Manager/ Sr. Manager, Study Operations, Nonclinical Toxicology

Manager/ Sr. Manager, Study Operations, Nonclinical Toxicology

Company Name: Centessa Pharmaceuticals

Centessa Pharmaceuticals plc (Nasdaq: CNTA) is a new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data-driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological validation.

Our asset-centric model offers a unique R&D logic that has been applied by single asset companies to improve productivity. This operating model has minimal centralized infrastructure, reduced hierarchy, and exclusive focus on data-driven capital allocation. Our teams are uniquely incentivized to expeditiously interrogate key scientific hypotheses. We believe the asset-centric model can lead to improved success rates for programs with greater speed and modest costs.

Description Of Role

The Study Operational manager will 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 requires a high degree of accuracy, attention to detail, and the ability to identify and resolve issues that arise during the conduct of studies.

Key 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.
• 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.

Qualifications

• BSc or MSc in toxicology, pharmacology or a related discipline.
• Minimum of 7 years’ experience in nonclinical toxicology/safety pharmacology either in pharma company or CRO.
• Strong understanding of biological sciences and nonclinical research methodologies.
• Highly organized, with proven ability to manage multiple simultaneous toxicology/safety pharmacology 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.
• Excellent organizational skills, IT savvy.
• Can-do attitude in a fast-paced working environment.

Work Location

The Manager/ Sr. Manager, Study Operations, Nonclinical Toxicology role is a remote role based in the US, with occasional travel.

POSITION

Full-Time, Exempt

EEOC Statement

Centessa Pharmaceuticals believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Centessa Pharmaceuticals will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note:

We will not assign referral rights for any unsolicited resumes from recruitment agencies.