Senior Study Operations Director - 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

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