Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Senior Director, Toxicology (CNS Specialist)

Boston, MA · Director · Full-time

Sponsorship not specified$250k-$270kDetected 6 days ago
CompliancePharmacologyFDA RegulatoryScientific WritingLeadershipCommunicationMentoringWriting

About the role

  • Description of Role Centessa is seeking a Senior Director, Toxicology to provide scientific and technical leadership for nonclinical safety in our CNS programs.
  • Work Location The Senior Director, Head of Toxicology role is a remote role based in the US, with regular travel (up to 25%-30%).
  • We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Responsibilities

  • 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.
  • Author and critically review the toxicology sections of global regulatory documents, including pre-IND packages, INDs, CTAs, IBs, DSURs, and NDA submissions.
  • 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.
  • Work independently to plan, prioritize, and deliver on program toxicology objectives.

Requirements

  • 12+ years of pharmaceutical or biotechnology R&D experience with a strong track record in nonclinical and regulatory toxicology, including 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.
  • Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform development decisions.
  • Sense of urgency, detail orientation, and ability to thrive in a hands-on, growth stage environment.
  • PhD in Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related discipline
  • board certification (e.g., DABT, ERT).
  • 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.
  • Proven ability to work independently, set priorities, and deliver high-quality program output without close supervision, while collaborating effectively with peers across functions.
  • Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents.

Compensation

  • The annual base salary range for this position is 250,000.00 to $270,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
  • In addition to base pay, this role is eligible for a discretionary annual bonus.

Benefits

  • Prepare science-based written responses to nonclinical inquiries from health authorities (FDA, EMA, and other global regulators).

Company info

  • Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company 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.
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