Overview
Position Summary:
We are currently seeking an experienced and strategic clinical operations leader to serve as Director of Clinical Operations.
- The director will oversee operational and regulatory activities across the full clinical development lifecycle, ensuring the delivery of high-quality, compliant studies within agreed timelines and budgets, from feasibility through to post-market clinical follow-up.
- The ideal candidates should have experience in clinical operations with substantial regulatory involvement, including direct engagement with competent authorities and thorough understanding of applicable international and regional standards governing clinical investigations and market approvals for medical devices.
- A strong background in the medical device sector is essential, particularly in pre-market and post-market studies, along with demonstrated expertise in rheumatology or other relevant therapeutic areas.
Key Responsibilities:
- Lead multi-country clinical studies in rheumatology, ensuring compliance with GCP, ISO standards, FDA/MHRA regulations, and GDPR.
- Oversee regulatory submissions (IND/IDE, CTA) and act as the primary liaison with FDA, MHRA, IRBs, and other authorities.
- Ensure the quality and compliance of all clinical documentation and reports.
- Collaborate with cross-functional teams to align deliverables and timelines.
- Manage CROs, vendors, and sites while maintaining budget and operational oversight.
- Implement risk management strategies and contribute U.S.-specific insights to global development plans.
