[Remote] Associate Director, Study Operations Manager - Nonclinical Toxicology

Note: The job is a remote job and is open to candidates in USA. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is hiring an Associate Director, Study Operations Manager – Nonclinical Toxicology to oversee day-to-day operations of toxicology and safety pharmacology studies across its orexin agonist programs. The role manages CRO study execution, data flow, planning, budgeting, compliance, and collaboration with internal project teams.

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

• 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, with the ability to quickly learn and adapt to new software tools
• Must have excellent communication (oral and written), listening, negotiation and interpersonal relationship skills
• 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, even when the path isn't clear

Benefits

• Company bonus (depending, in part, on company and individual performance)
• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Employee resource groups (ERGs) offer strong support networks for their members and are open to all employees

Company Overview

Company H1B Sponsorship