Development

Job Description

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

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