MicroTransponder
MicroTransponder, Inc. is dedicated to transforming the lives of stroke survivors through its innovative neurostimulation technology. The company's flagship product, the FDA-approved Vivistim® Paired VNS™ System, enhances stroke rehabilitation by pairing vagus nerve stimulation (VNS) with physical and occupational therapy. This approach leverages the brain's neuroplasticity to improve upper limb function, offering new hope to those with chronic arm and hand impairments following an ischemic stroke.
By integrating this therapy into rehabilitation programs, MicroTransponder aims to help stroke survivors regain independence in daily activities and enhance their quality of life. The company's commitment to advancing stroke recovery is evident in its ongoing research and collaboration with healthcare providers to make this therapy accessible to more patients.
About the role
The Director, Clinical will provide strategic and operational leadership for clinical studies supporting the Vivistim® Paired VNS Therapy System. This role is responsible for the planning, execution, and oversight of clinical evidence generation, including post-market studies, investigator-initiated research, and indication expansion studies. The Director, Clinical will serve as a key cross-functional leader, partnering closely with Regulatory, Medical Affairs, R&D, Quality, and Commercial teams to ensure clinical activities support product adoption, lifecycle management, and long-term business objectives. What you'll do
Clinical Strategy & Leadership 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. Study Planning & Execution 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. Cross-Functional Collaboration 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. Scientific & External Engagement Support key opinion leader (KOL) engagement and investigator relationships. Contribute to abstracts, manuscripts, and presentations at scientific and medical conferences. People & Budget Management 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. Qualifications
Advanced degree in life sciences, clinical research, engineering, nursing, or related field (PhD, MD, MS, or equivalent). 10+ years of clinical research experience, with at least 5 years in a leadership role within medical devices or neuromodulation. Demonstrated experience leading multicenter clinical studies, preferably pivotal trials or post‑market trials. Strong knowledge of FDA, GCP, ISO 14155, and clinical research regulations. Proven ability to manage CROs and external vendors effectively. Experience with neuromodulation, neurorehabilitation, stroke, or implantable medical devices. Prior experience supporting post‑approval studies or label expansion. Experience working in a growth‑stage or entrepreneurial medical device company. Strong scientific writing and presentation skills. Equal Opportunity Employer
MicroTransponder, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. MicroTransponder provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 15 paid company holidays per year.
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The Director, Clinical will provide strategic and operational leadership for clinical studies supporting the Vivistim® Paired VNS Therapy System. This role is responsible for the planning, execution, and oversight of clinical evidence generation, including post-market studies, investigator-initiated research, and indication expansion studies. The Director, Clinical will serve as a key cross-functional leader, partnering closely with Regulatory, Medical Affairs, R&D, Quality, and Commercial teams to ensure clinical activities support product adoption, lifecycle management, and long-term business objectives. What you'll do
Clinical Strategy & Leadership 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. Study Planning & Execution 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. Cross-Functional Collaboration 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. Scientific & External Engagement Support key opinion leader (KOL) engagement and investigator relationships. Contribute to abstracts, manuscripts, and presentations at scientific and medical conferences. People & Budget Management 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. Qualifications
Advanced degree in life sciences, clinical research, engineering, nursing, or related field (PhD, MD, MS, or equivalent). 10+ years of clinical research experience, with at least 5 years in a leadership role within medical devices or neuromodulation. Demonstrated experience leading multicenter clinical studies, preferably pivotal trials or post‑market trials. Strong knowledge of FDA, GCP, ISO 14155, and clinical research regulations. Proven ability to manage CROs and external vendors effectively. Experience with neuromodulation, neurorehabilitation, stroke, or implantable medical devices. Prior experience supporting post‑approval studies or label expansion. Experience working in a growth‑stage or entrepreneurial medical device company. Strong scientific writing and presentation skills. Equal Opportunity Employer
MicroTransponder, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. MicroTransponder provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 15 paid company holidays per year.
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