Evidence Generation Director F/M

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)
• Utilize real-world data studies using device-generated data and claims data
• Real World Evidence & Post Market Strategy
• Align evidence strategy with regulatory pathways and decide study designs & endpoints
• HEOR & Value Demonstration
• Ensure evidence reports
• Collaborate with HTA bodies
• Cross-Functional Leadership
• Act as a strategic integrator across functions:
• Data science / AI
• Medical affairs
• Regulatory affairs
• Market access/commercial
• External Partnerships
• Collaborate with hospital networks, academic centers, CROs, and data centers/registries
• Technical
• 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
• Budget & Timeline control
• Leadership
• Storytelling with evidence
• Excellent communication and leadership abilities
• Foster a culture of innovation

Typical Deliverables

• Integrated Evidence Plan/PM evidence plans
• Contribute to CEP/CER
• Study protocols
• 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

Median Technologies is committed to cultural diversity, gender equality and the employment of disabled workers.