Vice President, Clinical Development, Evidence, and Strategy

About the 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.

• Leading the company’s overarching clinical strategy for new and existing products, integrating regulatory, clinical, and commercial considerations into a unified evidence roadmap.
• Defining scientific priorities and ensuring alignment across clinical needs, commercial opportunity, and corporate goals.
• Architecting the clinical narrative that underpins product differentiation — shaping how evidence supports indications, labeling, reimbursement, and clinical adoption.
• Translating 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.
• Partnering 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.
• Anticipating evolving clinical, regulatory, and payer landscapes and designing evidence strategies that position the company as a leader in cardiac diagnostics and digital health.

Key Responsibilities

• Clinical Strategy & Evidence Architecture:
• 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:
• 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 of the company’s 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

Location

Remote - US