Sr Clinical Scientist

El Camino Health; United States; Remote; USD 150,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401(k) plan with company match

Employee stock purchase plan

Paid parental leave

Job summary

iRhythm Technologies, Inc. seeks a Senior Clinical Research Scientist to lead the scientific aspects of clinical research within its Scientific Affairs group. You will design studies, analyze data, and craft medical writing to support product innovation and evidence dissemination.

Responsibilities include developing study protocols, disseminating results via abstracts and publications, and aligning with regulatory requirements. Domestic and international collaboration and travel may be required.

Qualifications

• Advanced degree in biomedical science or a related health field (MD or PhD preferred).
• 10+ years of clinical science or clinical development experience in medical devices, academic centers, or CRO settings.
• Knowledge of GCP, ISO 14155, and medical device regulatory environments (FDA, EU, SaMD).
• Fluent in written and spoken English; travel up to 30% as needed.

Responsibilities

• Lead scientific aspects of clinical research projects, including study design, analysis, and dissemination of evidence.
• Support evidence strategies within Clinical Science function.
• Collaborate with product management, regulatory, R&D, data management, and biostatistics to ensure robust findings.

Skills

GCP knowledge

Regulatory knowledge

Study design

Biostatistics

Scientific writing

Education

MD or PhD preferred

Job description

About This Role

iRhythm is looking for an experienced Senior Clinical Research Scientist to lead scientific aspects of clinical research within its Scientific Affairs organization. The role focuses on study design, analysis, and medical/scientific writing to support product innovation and evidence dissemination.

Key Responsibilities

• Proactively lead the scientific aspects of clinical research projects, including study design, analysis, and evidence dissemination.
• Support the Clinical Science function in developing evidence strategies.
• Collaborate with internal stakeholders (product management, regulatory, R&D, data management, biostatistics) and external experts to ensure robust clinical findings and alignment with strategic goals.
• Lead development of study protocols for prospective trials to support market clearance and post‑market evidence.
• Create analysis plans and protocols for targeted analysis of existing datasets, including prior device registrations and real‑world evidence.
• Work with data management and biostatistics to drive analysis and interpretation of prospective data and real‑world evidence.
• Lead evidence dissemination through scientific writing, including conference abstracts, peer‑reviewed journal articles, posters, slides, and collaboration with co‑authors.
• Provide cross‑functional support for HEOR and regulatory teams, including US and global regulatory documentation (CSRs, CERs).
• Review external investigator‑initiated research proposals for scientific merit and alignment with iRhythm objectives.
• Provide regular updates on study progress relative to the project plan.
• Partner with clinical research operations to ensure timely execution, risk mitigation, and adherence to quality standards, SOPs, and regulatory requirements.

Qualifications

• Advanced degree in biomedical science or a related health field (MD or PhD preferred).
• 10+ years of clinical science or clinical development experience in medical devices, high‑performing academic centers, or ARO/CRO settings.
• Knowledge of GCP, ISO 14155, and medical device regulatory environments (FDA, EU, SaMD).
• Experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, or related cardiology fields; cardiovascular experience strongly preferred.
• Proficiency in observational and interventional study design and execution.
• Strong understanding of causal inference and diagnostic accuracy metrics (sensitivity, specificity, PPV, NPV).
• Basic to intermediate biostatistics skills and familiarity with common biostatistical approaches.
• Excellent scientific writing skills; experience with clinical study reports, abstracts, manuscripts, and US/EU regulatory documentation (510(k), IDE, PMA, CER).
• Demonstrated ability to collaborate across cross‑functional teams (product, regulatory, R&D).
• Experience in program management and oversight of high‑visibility projects.
• Fluent in written and spoken English; ability to present to diverse audiences.
• Willingness to travel domestically and internationally (≤30% of work time).
• Remote work within the United States with reliable internet connection and dedicated workspace.

Benefits

• Competitive base salary ($150,000‑$180,000) plus performance incentives.
• Comprehensive medical, dental, and vision coverage starting on day one.
• Health savings account with employer contributions and cafeteria plan benefits.
• Travel reimbursement for medical care and personal trips.
• Paid parental leave, paid holidays, and PTO.
• 401(k) plan with company match.
• Employee Stock Purchase Plan.
• Pet insurance discount, unlimited LinkedIn Learning courses, and additional wellness resources.

Equal Opportunity

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We consider all qualified applicants, including those with arrest and conviction records, in accordance with applicable laws. We provide reasonable accommodations for qualified individuals with disabilities during the application process.