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MicroTransponder · 1 day ago

Director, Clinical

Hybrid (Minneapolis, Minnesota, US)

Full-time

Hybrid

Director/Executive

10+ years exp

MicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The Director, Clinical will provide strategic and operational leadership for clinical studies supporting the Vivistim® Paired VNS Therapy System, overseeing clinical evidence generation and collaborating with cross-functional teams to ensure successful product adoption and long-term business objectives.

Health CareMedicalMedical DeviceNeuroscience

Responsibilities

Design and oversee new indication studies, post-market clinical studies, registries, and real-world evidence initiatives

Provide clinical leadership for new indication feasibility and future clinical development plans

Oversee all aspects of clinical study execution, including protocol development, site selection, monitoring, data integrity, and study close-out

Manage CROs, vendors, and clinical consultants to ensure studies are executed on time, within budget, and in compliance with regulations

Ensure adherence to GCP, ISO 14155, FDA, and applicable international regulatory requirements

Partner with Regulatory Affairs to support submissions, responses to regulatory inquiries, and post-approval commitments

Collaborate with Medical Affairs and Commercial teams to translate clinical data into scientific messaging and education

Work closely with R&D to provide clinical input on product enhancements and next-generation technologies

Support key opinion leader (KOL) engagement and investigator relationships

Contribute to abstracts, manuscripts, and presentations at scientific and medical conferences

Build, mentor, and lead a high-performing clinical team as the organization grows

Develop and manage clinical budgets, timelines, and resource plans

Establish scalable clinical processes and infrastructure appropriate for a growing medical device company

Qualification

Clinical research experienceLeadership in medical devicesFDA regulationsNeuromodulationScientific writing skillsBudget managementTeam managementCross-functional collaboration