Associate Director, Study Operations Manager – Nonclinical Toxicology

Eli Lilly and Company

. Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives .

Posted 10/27/2026full-timeRemote • Massachusetts • United StatesSenior💰 $129,000 - $231,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing nonclinical toxicology and safety pharmacology studies, ensuring compliance with FDA, EMA, and ICH regulatory requirements. Proficient in coordinating with CROs and internal teams while maintaining effective communication and organizational skills.

Highest-signal resume keywords

Nonclinical Toxicology ManagementSafety Pharmacology StudiesADME/DMPK StudiesRegulatory ComplianceScientific Data Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

ToxicologyPharmacologyBiological SciencesData Management SystemsScientific Data Analysis SoftwareStudy ProtocolsStudy ReportsSOW DraftingProject CoordinationDeliverable Tracking

Soft Skills

Communication SkillsInterpersonal SkillsNegotiation SkillsOrganizational SkillsListening Skills

Certifications & Qualifications

BSc in ToxicologyMSc in Pharmacology

Industry Keywords

BiotechnologyPharmaceutical IndustryCRO CoordinationIND SubmissionsCTA SubmissionsCNSNeuroscienceRare DiseaseMatrixed EnvironmentsGlobal Regulatory Requirements

About the role

Key responsibilities & impact

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
Coordinate internal review of draft study protocols and study reports for toxicology and safety pharmacology studies with DMPK, CMC and bioanalytical team members
Coordinate compound shipments with the CMC team
Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, ensuring scientific quality and compliance with global regulatory requirements
Track study deliverables and provide timely progress updates to team members, regulatory leads, and senior management
Maintain an integrated calendar with the Project Management team to forecast portfolio study deliverables and plan resources
Attend project meetings, expedite study-related activities, and provide updates to project teams

Requirements

What you’ll need

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
Proven ability to manage multiple simultaneous toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables
Proficiency in scientific data analysis software packages, databases, and data management systems
Excellent oral and written communication, listening, negotiation and interpersonal relationship skills
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 and IT savvy

Benefits

Comp & perks

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, 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