Senior Director, Toxicology

COMPANY

Centessa Pharmaceuticals plc (Nasdaq: CNTA) 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.

SUMMARY

The Senior Director of Toxicology will be responsible for building the overall toxicology strategy as well as targeted toxicology packages to support regulatory submissions for Centessa’s Orexin Agonist small molecule drug discovery programs from IND to NDA. The successful candidate will have substantial experience in CNS drug development with the knowledge and ability to contribute effectively to cross-functional drug development teams. They will have demonstrated experience in managing CRO’s to successfully conduct regulatory-compliant toxicology studies, and they will lead outsourcing efforts for the design, monitoring, execution and reporting of all nonclinical toxicology studies. As the nonclinical Safety Assessment lead for multiple programs, they will have responsibility for evaluating and authoring responses to inquiries from health authorities addressing global nonclinical development issues in support of IND/CTA and NDA filings.

RESPONSIBILITIES

• Conceptualize overall toxicology strategies for accelerated global orexin agonist programs
• Manage and monitor nonclinical toxicology studies at external CROs and ensure compliance with global regulatory requirements
• Lead the development and execution of GLP and non-GLP toxicology study designs; critically review and edit nonclinical toxicology study reports, and coordinate report finalization with CROs
• Responsible for toxicology data analysis and interpretation, authoring nonclinical sections for regulatory documents including IND/CTA/IB/DSUR/NDA to ensure clarity and regulatory compliance
• Proactively identify gaps and emerging risks in development programs, and engage the appropriate external experts to inform and guide risk management strategies
• Maintain a current understanding of relevant literature and methodology as well as scientific literature related to orexin agonists and CNS toxicological assessment
• Sustain and continue to expand a robust professional network of external experts to inform the design and execution of toxicology strategy including subject matter experts in orexin agonist biology and regulatory requirements
• Demonstrate strong cross-functional teamwork across all disciplines involved in drug development including pharmacology, ADME, clinical, regulatory, and CMC; ensure integration of toxicology activities and results into overall project plans
• Flexible working through virtual and in-person interactions to coordinate with global team members and vendors.

QUALIFICATIONS & EXPERIENCE

• Ph.D. in Toxicology, Pharmacology, Biology or related discipline with 10+ years pharmaceutical industry experience in neuroscience drug development toxicology. Board certification (e.g., DABT) is highly desirable
• Strong knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
• Deep understanding of QA, regulatory, and clinical functions to guide key nonclinical safety assessment activities to support progression of drug candidates at all stages of development
• Demonstrated experience in serving as the Safety Assessment lead in cross-functional drug development teams
• Experience in authoring non-clinical elements of major regulatory submissions and other regulatory documents; preparation of science-based responses to regulatory enquiries
• Experience in leading successful outsourcing and monitoring of toxicology studies, effectively interacting with CRO study directors and others as needed in data analyses and interpretation for timely delivery of high-quality toxicology study reports
• Previous interaction with FDA Psychiatry and Neurology divisions is highly desirable
• Sense of urgency, detail oriented, ability to function well in a hands-on environment
• Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents

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.