Director, Toxicology

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Toxicology based in United States.

This role offers the opportunity to provide scientific leadership and strategic toxicology expertise within the drug development ecosystem. The position focuses on guiding non-clinical development strategies, supporting regulatory submissions, and advancing safe and effective therapies. You will collaborate with multidisciplinary teams, including pharmacologists, statisticians, modelers, and drug development specialists, to deliver high-impact solutions for complex programs. The ideal candidate will bring deep expertise in applied toxicology, strong regulatory knowledge, and experience supporting diverse therapeutic areas. This position requires a strategic thinker who can independently lead projects, advise clients, and translate scientific data into actionable development decisions. You will play a key role in shaping safety assessment strategies and supporting successful outcomes across innovative pharmaceutical programs.

Accountabilities:: The Director, Toxicology will serve as a recognized scientific expert responsible for providing toxicology leadership across drug development projects. This role involves collaborating with internal teams and external stakeholders to evaluate safety data, support regulatory strategies, and guide non-clinical development decisions.

Provide expert toxicology guidance to support non-clinical and clinical development plans, safety assessments, and drug development strategies.

Lead due diligence activities and perform gap analyses of non-clinical data packages to identify risks and opportunities.

Design toxicology programs supporting regulatory milestones, including IND, NDA/BLA submissions, and post-registration studies.

Develop study strategies and collaborate with clients to identify appropriate CRO partners and oversee study execution, data analysis, and reporting.

Prepare and contribute to regulatory documentation, including non-clinical sections for submissions and responses to regulatory inquiries.

Design investigative approaches to evaluate toxicology findings and determine their relevance to human safety.

Represent project teams in discussions with regulatory authorities when required.

Serve as the toxicology lead on cross-functional drug development teams, partnering with experts across pharmacology, clinical development, and related disciplines.

Provide scientific oversight and mentorship to associates and junior team members when applicable.

Support client and alliance relationships through clear communication, strategic recommendations, and scientific expertise.

Influence best practices in pharmacology and toxicology within the broader drug development environment.

Requirements:

The ideal candidate will possess advanced toxicology expertise, pharmaceutical development experience, and the ability to lead complex scientific initiatives while collaborating effectively with diverse stakeholders.

PhD in Pharmacology, Toxicology, or a related scientific field.

Minimum of 4–6 years of post-degree experience within a drug development company, consulting organization, CRO, regulatory agency, or similar environment.

Experience supporting at least three non-clinical development programs involving small molecules, biologics, gene therapies, RNA-based therapies, proteins, or related modalities.

Strong knowledge of toxicology principles, safety pharmacology, and regulatory expectations for drug development.

Experience designing and outsourcing GLP and non-GLP toxicology and safety pharmacology studies.

Proven ability to address questions and feedback from global regulatory agencies.

Experience authoring non-clinical sections of IND, NDA, and BLA submissions.

Background supporting multiple therapeutic areas such as oncology, CNS, inflammation, metabolic disease, or cardiovascular programs.

Ability to develop safety margins based on non-clinical toxicity findings and clinical exposure data.

Strong project management skills with the ability to prioritize multiple initiatives.

Excellent written, verbal, and interpersonal communication skills.

Ability to lead cross-functional teams and collaborate with scientific and business stakeholders.

Strong client management, relationship-building, and consulting skills.

Proficiency with Microsoft Word, PowerPoint, and other business productivity tools.

Board certification in toxicology or a related credential is preferred.

Benefits:

Opportunity to contribute to innovative pharmaceutical and biotechnology development programs.

Ability to work with multidisciplinary teams of scientific and drug development experts.

Exposure to diverse therapeutic areas and complex global projects.

Professional growth opportunities through collaboration and leadership responsibilities.

Flexible work environment supporting remote work opportunities.

Competitive compensation package based on experience and qualifications.

Opportunity to influence safety strategies for next-generation therapies.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1