Associate Director, Clinical Operations

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $117k - $189.2k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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 for assigned studies • Partner with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions • Contribute to key study documents, including protocols, informed consent forms, monitoring plans, EDC specifications, and statistical analysis plans • Develop, manage, and track clinical trial budgets • Provide updates on study status, risks, and milestones to senior leadership and stakeholders • Identify operational risks and implement mitigation strategies • Support execution of contracts, clinical trial agreements, and study budgets • Contribute to regulatory strategy and support submissions to FDA, IRBs, and ECs • Manage CROs, vendors, and other external partners • Ensure compliance with company SOPs, GCP, and ICH guidelines • Support inspection readiness as needed

🎯 Requirements

• Bachelor’s degree in a 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 clinical development project management, including timelines, resources, budgets, and risk • Experience using clinical trial management systems • Demonstrated ability to oversee vendors, CROs, and external partners • PMP certification or formal project management training is a plus • 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 • Intrinsically curious and deeply passionate about the work • Adaptive problem solver able to turn issues into opportunities and translate ideas into solutions • Technical depth and a growth mindset

🏖️ Benefits

• Company bonus depending partly on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision, and prescription drug benefits • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities • Employee resource groups and support networks • Disability accommodation support during the application process