Executive Director, Toxicology

BioSpace; Indianapolis (IN); On-site; USD 153,000 - 290,000; Full time

Benefits offered by this job

Company bonus

401(k) plan with matching

Job summary

Lilly is seeking an Executive Director, Toxicology to provide scientific and strategic leadership across nonclinical safety for small‑molecule programs. This US‑based role leads toxicology and safety pharmacology strategy to support target selection and IND/NDAs, reporting to the Head of Nonclinical & Translational Development.

You will partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues to drive integrated decision‑making, supervise studies, and ensure

Qualifications

• PhD in toxicology or related discipline; board certification preferred.
• 18+ years in pharma/biotech R&D with nonclinical/regulatory toxicology.
• Experience leading toxicology teams and engaging with health authorities.

Responsibilities

• Lead and mentor a team of toxicologists and staff.
• Define and execute nonclinical safety strategies across stages.
• Provide toxicology input to cross-functional development teams.
• Oversee GLP and non-GLP toxicology studies and CROs.
• Present nonclinical safety data to leadership and regulators.

Skills

Nonclinical leadership

Regulatory interactions

GLP knowledge

Education

PhD in Toxicology/Pharmacology/Pathology/DVM

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Description Of Role

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.

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 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

Qualifications

• 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

Work Location

The Executive Director, Toxicology role is based in the US, with occasional travel.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

• Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
• $153,000 - $290,400
• Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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