Patient and Device Safety Director, Digital Science - Evinova
Core
Set scientific direction and oversee the design, development, and safety of digital solutions supporting clinical development, ensuring they are scientifically defensible, safe for patients, and compliant with regulatory frameworks.
Role type
Senior IC Digital Science Director (Patient and Device Safety)
Builds
Digital health solutions (RPM modules, dosing diaries, assessment tools) for clinical trials and patient care
Domain
Life sciences / Digital health / Clinical research
Deliverable
production ML models
Required skills
Scientific oversight of digital health solutions, patient safety risk management, regulatory strategy (EU MDR, FDA SaMD), clinical validity assessment, user-centred design, evidence generation methodology
Preferred skills
Experience with AI-enabled solutions, stakeholder management in R&D governance
Technologies
Digital health platforms, remote monitoring systems, clinical trial software
Responsibilities
Own innovation roadmap for patient-facing digital solutions, establish risk management frameworks for new functionalities, co-own regulatory strategy for software and device classification, design evidence generation studies for content validity, define intended use and value propositions for proposed solutions, oversee post-deployment surveillance of digital solutions
Seniority
Senior, hands-on IC