Zio by iRhythm
Senior Clinical Scientist
Location
United States
Posted
9 days ago
Salary
$150K - $180K / year
Seniority
Senior
Job Description
Senior Clinical Scientist
iRhythm Technologies, Inc.
• 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.
Job 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
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