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