Senior Clinical Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Take an active role in overseeing the scientific dimensions of clinical research projects, which encompasses study design, analysis, and the dissemination of evidence.

• Assist the Clinical Science team in formulating strategies for clinical evidence development.

• Collaborate closely with both internal (including product management, regulatory, R&D, data management, and biostatistics) and external (clinical thought leaders and subject matter experts) stakeholders to ensure the integrity of clinical findings and alignment of evidence with iRhythm's strategic objectives.

• Spearhead the creation of clinical study designs and protocols for prospective trials aimed at market clearance and post-market clinical evidence.

• Formulate analysis plans and study protocols for targeted analyses of existing datasets, which involve prior device registrations and other real-world evidence.

• In partnership with data management and biostatistics, drive the analysis and interpretation of prospective clinical data and real-world evidence.

• Lead the dissemination of evidence for clinical applications and product initiatives through a) scientific writing, including the drafting and submission of conference abstracts and peer-reviewed journal articles, b) development of posters and presentations for scientific meetings, and c) collaboration with internal and external co-authors via steering committees, investigator meetings, and one-on-one discussions.

• Provide cross-functional support for health economics and outcomes research (HEOR) and regulatory teams, including the preparation of US and Global regulatory-clinical documentation (e.g., CSRs, CERs).

• Engage in the evaluation of external investigator-initiated research proposals for scientific validity and alignment with iRhythm's goals.

• Regularly update stakeholders on study progress in relation to the project plan.

• Collaborate with clinical research operations to ensure timely clinical study execution, risk mitigation, and compliance with quality standards, standard operating procedures (SOPs), and regulatory requirements.

⛳️ Requirements

• An advanced degree in Biomedical Science or a health-related field is required (MD or PhD preferred).

• A minimum of ten years of experience in clinical science or clinical development within the medical device industry or related sectors, including high-performing academic medical centers/universities or academic/commercial research organizations (AROs/CROs).

• Familiarity with clinical research operations, including GCP and ISO 14155.

• Clinical research experience in heart rhythm disorders, atrial fibrillation, cardiac electrophysiology, cardiology, or a related field is essential. Cardiovascular experience is highly preferred.

• Proven expertise in observational study design and execution (health services and outcomes research), as well as clinical trial design.

• Strong understanding of causal inference methodologies.

• Proficient knowledge of metrics related to diagnostic testing accuracy (e.g., Sensitivity, Specificity, PPV, NPV).

• A solid working knowledge of GCP, FDA, and EU regulations concerning medical devices and Software as a Medical Device (SaMD).

• Extensive experience with study design, including clinical trials and observational studies.

• A foundational understanding of basic and intermediate biostatistics. While complex statistical analysis is not expected, familiarity with commonly applied biostatistical approaches and causal inference is critical.

• Exceptional writing skills and experience in drafting clinical study reports, conference abstracts, and manuscripts for peer-reviewed journals; familiarity with US and EU clinical-regulatory documentation is preferred (e.g., 510(k), IDE, PMA, and CER).

• Proven ability to collaborate effectively with cross-functional teams, including product management, regulatory affairs, and R&D.

• Experience in program management and project oversight, particularly with high visibility projects.

• Ability to read, write, and speak fluent English; capable of presenting information to diverse audiences.

• Willingness and ability to travel domestically and internationally is required, with an expectation that travel will be less than 30% of work time.

🏝️ Benefits

• Excellent benefits package including medical, dental, and vision insurance (effective from your first day).

• Employer contributions to health savings accounts (when enrolled in a high deductible medical plan).

• Pre-taxed benefits through a cafeteria plan (FSA, dependent care FSA, commute reimbursement accounts).

• Travel reimbursement for medical care.

• Noncontributory basic life insurance & short/long-term disability coverage.

• 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) plan with company match.

• Employee Stock Purchase Plan.

• Discount on pet insurance.

• Unlimited access to LinkedIn Learning classes.