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Executive Director, Head of Toxicology

Crains Cleveland

Centessa Pharmaceuticals is seeking an Executive Director/Head of Toxicology to provide scientific and strategic leadership for nonclinical safety across discovery and development programs, with an emphasis on smallmolecule therapeutics. This role leads toxicology and safety pharmacology strategy to support target selection, lead optimization, INDenabling activities, and clinical advancement. Reporting to our SVP, Nonclinical & Translational Development, the Head of Toxicology partners closely with crossfunctional teams and represents nonclinical safety in regulatory interactions while building a strong, highperforming toxicology organization. Key Responsibilities Lead and mentor a team of toxicologists and technical/operational staff, fostering scientific excellence and professional growth Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages Provide expert toxicology and safety pharmacology input to crossfunctional development teams Lead nonclinical subteams as an integrated development head, providing crossfunctional oversight across Toxicology, DMPK, Bioanalytical Sciences, and Clinical Pharmacology to ensure aligned, program-ready nonclinical strategies Serve as the primary nonclinical representative on Program Development Teams (PDTs) and at internal governance and external forums, effectively championing program strategy, presenting to regulatory authorities, and holding scientific ground with senior leadership, partners, CROs, and health authorities Design, oversee, and interpret GLP, nonGLP, investigative, and in vitro toxicology studies Develop safety strategies for new targets, lead optimization programs, and platform technologies Oversee toxicology and safety pharmacology studies conducted internally and at CROs Ensure high scientific quality, compliance, and timely delivery of nonclinical study outputs Author and critically review toxicology sections of regulatory documents (e.g., preIND, IND, IBs) Partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues to drive integrated decision‑making Present nonclinical safety data and risk assessments to project teams and senior R&D leadership Serve as the primary nonclinical safety representative in regulatory agency interactions Support product defense and regulatory submissions through robust scientific rationale Provide strategic guidance on safety issue resolution and investigational toxicology approaches Contribute to portfolio‑level planning and prioritization of nonclinical safety resources Build scalable toxicology capabilities to support a growing and diverse pipeline Qualifications PhD in Toxicology, Pharmacology, Pathology, DVM, or related discipline; board certification (e.g., DABT, ERT) - required 18+ years of experience in pharmaceutical or biotechnology R&D with a strong track record in nonclinical and regulatory toxicology Proven ability to function as an upward‑facing nonclinical leader and generalist, with the credibility and judgment to represent project development team agenda at decisional governance meetings, engage confidently with regulatory agencies, and serve as a trusted development partner to senior leadership Deep expertise supporting small molecule programs across discovery, INDenabling, and early clinical development Strong working knowledge of national and international GLP guidelines Demonstrated experience defining and executing nonclinical safety strategies to support diverse pipelines and novel biology Proven leadership experience building, managing, and mentoring toxicology teams within a collaborative, matrixed environment Extensive experience preparing and reviewing nonclinical sections of global regulatory submissions and engaging with health authorities (FDA, EMA) Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform development decisions Experience overseeing outsourced toxicology and safety pharmacology studies and managing CRO partnerships Excellent communication and influencing skills, with the ability to partner effectively across Early Development, Research, and Regulatory functions in a fast‑paced environment #J-18808-Ljbffr Crains Cleveland

Vacancy posted 4 days ago
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