Director/Sr Director, Toxicology

Director / Senior Director, Toxicology

About the Company

This role is with a rapidly expanding, clinical‑stage biopharmaceutical company developing innovative small‑molecule therapies for significant unmet needs in neuroscience and related conditions. Supported by strong investors and an advancing discovery and development pipeline, the organization is committed to rigorous science, operational excellence, and impactful collaboration.

Why Join

You will be part of a mission‑focused R&D organization where scientific insight and cross‑functional teamwork directly influence program success. This environment values transparency, high‑velocity execution, and thoughtful problem‑solving. In this role, you will partner closely with Discovery, Nonclinical, and Clinical Development teams to help guide assets from early research through IND‑enabling studies. Your contributions will have a meaningful impact on the trajectory of the company's development programs.

Responsibilities

As the nonclinical function grows, the company is seeking a senior toxicology leader to oversee outsourced toxicology studies supporting small‑molecule discovery and development programs.

Strategic Toxicology Leadership

• Collaborate with project teams and external experts to define toxicology strategies aligned with program objectives.
• Provide guidance on nonclinical study design, timelines, and regulatory expectations for development candidates.

Study Oversight & Execution

• Manage GLP and non‑GLP toxicology studies conducted at Contract Research Organizations (CROs).
• Participate in CRO selection and ensure proper oversight across all stages of study execution.
• Design and direct investigative toxicology studies based on mechanistic hypotheses and candidate safety profiles.
• Ensure studies are conducted accurately, efficiently, and in compliance with quality expectations.
• Review raw data, audit for accuracy, and finalize study reports to support regulatory submissions.
• Identify and resolve study‑related issues in real time through effective CRO partnership.

Regulatory & Cross‑Functional Support

• Prepare written and verbal summaries for internal discussions and decision‑making.
• Contribute to or author nonclinical sections of regulatory documents (e.g., pre‑IND packages, INDs, Investigator's Brochures).
• May participate in meetings with regulatory authorities.
• Present toxicology data and program updates to cross‑functional teams and senior leadership.

Education & Experience

• Bachelor's degree in toxicology, pharmacology, or related scientific discipline; advanced degree a plus.
• Extensive experience in toxicology and small‑molecule development within biotech or pharma.
• Experience as a study director or similar role at a CRO is beneficial.
• Expertise in toxicology and/or toxicologic pathology, including design and interpretation of exploratory and GLP toxicology studies.
• Strong communication skills with the ability to convey complex concepts clearly.
• Demonstrated ability to collaborate effectively across multidisciplinary teams.
• Excellent interpersonal skills and ability to work with individuals at all organizational levels.

Core Competencies

Adaptability

Responds effectively to change and ambiguity, displaying flexibility, resilience, and a proactive mindset in fast‑moving situations.

Collaboration

Builds strong partnerships across teams, communicates clearly and respectfully, and actively contributes to a positive, inclusive working environment.

Execution

Delivers high‑quality work with urgency and accountability. Proactively addresses challenges, drives continuous improvement, and ensures alignment with program and organizational goals.