Job Description

Executive Director, Nonclinical Safety & Toxicology

Position Overview

We are seeking a distinguished scientific leader to serve as Executive Director of Nonclinical Safety and Toxicology. This individual will shape and drive the organization's preclinical safety vision across a pipeline of innovative therapeutics, ensuring that safety programs are scientifically rigorous and positioned to support regulatory milestones from early development through commercialization.

The successful candidate brings board-certified expertise in toxicology, a command of global regulatory frameworks, and the leadership acumen to build and inspire high-performing teams in a dynamic biotechnology environment.

Key Responsibilities

Preclinical Safety Strategy Drive the design and execution of comprehensive nonclinical safety programs aligned with pipeline stage and therapeutic area needs. Provide scientific oversight on dose selection, target organ toxicity evaluation, and translational risk interpretation. Establish phase-appropriate safety packages to support first-in-human applications and subsequent regulatory filings.

Regulatory Engagement & Scientific Authority Own toxicology sections of major regulatory submissions and lead scientific responses to health authority queries. Engage directly with global agencies including FDA, EMA, and PMDA on nonclinical matters. Champion adherence to GLP standards, ICH guidelines, and evolving global regulatory expectations.

Study Management & External Collaborations Direct the planning, conduct, and scientific interpretation of a full spectrum of toxicology studies — including general toxicology, genetic toxicology, reproductive and developmental safety, safety pharmacology, and carcinogenicity assessments. Build and steward CRO and vendor partnerships to deliver studies on time, within budget, and to the highest quality standards. Integrate nonclinical safety findings with DMPK, bioanalytical, pathology, and translational science functions.

Risk Characterization & Program Decision Support Lead nonclinical benefit-risk assessments that inform pipeline advancement decisions, first-in-human dose selection, and clinical dose escalation frameworks. Translate preclinical findings into actionable clinical risk mitigation plans and product labeling strategy.

Team Leadership & Organizational Development Recruit, develop, and lead a team of toxicology professionals. Champion scientific mentorship, individual growth, and succession planning. Cultivate a culture defined by intellectual rigor, transparency, and collaborative excellence.

Enterprise-Wide Partnership Collaborate closely with Clinical Development, Regulatory Affairs, CMC, Translational Medicine, and Medical Affairs to deliver integrated development strategies. Represent the nonclinical safety function on key governance and development committees.

Required Qualifications

• Doctoral degree (PhD) in Toxicology, Pharmacology, or a closely related discipline
• Active DABT certification or equivalent recognized board credential
• 15 or more years of industry experience in toxicology and nonclinical drug development within pharmaceutical or biotechnology organizations
• Demonstrated success leading toxicology teams and managing external research partners
• Substantial experience supporting IND/CTA filings and direct regulatory agency interactions
• Documented track record of advancing drug candidates from discovery through clinical stages
• Ability to travel domestically and internationally up to approximately 20% of the time
• Must be authorized to work in the United States

Preferred Qualifications

• Prior executive or senior leadership title (Senior Director, Executive Director, or VP) within a Toxicology or Preclinical Safety function
• Therapeutic area depth in oncology, rare disease, neurology, immunology, or similar specialty areas
• Experience contributing to an early-stage or company-building biotech environment
• Familiarity with emerging modalities such as RNA therapeutics, gene therapy, biologics, or antibody-drug conjugates

Core Competencies

Regulatory toxicology expertise · Translational safety · Strategic risk assessment · Scientific communication at the executive level · Cross-functional influence · People leadership and mentoring · Comfort in fast-paced, matrixed organizations

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