Senior Advisor, 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 11/5/2026full-timeRemote • United StatesSenior💰 $144,000 - $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 scientific data analysis and adept at coordinating with CROs and internal teams to deliver study objectives efficiently.

Highest-signal resume keywords

Nonclinical Toxicology ManagementSafety Pharmacology ExpertiseADME/DMPK Studies CoordinationRegulatory Submissions ExperienceScientific Data Analysis Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Nonclinical ToxicologySafety PharmacologyADME StudiesDMPK StudiesScientific Data AnalysisData Management SystemsBiological Sciences UnderstandingRegulatory ComplianceStudy Protocol DevelopmentProject Management

Soft Skills

Excellent CommunicationInterpersonal Relationship SkillsNegotiation SkillsOrganizational SkillsAdaptive Problem-Solving

Tools & Technologies

Scientific Data Analysis SoftwareDatabasesData Management Systems

Industry Keywords

BiotechnologyPharmaceutical IndustryCRO CoordinationIND SubmissionsCTA SubmissionsCNS Therapeutic AreasNeuroscienceRare Disease

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
Execute SOWs in a timely fashion
Coordinate with CRO study directors to initiate internal review of draft study protocols and study reports for toxicology and safety pharmacology studies
Coordinate compound shipments with the 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 team members, regulatory leads, and senior management
Maintain an integrated calendar with the Project Management team to forecast study deliverables across the portfolio and plan resources efficiently
Attend project meetings and expedite study-related activities as needed
Provide updates to project teams upon request

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
Proficient in scientific data analysis software packages, databases, and data management systems, with the ability to quickly learn and adapt to new software tools
Excellent communication (oral and written), 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
IT savvy
Intrinsically curious and deeply passionate about the work we do
Ability to embrace ambiguity and push for new practices and technologies
Adaptive problem-solving ability

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Certain time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities