Irhythmtech

Irhythmtech

Vice President, Clinical Development, Evidence, and Strategy

Remote - US · Exec

Sponsorship not specified$266k-$346kDetected 30 days ago
AlgorithmsData AnalysisData EngineeringProduct ManagementProduct StrategyClinical TrialsClinical ResearchPatient CareFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationBiostatisticsEpidemiologyRegulatory Affairs

About the role

  • Vice President, Clinical Development, Evidence, and Strategy
  • The leader will be critical member of the group that determines the clinical roadmap of the business across hardware, software, AI, and services.
  • This includes defining and validating the clinical use cases, which are triangulated across clinical need, technical feasibility, and commercial opportunity.

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.
  • 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.
  • 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.
  • Every day, we collaborate, create, and constantly reimagine what's possible.
  • Build scalable infrastructure and processes for evidence generation, data curation, analysis, and dissemination.

Requirements

  • M.D. or equivalent advanced degree in medicine
  • 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
  • Experience managing multi-disciplinary teams (science, data, clinical research) and scaling organizations during growth.
  • ability to influence at executive and board levels.
  • 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 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
  • Excellent communication, leadership, and collaboration skills
  • 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).

Compensation

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

Benefits

  • Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career
  • Collaborate closely with the System Engineering and Artificial Intelligence teams on product vision, definition, and AI development and evidence generation strategies.
  • Architect the clinical narrative that underpins product differentiation - shaping how evidence supports indications, labeling, reimbursement, and clinical adoption.
  • Anticipate evolving clinical, regulatory, and payer landscapes and design evidence strategies that position the company as a leader in cardiac diagnostics and digital health.

Company info

  • Guide investigator-initiated research programs and academic collaborations that extend the company's scientific leadership and evidence base.
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