Associate Director, Clinical Trial Lead

Associate Director, Clinical Trial Lead Cambridge, MA (Hybrid) | 📄 6-Month Rolling Contract | Potential for Permanent Hire We're partnering with an innovative biotechnology company to identify an experienced Associate Director, Clinical Trial Lead to provide strategic and operational leadership for a global Phase I clinical trial. This is an outstanding opportunity for a senior Clinical Operations professional to lead cross-functional study teams, oversee CRO and vendor partnerships, and drive the successful execution of global clinical studies from start-up through close-out. Reporting into Clinical Operations leadership, you'll play a pivotal role in ensuring studies are delivered on time, within budget, and in compliance with global regulatory requirements while contributing to broader clinical development strate gy. What You'll Be Doing Lead the operational execution of a global, multi-center Phase I clinical trial. Provide strategic leadership across cross-functional study teams throughout the study lifecycle. Partner with Clinical Operations leadership to develop study strategy, timelines, budgets, vendor selection, and risk mitigation plans. Oversee CROs and external vendors, ensuring accountability, quality, and timely delivery. Support protocol development, amendments, clinical study reports, and other essential study documenta tion.Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Provide oversight of Trial Master File (TMF) quality and clinical trial registry submissions. Collaborate with Finance and Legal on study budgets, contracts, invoices, and scope changes. Drive operational excellence through continuous process improvement initiatives. What You'll Bring Bachelor's degree in Life Sciences or a related scientific discipline (advanced degree preferred). 8+ years of Clinical Trial Management experience within biotechnology or pharmaceutical organizations. Demonstrated experience operating at a Clinical Trial Lead or Associate Director level. Proven leadership of global clinical studies and cross-functional project teams. Strong experience managing CROs, vendors, and external partners. Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations. Excellent communication, leadership, and project management skills. Why Join? Lead a high-profile global Phase I clinical program. Opportunity to work within an innovative and collaborative biotech environment. Hybrid working based in Cambridge, MA Initial 6-month contract with strong potential for extension or conversion into a permanent hire. Competitive compensation.