Senior Director, Toxicology

Job Description

Job Description

The Senior Director of Toxicology provides strategic and scientific leadership for all nonclinical safety assessment activities across the company’s drug discovery and early development portfolio (preclinical through Phase 1). This individual is responsible for designing and overseeing toxicology programs that enable regulatory submissions and support safe progression of candidates into human clinical trials. The role requires close collaboration with cross-functional teams and external partners (CROs), with a strong emphasis on scientific rigor, regulatory compliance, and efficient execution.

Essential Duties and Responsibilities:

• Toxicology Leadership

• Develop and implement integrated nonclinical safety strategies to support IND-enabling studies and early clinical development
• Serve as the internal subject matter expert in toxicology
• Provide risk assessment and mitigation strategies for candidate selection and development
• Manage toxicology budgets and timelines across multiple programs
• Partner with discovery, clinical, and regulatory teams to contribute safety considerations for target selection, candidate optimization, and development plans
• Support translational strategies linking nonclinical findings to clinical outcomes

• Toxicology Program Oversight

• Design, oversee, and interpret toxicology studies, including:

• Non-GLP and GLP single-dose and repeat-dose toxicity studies
• Safety pharmacology studies
• IND-enabling and post-IND toxicology studies, including genotoxicity, phototoxicity, reproductive, and/or developmental toxicology studies, as needed
• Toxicokinetic assessments
• Vendor and CRO Management

• Select and oversee CROs conducting toxicology and safety studies
• Build and maintain strong relationships with external partners, ensuring high-quality data generation
• Monitor study timelines, budgets, and quality for successful delivery of results

• Regulatory Support

• Author and review nonclinical sections of regulatory documents, including INDs, briefing packages, and investigator brochures
• Serve as toxicology expert in interactions with regulatory agencies
• Ensure studies comply with GLP and other relevant regulatory guidelines

Preferred Experience and Qualifications:

• Ph.D., D.V.M., or equivalent in Toxicology, Pharmacology, or a related discipline
• 12+ years of relevant experience in the pharmaceutical or biotechnology industry, with a preference for small biotech experience
• Demonstrated experience supporting IND submissions and early clinical development (Phase 1)
• Deep knowledge of US and ex-US regulatory toxicology requirements (FDA, ICH, etc.)
• Experience designing and interpreting a wide range of nonclinical safety studies
• Strong understanding of toxicokinetics and translational safety assessment
• Proven ability to lead programs and influence cross-functional teams
• Experience managing external CROs and complex outsourced studies
• Excellent written and verbal communication skills, with experience in regulatory writing
• Strong organizational and project management skills
• Experience with toxicology and regulatory requirements for pediatric and rare disease indications for new chemical entities preferred
• Experience interacting directly with regulatory agencies preferred
• Experience managing both oncology and non-oncology toxicology preferred

About OnKure:

We are a clinical-stage biopharmaceutical company focused on discovering and developing precision medicines that target biologically validated drivers of diseases underserved by available therapies. Using a structure- and computational chemistry-driven drug design platform, we are committed to improving clinical outcomes for patients by building a robust pipeline of small-molecule drugs designed to selectively target specific mutations thought to be key drivers of cancer and vascular anomalies.

To attract the very best talent, OnKure offers a generous compensation and benefits package that includes competitive pay, performance-based bonus opportunities, stock options, insurance coverage (health, dental, life, and disability) for full-time employees, self-managed paid time off, and a 401(k) plan with company match. Candidates who live in or are willing to relocate to the Boulder, CO area are preferred.

The annual compensation range for this role, based on experience, is $280,000 - $300,000.

OnKure is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, protected veteran status, disability, or any other protected factors.