Director of Evidence Generation

Job Offer: Director of Evidence Generation. Main Mission: Design and provide the real-world clinical evidence required to obtain regulatory approval, reimbursement, and market adoption for software as a medical device (SaMD). This role sits at the intersection of clinical development, regulatory affairs, 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, interventional trials); Conduct observational studies (cohort studies, registries); Utilize real-world data studies using device-generated data and claims data; Ensure appropriate methodologies for digital health (adaptive designs, external control arms). Real-World Evidence & Post-Market Strategy: Align evidence strategy with regulatory pathways and decide on study designs & endpoints; Develop post-market evidence plans: PMCF, AI lifecycle management; Leverage digital data streams (product usage data, registries, digital biomarkers). HEOR & Value Demonstration: Ensure evidence reporting; Collaborate with technology assessment agencies.