Director Clinical Affairs

Location:

Roodhouse

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Job Title:

Director, Clinical Affairs

Location:

USA (Flexible – preference for major neurovascular hubs)

Department:

Clinical Affairs

Reports to:

Vice President, Clinical Affairs

About Us

We are a rapidly growing medical device company pioneering advanced interventional neurovascular therapies for the treatment of complex cerebrovascular diseases, including ischemic stroke, aneurysms, and other neurovascular disorders. Our mission is to develop devices that transform patient outcomes and set new standards of care.

Position Summary

The Director of Clinical Affairs will be responsible for leading the planning, execution, and management of clinical programs that support regulatory submissions, product launches, and post-market data collection. This role requires strong leadership in clinical trial operations, investigator engagement, and cross-functional collaboration.

The ideal candidate will have direct experience running neurovascular or complex endovascular clinical studies and be comfortable operating in a high-growth, fast-paced environment.

Key Responsibilities

• Lead the design, planning, and execution of assigned clinical trials (feasibility, pivotal, and post-market) in accordance with regulatory and ethical standards.
• Manage day-to-day trial operations, including site selection, initiation, monitoring, data collection, and close-out.
• Partner with the VP of Clinical Affairs to develop global clinical strategies and timelines.
• Build strong relationships with KOLs, principal investigators, and study coordinators to drive enrollment and study success.
• Oversee CROs, vendors, and internal clinical staff to ensure high-quality execution and deliverables.
• Ensure compliance with GCP, ISO 14155, FDA, and other applicable regulations.
• Provide clinical insights to R&D, Regulatory Affairs, and Marketing for product development and physician training programs.
• Support the preparation of clinical sections for regulatory submissions and peer-reviewed publications.
• Represent the company at investigator meetings, scientific conferences, and training events.

Qualifications

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related field (advanced degree preferred).
• 8+ years of clinical research or clinical affairs experience in the medical device industry, with at least 3 years in a leadership role.
• Proven track record of working with U.S. and OUS regulatory bodies.
• Strong organizational, communication, and leadership skills.
• Willingness to travel domestically and internationally (approx. 30%).

What We Offer

• Competitive compensation package with performance-based bonus and equity opportunities.
• The opportunity to directly impact the success of groundbreaking neurovascular devices.
• A collaborative, mission-driven team environment.

Seniority level: Seniority level

Employment type: Full-time

Job function: Other

Industries: Medical Equipment Manufacturing

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