Associate Director, Nonclinical Study Operations

Lilly; Boston (MA); On-site; USD 129,000 - 231,000; Full time

Job summary

Lilly, in partnership with Centessa Pharmaceuticals, seeks an experienced Associate Director, Study Operations - Nonclinical Toxicology to oversee day-to-day CRO toxicology studies, budgeting, data management, and regulatory alignment across Orexin agonist programs from its Boston area operations.

The role requires a MSc/BSc in toxicology or related field, 6+ years in biotech/pharma with CROs, strong scientific and operational rigor, and excellent communication to lead cross-functional teams in

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 with CROs and external development partners
• Strong understanding of biological sciences and nonclinical research methodologies
• Highly organized, with proven ability to manage multiple simultaneous toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables
• Proficient in scientific data analysis software, databases, and data management systems
• Excellent communication (oral and written), listening, negotiation and interpersonal skills

Responsibilities

• 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 to ensure accuracy of study design and to execute SOWs in a timely fashion.
• Coordinate with CRO study director to initiate the internal reviewing process of draft study protocols and study reports for tox/safety pharm studies with DMPK, CMC and bioanalytical team members
• Coordinate compound shipments with 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 relevant team members, regulatory leads, and senior management in order to advance drug candidates through research and development
• Maintain an integrated calendar by working with Project Management team to forecast study deliverables across entire portfolio for efficient planning of resources
• Attend project meetings to stay informed and expedite study-related activities as needed, and provide updates to project teams upon request

Skills

Data analysis software

Excellent communication

Highly organized

Interpersonal skills

Negotiation

Adaptability

Education

BSc or MSc in toxicology, pharmacology or a related discipline

Tools

Scientific data analysis software

Databases

Data management systems

Job description

Lilly, in partnership with Centessa Pharmaceuticals, seeks an experienced Associate Director, Study Operations - Nonclinical Toxicology to oversee day-to-day CRO toxicology studies, budgeting, data management, and regulatory alignment across Orexin agonist programs from its Boston area operations.

The role requires a MSc/BSc in toxicology or related field, 6+ years in biotech/pharma with CROs, strong scientific and operational rigor, and excellent communication to lead cross-functional teams in