Head of Study Operations & CRO Partnerships

BioSpace; Indianapolis (IN); On-site; USD 129,000 - 231,000; Full time

Benefits offered by this job

401(k) participation

Health benefits (medical/dental/vision

Well-being programs

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a senior professional to manage end-to-end data flow between CROs and internal teams for nonclinical toxicology and safety pharmacology programs. The role involves starting draft SOWs with CROs, coordinating study protocols, and ensuring timely, regulatory-compliant study deliverables across DMPK, CMC, and bioanalytical teams.

The candidate will monitor external studies, track progress, and collaborate with regulatory leads and senior

Qualifications

• Excellent communication (oral and written)
• Strong understanding of biological sciences and nonclinical research methodologies
• Highly organized with ability to manage multiple studies and data deliverables
• Proficient in scientific data analysis software and data management systems

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams
• Draft SOWs with CROs for awarded studies in collaboration with toxicology representatives
• Coordinate study protocols and reports review with tox/safety pharmacology teams
• Coordinate compound shipments with CMC team
• Monitor nonclinical toxicology and safety pharmacology studies at CROs for quality and regulatory compliance
• Track study deliverables and provide updates to stakeholders to advance drug candidates
• Forecast study deliverables with Project Management for efficient planning
• Attend project meetings and provide updates to teams on request

Skills

Communication

Biological sciences

Data analysis

Organizational skills

Negotiation & interpersonal skills

Education

BSc or MSc in toxicology

Related discipline (toxicology/pharmacology)

Job description

Lilly, headquartered in Indianapolis, Indiana, is seeking a senior professional to manage end-to-end data flow between CROs and internal teams for nonclinical toxicology and safety pharmacology programs. The role involves starting draft SOWs with CROs, coordinating study protocols, and ensuring timely, regulatory-compliant study deliverables across DMPK, CMC, and bioanalytical teams.

The candidate will monitor external studies, track progress, and collaborate with regulatory leads and senior