Main Mission: To design and deliver the clinical real-world evidence needed to gain regulatory approval, reimbursement, and market adoption for software as a medical device. This role is at the intersection of clinical development, regulatory, real-world evidence, HEOR, and data science/digital health. The position reports to the VP of Clinical Development & Medical Affairs.
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Clinical & Real-world Study Design
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Design and oversee clinical trials (pragmatic trials, interventional)
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Conduct observational studies (cohort studies, registries)
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Utilize real-world data studies using device-generated data and claims data
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Ensure fit-for-purpose methodologies for digital health (adaptive designs, external control arms)
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Real World Evidence & Post Market Strategy
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Align evidence strategy with regulatory pathways and decide study designs & endpoints
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Develop post-market evidence plans: PMCF, AI life cycle management
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Leverage digital data streams (product usage data, registries, digital biomarkers)
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HEOR & Value Demonstration
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Ensure evidence reports
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Collaborate with HTA bodies
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Cross-Functional Leadership
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Act as a strategic integrator across functions:
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Clinical development
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Biostatistics
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Data science / AI
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Medical affairs
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Regulatory affairs
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Market access/commercial
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External Partnerships
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Collaborate with hospital networks, academic centers, CROs, and data centers/registries
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Technical
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Clinical epidemiology, biostatistics
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RWE methodology
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Regulatory frameworks (FDA, EU MDR, IMDRF SaMD guidance)
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Digital health / AI validation frameworks
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Strategic
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Life cycle thinking
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Understanding payers' expectations
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Evidence planning aligned to business goals
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Operational
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Study execution oversight
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Vendor management
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Budget & Timeline control
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Leadership
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Translating complex data into decisions
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Storytelling with evidence
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Influencing skills
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Excellent communication and leadership abilities
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Foster a culture of innovation
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Integrated Evidence Plan/PM evidence plans
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Contribute to CEP/CER
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Study protocols
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HEOR Models
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Publications
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MD, PharmD or PhD or equivalent (advanced Degree in life sciences)
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>10 years in Epidemiology, RWE, HEOR/medico economics
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Proven leadership in Pharma/biotech or CRO environment
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Previous experience in Medtech or Digital Health
Median Technologies is committed to cultural diversity, gender equality and the employment of disabled workers.
