Director Clinical Operations

Remote - East Coast Candidates Only

We are seeking an experienced Director of Clinical Operations to join our San Diego team and work remotely. Reporting to the SVP of Clinical Operations, you will play a crucial role in managing clinical trials and ensuring their successful execution.

Duties/Responsibilities:

• Resource Management: Assess and deploy resources to meet corporate priorities.
• Clinical Trial Implementation: Develop and execute operational plans, ensuring trials are on time, within budget, and compliant with regulations.
• Vendor and CRO Management: Prepare RFPs, evaluate proposals, and manage vendor agreements.
• Site Selection: Evaluate and select clinical sites to meet enrollment and budget goals.
• Documentation and Training: Oversee clinical documentation and provide training to ensure compliance with protocols and regulations.
• Financial Oversight: Review invoices, prepare cost projections, and manage budgets.
• Stakeholder Collaboration: Maintain productive relationships with CROs, vendors, clinical sites, and internal teams.

Requirements:

• Education: Bachelor’s degree in a life science field; advanced degree preferred.
• Experience: Minimum 15 years in the industry, with expertise in clinical operations and CRO/vendor management.
• Skills: Strong knowledge of ICH/GCP guidelines, FDA and EMA regulations. Experience in international studies, autoimmune diseases, oncology, and cell therapy preferred.
• Communication: Excellent oral and written skills.
• Travel: Up to 25%, including international travel.