Vice President, Clinical Development, Evidence, and Strategy

iRhythm Technologies, Inc.

1d•Remote

About The Position

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.

Requirements

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.

Nice To Haves

Extensive academic or commercial experience in clinical research, biostatistics, epidemiology, artificial intelligence, or related discipline

Responsibilities

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.
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.
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.
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.
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.
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.
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.