Vice President, Clinical Development, Evidence, and Strategy

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

Vice President, Clinical Development, Evidence, and Strategy

Position Summary

The Vice President of Clinical Development, Evidence, and Strategy will be responsible for leading the company's overall global clinical strategy, clinical positioning, differentiation, and the pre- and postmarket evidence generation portfolio; and for architecting how evidence informs product value, regulatory strategy, and competitive positioning. The leader will be critical member of the group that determines the clinical roadmap of the business across hardware, software, AI, and services. This leader will steward the company's global clinical research, clinical development (including AI products), real-world evidence, and commercial clinical research operations, uniting scientific, statistical, and operational capabilities into a cohesive enterprise that delivers clinical differentiation and commercial impact.

Reporting to the Chief Medical & Scientific Officer, this leader will manage the Advanced Technologies team, and will set the strategic vision for the product and service portfolio and roadmap including discovery work, upstream (emerging) technologies, and launched and in-market products. This includes defining and validating the clinical use cases, which are triangulated across clinical need, technical feasibility, and commercial opportunity. The leader will define and execute on how clinical evidence is generated, integrated, and communicated from early first-in-human studies and regulatory trials to post-market evidence, payer-focused outcomes research, and real-world data programs. They will define how evidence shapes product value propositions, informs clinical and regulatory pathways, differentiates the portfolio in competitive markets, and drives market access, adoption, and guideline inclusion. The executive will be responsible for management of pivotal clinical studies, site-based clinical studies, real-world evidence and comparative effectiveness strategies, the investigator-initiated research program, academic research partnerships, clinical support of regulatory submissions; ensuring high-quality execution, scientific rigor, and alignment with business and regulatory objectives. A key focus will be AI software medical devices.

This leader will bring deep clinical trial expertise in cardiology, cardiac arrhythmias, and artificial intelligence and the strategic vision to translate evidence into market leadership, including experience in pivotal FDA studies, combined with scientific acumen and proven ability to generate real-world data insights that advance product claims, market access, and patient outcomes.

Key Responsibilities

Clinical Strategy & Evidence Architecture

• Responsible and accountable to lead the company's overarching clinical strategy for new and existing products, integrating regulatory, clinical, and commercial considerations into a unified evidence roadmap.
• Define scientific priorities and ensure alignment across clinical needs, commercial opportunity, and corporate goals.
• Architect the clinical narrative that underpins product differentiation - shaping how evidence supports indications, labeling, reimbursement, and clinical adoption.
• Translate corporate strategy and innovation priorities into clinical development and evidence-generation strategies that accelerate product approval, drive market access, and influence clinical practice -across hardware, software, AI, and clinical services.
• Partner with Product Management, Advanced Technologies, Medical Safety & Clinical Oversight, R&D, and Health Economics & Value Insights, to align product roadmaps with clinical pathways, ensuring that evidence needs are embedded from concept through commercialization.
• Anticipate evolving clinical, regulatory, and payer landscapes and design evidence strategies that position the company as a leader in cardiac diagnostics and digital health.

Product Clinical Development Function

• Responsible and accountable to define and validate the clinical use cases for future products, based across unmet clinical needs and gaps, but defining hardware, software, and AI features, functions and capabilities required to serve these clinical use cases in relevant markets.

Evidence Generation Function

• Lead the design and execution of pivotal FDA and global regulatory studies, ensuring methodological rigor, operational excellence, and strategic alignment with labeling and market goals.
• Oversee the development and execution of first-in-human and early feasibility studies that inform design validation, clinical utility, and value demonstration.
• Integrate real-world evidence and comparative effectiveness research into regulatory submissions, label expansion strategies, and payer dossiers, often in close collaboration with the Health Economics and Value Insights Team
• Guide investigator-initiated research programs and academic collaborations that extend the company's scientific leadership and evidence base.

Commercial Research Services Function

• Own the strategic development and execution our commercial, revenue-generating Research as a Service (RaaS) program, positioning the company as a preferred research partner for medical device, pharmaceutical, and academic studies that leverage its technologies.

Commercial & Strategic Enablement

• Partner with commercial and market access teams to define the clinical evidence needed for reimbursement, guideline inclusion, and health economic value demonstration.
• Ensure that clinical strategy informs and strengthens brand positioning, competitive differentiation, and market entry strategies.

Functional Leadership & Organizational Development

• Lead multidisciplinary teams spanning:
  • Clinical Development
  • Science
  • Biostatistics and Data Management
  • Clinical Data Warehouse and Data Engineering
  • Clinical Research Operations and Commercial Research Services
• Build scalable infrastructure and processes for evidence generation, data curation, analysis, and dissemination.
• Collaborate closely with the System Engineering and Artificial Intelligence teams on product vision, definition, and AI development and evidence generation strategies.
• Foster tight cross-functional collaboration with Regulatory Affairs, Medical Safety, Advanced Technologies, Product Development, Medical Affairs, and the Global Value, Access, and Population Health (GVAP) team to ensure coordinated clinical and economic evidence strategies.
• Provide statistical and clinical input to regulatory submissions, quality investigations, and
• Foster a culture of scientific excellence, extreme rigor and transparency, collaboration, rapid execution, and accountability.

External Leadership & Advocacy

• Serve as one of the organization's clinical voices for the company in interactions with regulatory agencies (FDA, EMA, PMDA, etc.), professional societies, payers, and academic partners.
• Shape the company's external presence through publications, conference leadership, and strategic partnerships.
• Build advocacy among clinical opinion leaders and contribute to the evidence base that drives changes in practice and standards of care.

Qualifications

• M.D. or equivalent advanced degree in medicine
• Additional research degree (M.S. or Ph.D.) is highly desirable but may be supplanted with extensive academic or commercial experience in clinical research, biostatistics, epidemiology, artificial intelligence, or related discipline
• 12+ years of leadership experience in clinical research and scientific functions within academic, health system, medical device, diagnostics, or pharma/biotech industries.
• Proven track record of leading pivotal FDA studies (IDE, PMA, or NDA/BLA submissions) from design through approval
• Experience as the Principal Investigator for formative, user experience, human factors, and design validation, premarket, and post-market studies across regulated hardware, software, AI products.
• Demonstrated expertise in clinical trial design and strong familiarity in sample size estimation, and statistical methodology required for U.S. and international regulatory standards for Class II diagnostic devices
• Demonstrated success in translating clinical evidence into regulatory approvals, payer coverage, and commercial adoption
• Strong background in clinical strategy, evidence architecture, real-world evidence generation, health outcomes, or epidemiology
• Experience managing multi-disciplinary teams (science, data, clinical research) and scaling organizations during growth.
• Excellent communication, leadership, and collaboration skills; ability to influence at executive and board levels.

Reporting & Relationships

• Reports to: Chief Medical & Scientific Officer (EVP, Product Innovation & Management)
• Direct reports: Head of Science (IC), Head of Biostatistics/Data Management team, Data Engineer, Electronic Data Capture Lead (dotted or direct, depending on final structure).
• Close collaboration with: CMO/CSO, Chief Medical Safety Officer, Regulatory Affairs and Quality Assurance, Product Management, R&D (Product Development and Systems Architecture), Advanced Technologies, Medical Affairs, GVAP.

Impact & Success Metrics

• A unified, forward-looking clinical strategy across the product roadmap that drives product feature definitions, regulatory approvals, market access, and clinical adoption.
• Evidence portfolios that expand indications, strengthen labeling, and support payer and guideline inclusion.
• On-time delivery of pivotal and post-market evidence programs aligned with strategic business objectives.
• Growth and commercial success of Research as a Service (RaaS) business.
• Strong external advocacy and recognition of the company's evidence leadership in cardiovascular diagnostics and digital health.
• Recruitment, development, and retention of world-class clinical and scientific talent.

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121