Associate Director, Nonclinical Study Ops

Lilly; United States; Remote; USD 129,000 - 231,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Health benefits

Job summary

Lilly in Boston, MA is seeking an Associate Director, Study Operations Manager - Nonclinical Toxicology to lead day-to-day operations across toxicology studies, manage CROs, budgets, and study forecasting, ensuring accuracy and regulatory compliance.

You will coordinate with toxicology, DMPK, CMC teams, oversee data management, study reports, and ensure timely delivery of study milestones across a portfolio of Orexin agonist programs.

Qualifications

• BSc or MSc in toxicology, pharmacology or a related discipline.
• Minimum 6 years of biotech/pharma experience in nonclinical toxicology/safety pharmacology with CROs.
• Strong understanding of biological sciences and nonclinical research methodologies.

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams.
• Draft SOWs with CROs for awarded studies.
• Coordinate internal reviews of draft study protocols and reports with DMPK, CMC and bioanalytical teams.
• Coordinate compound shipments with CMC team.
• Monitor nonclinical studies to ensure scientific quality and regulatory compliance.
• Track study deliverables and provide updates to stakeholders.

Skills

Data management

Communication

Organization

Cross-functional collaboration

Education

BSc/MSc in toxicology/pharmacology

Tools

Data analysis software

Job description

Lilly in Boston, MA is seeking an Associate Director, Study Operations Manager - Nonclinical Toxicology to lead day-to-day operations across toxicology studies, manage CROs, budgets, and study forecasting, ensuring accuracy and regulatory compliance.

You will coordinate with toxicology, DMPK, CMC teams, oversee data management, study reports, and ensure timely delivery of study milestones across a portfolio of Orexin agonist programs.