Executive Director, Toxicology

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 153,000 - 290,000; Full time

Benefits offered by this job

401(k) plan

Pension

Health, dental, vision benefits

Well-being programs

Job summary

Lilly is seeking an Executive Director, Toxicology to provide scientific and strategic leadership for nonclinical safety across discovery and development programs, focusing on small‑molecule therapeutics. This role leads toxicology strategy, supports IND/IND‑enabling activities, and partners with cross‑functional teams to drive regulatory readiness.

The position reports to the Head of Nonclinical & Translational Development and requires building a high‑performing toxicology organization, with

Qualifications

• PhD in Toxicology, Pharmacology, Pathology, DVM or related field; board certification preferred.
• 18+ years in pharmaceutical/biotech R&D with nonclinical/regulatory toxicology focus.
• Ability to lead nonclinical programs and interact with regulatory authorities.

Responsibilities

• Lead a toxicology and safety pharmacology organization with cross‑functional teams.
• Define nonclinical safety strategies across discovery, preclinical and clinical stages.
• Represent nonclinical safety in regulatory interactions and governance forums.
• Oversee GLP, non‑GLP, investigative and in vitro toxicology studies.
• Manage CRO partnerships and outsource studies to ensure timely outputs.
• Provide strategic guidance on safety resolution and investigational approaches.
• Collaborate with biology, DMPK, pathology, pharmacology, clinical and regulatory teams.

Skills

Toxicology leadership

Regulatory submissions

Cross-functional leadership

GLP knowledge

CRO management

Nonclinical strategy

Education

PhD in Toxicology

Board certification

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 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.

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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