Senior Advisor, Study Operations Manager - Nonclinical Toxicology (remote)

Organization and Position Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

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 to include study forecasting, budgeting, planning, data management, quality assurance, compliance, communications and collaboration with different functional teams across the portfolio of Orexin agonist programs. This role aligns closely with Centessa's planned expansion of translational science and nonclinical development capabilities, and requires a high degree of accuracy, attention to detail, and the ability to identify and resolve issues that arise during the conduct of studies.

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

Basic Requirements

• 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

Additional Preferences

• 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