Director Clinical Affairs

Mobia Medical • Fridley, MN

2d

About The Position

The Director, Clinical Affairs is a key leadership role responsible for driving the clinical strategy and execution that supports the continued growth and evolution of our therapy. This individual will lead the planning, execution, and oversight of clinical studies, including post-market research, investigator-initiated studies, and future indication expansion efforts.
As a cross-functional leader, you will partner closely with Regulatory, Medical Affairs, R&D, Quality, and Commercial teams to ensure clinical evidence supports product adoption, lifecycle management, and long-term business objectives.

Requirements

• Advanced degree in life sciences, clinical research, engineering, nursing, or related field (PhD, MD, MS, or equivalent)
• 10+ years of clinical research experience, including at least 5 years in a leadership role within medical devices or neuromodulation
• Proven experience leading multicenter clinical studies (pivotal and/or post-market)
• Strong knowledge of FDA regulations, GCP, ISO 14155, and global clinical research standards
• Demonstrated success managing CROs and external vendors

Nice To Haves

• Experience in neuromodulation, neurorehabilitation, stroke, or implantable medical devices
• Background supporting post-approval studies or label expansion
• Experience working in a growth-stage or entrepreneurial medical device environment

Responsibilities

• Lead clinical strategy and innovation
• Design and oversee clinical programs including new indication studies, post-market studies, registries, and real-world evidence initiatives
• Provide strategic input into future clinical development plans and feasibility assessments
• Drive study execution and operational excellence
• Oversee all phases of clinical studies, including protocol development, site selection, monitoring, data integrity, and study close-out
• Manage CROs, vendors, and consultants to ensure studies are delivered on time, within budget, and in compliance with regulatory requirements
• Ensure adherence to GCP, ISO 14155, FDA, and international clinical research standards
• Partner cross-functionally to maximize impact
• Collaborate with Regulatory Affairs on submissions, regulatory responses, and post-approval commitments
• Work with Medical Affairs and Commercial teams to translate clinical data into scientific messaging and education
• Partner with R&D to provide clinical insights that inform product enhancements and next-generation technologies
• Engage externally and shape the scientific narrative
• Build and maintain strong relationships with key opinion leaders (KOLs) and investigators
• Contribute to scientific publications, abstracts, and conference presentations
• Build and lead a high-performing team
• Develop, mentor, and grow a clinical team aligned with company growth
• Manage clinical budgets, timelines, and resource planning
• Establish scalable clinical processes and infrastructure

Benefits

• Mobia Medical 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 18 paid company holidays per year.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree