[Hiring] Senior Advisor, Study Operations Manager - Nonclinical Toxicology @Lilly

Role Description

Centessa Pharmaceuticals is seeking an experienced Senior Advisor, Study Operations - Nonclinical Toxicology to manage and oversee day-to-day operations for toxicology and safety pharmacology studies conducted in the selected CROs. This role includes:

• Managing end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives.
• Initiating draft SOWs with multiple CROs for awarded studies in collaboration with toxicology project representatives.
• Coordinating with CRO study director to initiate the internal reviewing process of draft study protocols and study reports.
• Coordinating compound shipments with CMC team.
• Monitoring nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely.
• Tracking study deliverables and providing timely updates on study progress to relevant team members, regulatory leads, and senior management.
• Maintaining an integrated calendar by working with Project Management team to forecast study deliverables.
• Attending project meetings to stay informed and expedite study-related activities as needed.

Qualifications

• BSc or MSc in toxicology, pharmacology or a related discipline.
• Minimum 6 years of biotechnology or pharmaceutical industry experience in conducting nonclinical toxicology/safety pharmacology, ADME/DMPK studies 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 packages, databases, and data management systems.
• Excellent communication (oral and written), listening, negotiation and interpersonal relationship skills.

Requirements

• Experience supporting CNS, neuroscience, sleep-wake, rare disease, or related therapeutic areas.
• Experience contributing to IND or CTA submissions.
• Familiarity with FDA, EMA, and ICH regulatory requirements.
• Experience working in fast-paced, matrixed biotechnology environments.
• Excellent organizational skills, IT savvy.
• Intrinsically curious and deeply passionate about the work we do.
• Embrace ambiguity and push for new practices and technologies.
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions.

Benefits

• Anticipated wage for this position is $144,000 - $231,000.
• Eligibility for a company bonus (depending on company and individual performance).
• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance and death benefits; and well-being benefits.