Remote Senior Clinical Scientist

Summary

Join iRhythm in creating trusted solutions that detect, predict, and prevent disease. As a Senior Clinical Research Scientist, you will lead scientific aspects of clinical research projects, develop clinical evidence strategies, and collaborate with cross-functional teams.

Requirements

• Advanced Degree in Biomedical Science or Health-related field required
• 7+ 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)
• Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, cardiology or a related field
• 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
• 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 is preferred (e.g., 510(k), IDE, PMA, and CER)
• 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

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 (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

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Health savings account employer contributions (when enrolled in high deductible medical plan)
• Cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts)
• Travel reimbursement for medical care
• Noncontributory basic life insurance & short/ long term disability
• Emotional health support for you and your loved ones
• Legal / financial / identity theft/ pet and child referral assistance
• Paid parental leave
• Paid holidays
• Travel assistance for personal trips and PTO!