Manager Clinical Affairs
Core
Lead clinical study programs and evidence-generation strategies for an innovative implantable neuromodulation therapy treating chronic neurological conditions.
Role type
Manager, Clinical Affairs
Builds
Clinical evidence packages for regulatory approval and market access
Domain
Medical devices / Neurostimulation
Required skills
Clinical trial leadership, Regulatory strategy, Clinical quality systems, Stakeholder coordination, Study documentation, Health-economic analysis
Preferred skills
Neurostimulation industry experience, FDA regulatory experience, Master's degree or PhD
Technologies
Electronic data capture systems, Web-based clinical trial management tools
Responsibilities
Plan and manage clinical studies, Define program timelines and milestones, Oversee clinical quality and compliance, Coordinate internal and external stakeholders, Develop clinical study documentation, Support clinical affairs strategy
Seniority
Manager, hands-on leadership