Define and execute nonclinical safety strategies for assigned small molecule CNS programs across discovery, IND-enabling, and clinical development stages.
Develop safety strategies for new CNS targets, lead optimization programs, and platform technologies.
Proactively identify gaps and emerging risks within assigned programs and implement risk mitigation plans, engaging external experts as appropriate.
Maintain a current understanding of scientific literature and regulatory guidance relevant to CNS toxicological assessment, and sustain a professional network of external subject matter experts to inform program strategy.
Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies, with emphasis on endpoints and models relevant to CNS-active small molecules.
Lead outsourcing efforts for the design, monitoring, execution, and reporting of nonclinical toxicology studies, ensuring scientific quality, regulatory compliance, and timely delivery.
Manage and monitor outsourced toxicology and safety pharmacology studies at external CROs, interacting effectively with CRO study directors throughout study conduct.
Critically review and edit nonclinical study reports and coordinate report finalization with CROs.
Integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform candidate selection and program decisions.
Author and critically review the toxicology sections of global regulatory documents, including pre-IND packages, INDs, CTAs, IBs, DSURs, and NDA submissions.
Prepare science-based written responses to nonclinical inquiries from health authorities (FDA, EMA, and other global regulators).
Collaborate closely with peers in biology, DMPK, pathology, pharmacology, clinical, regulatory, and CMC to ensure toxicology activities and findings are integrated into overall program plans.
Provide day-to-day scientific direction and mentorship to entry-level toxicology staff supporting assigned programs.
Work independently to plan, prioritize, and deliver on program toxicology objectives.
Requirements
PhD in Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related discipline; board certification (e.g., DABT, ERT).
13+ years of pharmaceutical or biotechnology R&D experience with a strong track record in nonclinical and regulatory toxicology.
Substantial experience supporting CNS / neuroscience drug development (required).
Deep expertise supporting small molecule programs across discovery, IND-enabling, and early clinical development, with demonstrated experience advancing CNS-active candidates.
Demonstrated experience serving as the toxicology lead on cross-functional drug development programs.
Extensive experience authoring and reviewing nonclinical sections of global regulatory submissions (IND/CTA/IB/DSUR/NDA) and preparing written responses to health authority inquiries.
Strong working knowledge of FDA, EMA, and ICH guidance documents and GLP regulations, with a solid understanding of how QA, regulatory, and clinical functions interface with nonclinical safety assessment.
Demonstrated success leading outsourcing and oversight of toxicology and safety pharmacology studies and managing CRO study directors and partnerships.
Strong ability to i
Benefits
Health insurance
Additional Information
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.
Description of Role
Centessa is seeking a Senior Director, Toxicology to provide scientific and technical leadership for nonclinical safety in our CNS programs. Reporting to the SVP, Nonclinical & Translational Development, the Senior Director will drive program-level toxicology strategy from target selection and lead optimization through IND-enabling activities, clinical advancement, and NDA submission, with a particular focus on CNS small molecules. The successful candidate will work independently to direct their own program work, provide day-to-day scientific guidance to entry-level toxicology staff, and collaborate closely with peers across nonclinical and development functions. The Senior Director will own design, oversight, and interpretation of toxicology and safety pharmacology studies executed at CROs and will author the toxicology contributions to global regulatory submissions.
Centessapharmaceuticalsinc · Boston, MA