Senior Director, Clinical Operations

Senior Director, Clinical Operations – United States This senior leadership role sits at the center of clinical development execution, overseeing the operational strategy and delivery of early‑phase clinical studies. You will drive end‑to‑end clinical operations activities, ensuring studies are executed efficiently, compliantly, and aligned with sponsor objectives. The role combines strategic oversight with hands‑on leadership across CROs, vendors, and cross‑functional study teams. You will play a critical part in shaping study design inputs, operational planning, and executional excellence across Phase I programs. A strong focus is placed on quality, regulatory compliance, and alignment with ICH/GCP and global regulatory standards. You will collaborate directly with sponsors, internal stakeholders, and external partners to ensure timelines, budgets, and deliverables are met. This is a high‑impact role where your leadership directly influences the success of early clinical development programs. Accountabilities Lead clinical operations and study management activities across Phase I clinical development programs. Oversee CRO and vendor selection, including scope development, budgets, timelines, and contractual agreements. Provide strategic and operational oversight of clinical trial execution from start‑up through database lock and reporting. Ensure studies are conducted in compliance with SOPs, ICH/GCP guidelines, and applicable regulatory requirements. Collaborate with QA teams to support audits, review quality systems, and maintain inspection readiness. Drive study planning activities including timelines, metrics, resource allocation, and budget oversight. Review and contribute to key clinical study documents such as protocols, IBs, INDs, and informed consent forms. Manage vendor performance, invoices, and change orders while ensuring alignment with project objectives. Oversee data quality processes including discrepancy management and eCRF review. Contribute to clinical operations quality systems, SOP development, and process improvements. Provide leadership, mentoring, and communication across study teams and stakeholders to ensure project alignment and execution. Requirements Bachelor’s degree in life sciences or related scientific discipline required; advanced degree preferred. 15+ years of experience in clinical research, CRO, pharmaceutical, or biotechnology environments. Strong expertise in Phase I clinical development and early clinical operations. Proven experience managing CROs, vendors, and cross‑functional clinical study teams. Deep knowledge of ICH/GCP guidelines, regulatory requirements (FDA, EMA), and clinical compliance standards. Experience with clinical trial budgets, contracts, vendor agreements, and financial oversight. Strong leadership skills with the ability to manage complex, multi‑disciplinary programs. Excellent communication, stakeholder management, and cross‑functional collaboration skills. Strong analytical thinking, problem‑solving ability, and attention to detail in fast‑paced environments. Proficiency in MS Office and familiarity with project management tools and clinical systems. Preferred: prior experience managing direct reports and developing SOPs or clinical quality systems. Benefits Competitive executive‑level compensation package (aligned with experience and market standards) Comprehensive medical, dental, and vision insurance coverage Retirement savings plan with employer contributions Paid time off, holidays, and flexible work arrangements Career development opportunities within a global clinical research environment Exposure to innovative early‑phase drug development programs Collaborative, science‑driven, and mission‑focused work culture Opportunities to work with leading sponsors and global clinical stakeholders #J-18808-Ljbffr