Director Clinical Operations

ABOUT:

Meet is partnered with a top medical device company on their mission to treat rare diseases and cancers through bioelectronic technology as they search for a Director of Clinical Operations. They are a team of passionate individuals who are committed to making a meaningful impact on healthcare.

Key Responsibilities:

• Leads clinical operations and cross-functional teams in planning, executing, and reporting clinical trials, including managing study budgets, external resources (consultants, contractors, CROs), and vendor documents.
• Develops project plans with timelines, budgets, and milestones, and prepares or supports clinical documents, SOPs, and regulatory submissions.
• Coordinates vendor meetings, ensures compliance with trial protocols, ICH/GCP guidelines, and SOPs, and identifies training needs.
• Supervises direct reports and matrixed teams, maintaining high standards of compliance and professionalism.

Qualifications:

• Bachelor’s or RN degree with 10+ years in Clinical Operations, including 5+ years as a study manager or lead in a medical device company, covering all aspects of clinical trial design, implementation, site management, and data management.
• Proven experience managing at least one successful CRO clinical trial, with strong knowledge of GCP, ICH guidelines, and FDA regulations.
• Demonstrated project management skills, ability to lead teams, adapt to changing priorities, and work effectively in a fast-paced environment with a keen attention to detail.
• Strong problem-solving abilities, organizational skills, and the capability to travel approximately 35%.

Full job description and company details are available upon application. This position is being dealt with by Payton Baker at Meet, please email payton@peoplewithchemistry.com if you would like to discuss more about this opportunity in confidence.