Associate Director, Clinical Operations

Lilly • Indianapolis, IN

5d • $117,000 - $189,200 • Onsite

About The Position

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.

Requirements

• 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.
• Strong working knowledge of clinical trial operations, global regulatory requirements, ICH guidelines, and GCP.
• Solid understanding of clinical development project management, including timelines, resources, budgets, and risk.
• Creative and adaptable approach to addressing challenges related to timelines, quality, or budget.
• Experience using clinical trial management systems.
• Demonstrated ability to oversee vendors, CROs, and external partners.
• Demonstrated leadership and ability to influence cross‑functional teams without direct authority.
• Strong communication, collaboration, and interpersonal skills.
• Highly organized with the ability to manage multiple priorities in a fast‑paced environment.
• Proactive problem‑solver with the ability to anticipate needs, take initiative, and implement practical solutions.

Nice To Haves

• Experience supporting global clinical trials preferred.
• CNS and/or sleep disorder experience preferred.
• Prior experience supporting FDA regulatory submissions is a plus.
• PMP certification or formal project management training is a plus.
• Intrinsically curious and deeply passionate about the work we do.
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear.
• Leverage technical depth and a growth mindset to make impact; imagine what’s possible and pursue it with intention and energy.

Responsibilities

• 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level