Executive Director, Toxicology

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $153k - $290.4k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• Provide scientific and strategic leadership and operational management for nonclinical safety across discovery and development programs • Lead toxicology and safety pharmacology strategy supporting target selection, lead optimization, and IND/NDA-enabling activities • Lead and mentor toxicologists and technical/operational staff • 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 across Toxicology, DMPK, Bioanalytical Sciences, and Clinical Pharmacology • Represent nonclinical safety on Program Development Teams, internal governance, external forums, and regulatory interactions • Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology studies • Oversee toxicology and safety pharmacology studies conducted internally and at CROs • Ensure scientific quality, compliance, and timely delivery of nonclinical study outputs • Author and critically review toxicology sections of regulatory documents, including pre-IND, IND, and IBs • Partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues • Present nonclinical safety data and risk assessments to project teams and senior R&D leadership • 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 for a growing and diverse pipeline

🎯 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 • 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 for 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, including FDA and EMA • Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology • Experience overseeing outsourced toxicology and safety pharmacology studies and managing CRO partnerships • Excellent communication and influencing skills • Ability to partner effectively across Early Development, Research, and Regulatory functions

🏖️ 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 • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities