About This Role
Directing clinical operations with a focus on strategic oversight and accountability for clinical development programs is the core of this role. It involves leading all operational functions for clinical projects and representing clinical development. The Director is responsible for the operational strategy and execution of assigned clinical program(s), ensuring high-quality, on-schedule, and cost-effective delivery.
Responsibilities
- Lead and oversee end-to-end clinical operations across all programs, ensuring inspection-ready, high-quality execution from study start-up through closeout
- Develop and maintain integrated clinical trial timelines and operational roadmaps aligned with corporate strategy, program objectives, and key development milestones
- Partner with executive leadership and cross-functional teams to translate clinical development strategy into actionable operational plans
- Provide strategic oversight of CROs, vendors, and clinical trial sites, including identification, qualification, selection, onboarding, and performance management
- Serve as the primary operational lead for external partners, ensuring adherence to timelines, deliverables, budget, quality expectations, and contractual obligations, including SOWs, proposals, and change orders
- Lead study start-up and trial execution activities, including feasibility, site selection, enrollment planning, risk management, and vendor oversight
- Oversee clinical trial budgets, resource planning, forecasting, and financial reporting, ensuring cost control and alignment with corporate goals
- Establish and drive risk-based operational strategies to proactively identify, escalate, and mitigate study risks impacting quality, timelines, and patient safety
- Monitor study progress through KPIs, KRIs, dashboards, and other trial metrics to enable data-driven decision-making and continuous improvement
- Collaborate closely with biostatistics to plan, review, and ensure the quality and timely delivery of statistical and data outputs (including TLFs and SAPs) to ensure accurate integration into the TMF, clinical study reports, and regulatory submission documents
- Build, optimize, and maintain Clinical Operations infrastructure, including SOPs, processes, workflows, governance, and scalable operating models
- Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements, and contribute operational input to regulatory submissions and agency interactions
- Partner with Quality Assurance and Regulatory Affairs to support audits, inspections, CAPAs, and ongoing inspection readiness
- Evaluate and implement CTMS, eTMF, EDC, and other clinical systems and technologies to support efficient, scalable, and compliant trial execution
- Act as a key strategic and operational partner to the Chief Medical Officer, driving execution of the clinical development plan across programs