Senior Clinical Scientist

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Technology

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• 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.

🎯 Requirements

• Advanced Degree in Biomedical Science or Health-related field required (MD, PhD preferred) • 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 strongly preferred. • 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. While not expected to perform complex statistics, and understanding of commonly applied biostatistical approaches and causal inference is critical. • 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 • Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be less than 30 % of work time.

🏖️ Benefits

• excellent benefits including medical, dental, and vision insurances (all of which start on your first day) • 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 • paid time off (PTO) • 401(k) (with company match) • an Employee Stock Purchase Plan • pet insurance discount • unlimited amount of Linked In Learning classes