Associate Director, Study Operations Manager - Nonclinical Toxicology

100 Eli Lilly and Company; United States; Remote; USD 129,000 - 231,000; Full time

Job summary

Lilly is seeking an Associate Director, Study Operations - Nonclinical Toxicology to manage day-to-day toxicology studies across CROs, including forecasting, budgeting, planning, data management, and QA. The role requires leading cross-functional collaboration and ensuring timely execution across the portfolio of orexin-related programs.

Success factors include a strong background in toxicology or pharmacology, 6+ years in biotech/pharma, and exceptional communication skills to coordinate with

Qualifications

• BSc or MSc in toxicology, pharmacology or a related discipline.
• Minimum 6 years of biotechnology or pharmaceutical industry experience in nonclinical toxicology/safety pharmacology.
• Strong understanding of biological sciences and nonclinical research methodologies.
• Excellent communication (oral and written) and ability to manage multiple studies.

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams for tox/safety pharmacology studies.
• Draft SOWs with CROs to ensure accurate study design and timely execution.
• Coordinate with study directors to review study protocols and reports with DMPK, CMC, and bioanalytical teams.
• Coordinate compound shipments with CMC team.
• Monitor studies at external CROs to ensure quality and regulatory compliance.
• Track deliverables and provide updates to teams and senior management.
• Forecast study deliverables with Project Management for resource planning.
• Attend project meetings and provide updates as needed.

Skills

Nonclinical toxicology

Data analysis

Project coordination

Communication skills

ADME/DMPK studies

Regulatory knowledge

Education

BSc or MSc in toxicology, pharmacology or related discipline

Tools

Data management systems

Statistical software

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.

Organization and Position Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026. Centessa Pharmaceuticals is seeking an experienced Associate Director, Study Operations - Nonclinical Toxicology to manage and oversee day-to-day operations for toxicology and safety pharmacology studies conducted in the selected CROs to include study forecasting, budgeting, planning, data management, quality assurance, compliance, communications and collaboration with different functional teams across the portfolio of Orexin agonist programs. This role aligns closely with Centessa's planned expansion of translational science and nonclinical development capabilities, and requires a high degree of accuracy, attention to detail, and the ability to identify and resolve issues that arise during the conduct of studies.

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives
• Initiate draft SOWs with multiple CROs for awarded studies in collaboration with toxicology project representatives to ensure accuracy of study design and to execute SOWs in a timely fashion.
• Coordinate with CRO study director to initiate the internal reviewing process of draft study protocols and study reports for tox/safety pharm studies with DMPK, CMC and bioanalytical team members
• Coordinate compound shipments with CMC team.
• Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, to ensure scientific quality and compliance with global regulatory requirements.
• Track study deliverables and provide timely updates on study progress to relevant team members, regulatory leads, and senior management in order to advance drug candidates through research and development
• Maintain an integrated calendar by working with Project Management team to forecast study deliverables across entire portfolio for efficient planning of resources
• Attend project meetings to stay informed and expedite study-related activities as needed, and provide updates to project teams upon request

Basic Requirements

• BSc or MSc in toxicology, pharmacology or a related discipline
• Minimum 6 years of biotechnology or pharmaceutical industry experience in conducting nonclinical toxicology/safety pharmacology, ADME/DMPK studies with CROs and external development partners
• Strong understanding of biological sciences and nonclinical research methodologies
• Highly organized, with proven ability to manage multiple simultaneous toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables
• Proficient in scientific data analysis software packages, databases, and data management systems, with the ability to quickly learn and adapt to new software tools
• Must have excellent communication (oral and written), listening, negotiation and interpersonal relationship skills

Additional Preferences

• Experience supporting CNS, neuroscience, sleep-wake, rare disease, or related therapeutic areas
• Experience contributing to IND or CTA submissions
• Familiarity with FDA, EMA, and ICH regulatory requirements
• Experience working in fast-paced, matrixed biotechnology environments.
• Excellent organizational skills, IT savvy
• Intrinsically curious and deeply passionate about the work we do
• Embrace ambiguity and push for new practices and technologies
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn’t clear

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 $129,000 - $231,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and 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.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly