Associate Director, Clinical Operations

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company is advancing a portfolio of high conviction programs with strong biological validation.  Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data driven capital allocation.   Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Description: The Associate Director, Clinical Operations, will provide leadership and operational oversight for assigned clinical trials and programs throughout the clinical development lifecycle. This role will support the strategic planning, execution, quality, and compliance, ensuring study objectives are met on time, within budget, and according to applicable regulatory standards (e.g., GCP, ICH). The successful candidate will collaborate cross-functionally and support our mission to bring transformational medicines to patients.

Lead and oversee end-to-end clinical trial operations from study start-up through close-out for Centessa’s Orexin development programs.   Develop and execute operational plans, timelines, and performance metrics to support successful delivery of assigned studies.   Partner closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.   Contribute to the development and review of key study documents, including protocols, informed consent forms, monitoring plans, EDC specifications, and statistical analysis plans.   Develop, manage, and track clinical trial budgets, ensuring studies are delivered within approved financial parameters.   Provide regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.   Proactively identify operational risks and implement mitigation strategies to maintain timelines, quality, and compliance.   Support and facilitate execution of contracts, clinical trial agreements, and study budgets.   Contribute to regulatory strategy and support preparation of submissions to regulatory authorities, including FDA, IRBs, and ECs.   Manage and oversee CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.   Ensure all clinical operations activities comply with company SOPs, GCP, and ICH guidelines, and support inspection readiness as needed.

Bachelor’s degree in sciences field required; advanced degree preferred.   8 + years of experience in pharmaceutical , biotechnology, or CRO environments.   Proven experience managing clinical trials across multiple phases (Phase 1–3), including domestic and international studies.   Experience supporting global clinical trials preferred.   CNS and/or sleep disorder experience preferred.   Prior experience supporting FDA regulatory submissions is a plus.   Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP.   Solid understanding of