Senior Study Operations Director, Nonclinical Toxicology

Eli Lilly and Company; Indianapolis (IN); On-site; USD 129,000 - 231,000; Full time

Job summary

Centessa Pharmaceuticals is seeking an experienced Associate Director, Study Operations - Nonclinical Toxicology to lead day-to-day toxicology and safety pharmacology studies across external CROs. You’ll manage data flow, budgeting, forecasting, and compliance across programs in a fast-paced environment.

Based in the US, you’ll collaborate with DMPK, CMC, bioanalytical teams and regulatory leads to ensure study quality, timely delivery, and alignment with global regulatory requirements.

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 and external development partners.
• Strong understanding of biological sciences and nonclinical research methodologies.
• Highly organized with ability to manage multiple simultaneous studies, timelines, and data deliverables.
• Excellent communication, listening, negotiation and interpersonal skills.

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy and alignment with study objectives.
• Initiate draft SOWs with multiple CROs for awarded studies with toxicology project representatives.
• Coordinate with CRO study director to review draft protocols and reports with DMPK, CMC and bioanalytical teams.
• Coordinate compound shipments with CMC team.
• Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, for quality and regulatory compliance.
• Track study deliverables and provide updates to team members, regulatory leads, and senior management.
• Maintain an integrated calendar with Project Management to forecast study deliverables across portfolios.
• Attend project meetings and provide updates to project teams as needed.

Skills

Data analysis

Study coordination

Regulatory knowledge

Communication

Education

BSc in toxicology

MSc in toxicology

Tools

Data management systems

Job description

Centessa Pharmaceuticals is seeking an experienced Associate Director, Study Operations - Nonclinical Toxicology to lead day-to-day toxicology and safety pharmacology studies across external CROs. You’ll manage data flow, budgeting, forecasting, and compliance across programs in a fast-paced environment.

Based in the US, you’ll collaborate with DMPK, CMC, bioanalytical teams and regulatory leads to ensure study quality, timely delivery, and alignment with global regulatory requirements.