Director Clinical Research

Director Clinical Research

Location: East Coast Preferable (Remote with Travel Requirements)

About the Company: A pioneering neuromodulation start-up focused on developing cutting-edge technology to transform patient care.

Position Overview: Our client is seeking their first US hire, a Director Clinical Research, to lead their clinical strategy and operations. The role involves supporting the IDE process with the goal of achieving FDA approval while collaborating with the European team.

Key Responsibilities:

• Lead and manage US clinical operations, including clinical trial design and oversight.
• Develop and execute clinical strategies for the IDE process.
• Ensure compliance with FDA regulations.
• Collaborate with cross-functional teams to align clinical objectives.
• Build relationships with key opinion leaders, clinical investigators, and study sites.
• Oversee clinical documentation preparation and submission to regulatory authorities.
• Manage clinical trial budgets, timelines, and resources.
• Provide leadership and mentorship to clinical team members.
• Travel to Europe as needed.

Qualifications:

• Minimum 10 years of experience in clinical operations within the medical device
• Class III Medical Device experience is required
• Successful track record with clinical trials and FDA approvals.
• Deep understanding of IDE and FDA regulatory processes.
• Excellent leadership and communication skills.
• Ability to work independently in a start-up environment.
• Willingness to travel domestically and internationally.

Interested in this position - get in touch with Ryan Tosh

Email: [email protected]