Executive Director, Toxicology

Lilly • Indianapolis, IN

6d • $153,000 - $290,400 • Hybrid

About The Position

Centessa Pharmaceuticals, a wholly subsidiary of Eli Lilly and Company 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. Centessa Pharmaceuticals is seeking an Executive Director, Toxicology to provide scientific and strategic leadership as well as operational management for nonclinical safety across discovery and development programs, with an emphasis on small‑molecule therapeutics. This role leads toxicology and safety pharmacology strategy to support target selection, lead optimization, IND/NDA enabling activities. Reporting to our Head of Nonclinical & Translational Development, the Executive Director partners closely with cross‑functional teams and represents nonclinical safety in regulatory interactions while building a strong, high‑performing toxicology organization.

Requirements

• PhD in Toxicology, Pharmacology, Pathology, DVM, or related discipline; board certification (e.g., DABT, ERT) preferred
• 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 PDTs at governance, engage confidently with regulatory agencies, and serve as a trusted development partner to senior leadership.
• Deep expertise supporting small‑molecule programs across discovery, IND‑enabling, 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

Nice To Haves

• board certification (e.g., DABT, ERT) preferred

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 cross‑functional development teams
• Lead nonclinical sub‑teams as an integrated development head, providing cross‑functional 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, non‑GLP, 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., pre‑IND, 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree