Evidence Generation Director

Job Opening: Clinical Real-World Evidence Specialist

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.

Main Activities:

• Clinical & Real-world Study Design

  • Design and oversee clinical trials (pragmatic trials, interventional)

  • Conduct observational studies (cohort studies, registries)

  • Utilize real-world data studies using device-generated data and claims data

  • Ensure fit-for-purpose methodologies for digital health (adaptive designs, external control arms)

• Real World Evidence & Post Market Strategy

  • Align evidence strategy with regulatory pathways and decide study designs & endpoints

  • Develop post-market evidence plans: PMCF, AI life cycle management

  • Leverage digital data streams (product usage data, registries, digital biomarkers)

• HEOR & Value Demonstration

  • Ensure evidence reports

  • Collaborate with HTA bodies

• Cross-Functional Leadership

  • Act as a strategic integrator across functions:

    • Clinical development

    • Biostatistics

    • Data science / AI

    • Medical affairs

    • Regulatory affairs

    • Market access/commercial

• External Partnerships

  • Collaborate with hospital networks, academic centers, CROs, and data centers/registries

Key Competencies

• Technical

  • Clinical epidemiology, biostatistics

  • RWE methodology

  • Regulatory frameworks (FDA, EU MDR, IMDRF SaMD guidance)

  • Digital health / AI validation frameworks

• Strategic

  • Life cycle thinking

  • Understanding payers' expectations

  • Evidence planning aligned to business goals

• Operational

  • Study execution oversight

  • Vendor management

  • Budget & Timeline control

• Leadership

  • Translating complex data into decisions

  • Storytelling with evidence

  • Influencing skills

  • Excellent communication and leadership abilities

  • Foster a culture of innovation

Typical Deliverables

• Integrated Evidence Plan/PM evidence plans

• Contribute to CEP/CER

• Study protocols

• HEOR Models

• Publications

Background

• MD, PharmD or PhD or equivalent (advanced Degree in life sciences)

• >10 years in Epidemiology, RWE, HEOR/medico economics

• Proven leadership in Pharma/biotech or CRO environment

• Previous experience in Medtech or Digital Health
  
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