Associate Director, Clinical Operations

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 189,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) plan

Pension

Vacation benefits

Health, dental, vision coverage

Job summary

Lilly, headquartered in Indianapolis, invites a seasoned Associate Director, Clinical Operations, to lead end-to-end trial activities across Orexin programs. You will drive operational plans, budgets, and cross-functional collaboration to meet study objectives in a compliant, timely manner.

The role requires 8+ years in pharma/biotech/CRO settings, strong leadership, and experience with global Phase 1–3 studies and regulatory submissions.

Qualifications

• Bachelor’s degree in sciences; advanced degree preferred.
• 8+ years in pharmaceutical/biotech/CRO environments.
• Experience managing multi-phase trials (Phase 1–3) globally.

Responsibilities

• Lead end-to-end clinical trial operations from start-up to close-out.
• Develop operational plans, timelines, and performance metrics.
• Collaborate with Regulatory, Data Management, Biostatistics, Safety, and other teams.
• Oversee budgets and ensure studies stay within financial parameters.
• Provide updates on study status, risks, and milestones to leadership.
• Ensure compliance with GCP, ICH, and SOPs; support inspections.
• Manage CROs, vendors, and external partners.

Skills

Trial management leadership

Cross-functional collaboration

GCP/ICH knowledge

Regulatory submissions support

Vendor management

Communication skills

Organizational skills

Proactive problem-solving

PMP certification

Education

Bachelor's degree in sciences

Advanced degree preferred

Tools

Clinical Trial Management Systems

Job description

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.

Overview

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.

Position 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.

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.

Basic 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.
• 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.
• 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.
• 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.

Additional Preferences

• 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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $117,000 - $189,200.

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for 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)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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