director, is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints. This is a fully remote position, allowing you to work from anywhere within the United States. Candidates much have a reliable internet connection and dedicated workspace to ensure productivity.

Essential Duties and Responsibilities include:

• 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 (product management, regulatory, R&D, data management and biostatistics) and external (clinical thought leaders and other subject matter experts) stakeholders to ensure robustness of clinical findings and alignment of evidence to iRhythm strategic goals
• Lead development of clinical study design and study protocols for prospective trials in support of market clearance and post-market clinical evidence.
• Develop analysis plans and study protocols for targeted analysis of existing datasets, including prior device registrations and other real-world evidence
• With data management and biostatistics, drive analysis and interpretation of prospective clinical data and real-world evidence
• Lead evidence dissemination for clinical applications and product programs through a)scientific writing including drafting and submission of conference abstracts and peer-reviewed journal articles, b)development of poster and slides for scientific meetings, and c)collaboration with internal and external co-authors through steering committees, investigator meetings and 1-on-1 communication
• Cross-functional support of health economics and outcomes research (HEOR) and regulatory teams, including development of US and Global regulatory-clinical documentation (e.g., CSRs, CERs)
• Participate in review of external investigator-initiated research proposals for scientific merit and alignment with iRhythm objectives
• Periodically provide updates on study progress, and with respect to project plan.  Partner with clinical research operations to ensure timeliness of clinical study execution, mitigation of project risks, and adherence to quality standards, standard operating procedures (SOPs) and regulatory requirements.