Key Responsibilities and Required Skills for a Toxicology Supervisor

🎯 Role Definition

A Toxicology Supervisor is a seasoned scientific leader who steers the strategic and operational direction of a toxicology team. This individual serves as the cornerstone for non-clinical safety evaluation, blending deep technical expertise with strong management skills. You'll be responsible for the design, execution, and interpretation of toxicology studies, ensuring they meet rigorous scientific standards and global regulatory requirements (e.g., GLP, FDA, EMA). More than just a scientist, the Toxicology Supervisor is a mentor, a project manager, and a key strategic partner in cross-functional teams, guiding programs from early discovery through to regulatory submission and market approval. Your leadership will directly impact the safety assessment of new therapeutics or chemicals, making this a role with significant responsibility and influence.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Toxicologist / Principal Scientist
Study Director (Toxicology)
Senior Research Investigator (Pathology/Toxicology)

Advancement To:

Manager / Senior Manager, Toxicology
Associate Director, Non-clinical Safety Assessment
Director, Preclinical Development

Lateral Moves:

Project Manager, Toxicology Programs
Regulatory Affairs Specialist/Manager (CMC/Non-clinical)

Core Responsibilities

Primary Functions

Act as a Study Director and/or Study Monitor for a variety of non-clinical toxicology studies (GLP and non-GLP), taking ultimate responsibility for the scientific integrity, compliance, and timely execution of the studies.
Provide direct line management, scientific leadership, and mentorship to a team of junior and senior toxicologists, technicians, and study coordinators, fostering their professional growth and development.
Design and develop robust, scientifically sound study protocols for in-vivo and in-vitro toxicology studies that align with program objectives and global regulatory expectations.
Critically review, interpret, and synthesize complex toxicology and toxicokinetic data sets, contextualizing findings to provide clear, concise risk assessments and impact analyses.
Author, review, and approve comprehensive study reports, ensuring they are of high quality, scientifically accurate, and delivered within established timelines.
Serve as the primary toxicology subject matter expert on multidisciplinary project teams, providing strategic guidance on non-clinical safety assessment from early discovery through post-marketing.
Lead the preparation and review of the non-clinical safety sections of regulatory submission documents, including Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA) filings.
Ensure all laboratory and study-related activities are conducted in strict compliance with Good Laboratory Practice (GLP) regulations, internal SOPs, and animal welfare guidelines (IACUC/AALAC).
Function as the main point of contact for external partners, including Contract Research Organizations (CROs), managing study placement, monitoring progress, and ensuring quality and timeline adherence.
Proactively identify, troubleshoot, and resolve scientific, technical, and regulatory issues that arise during the lifecycle of a toxicology study.
Develop and manage departmental budgets, resource allocation, and project timelines to ensure efficient operation and achievement of corporate goals.
Represent the company and present scientific findings at regulatory agency meetings, scientific conferences, and in peer-reviewed publications.
Oversee the health and welfare of animals used in research, ensuring all work is ethically performed and compliant with all applicable animal welfare regulations.
Stay abreast of emerging toxicological methodologies, new technologies, and evolving global regulatory landscapes to ensure the department's practices remain state-of-the-art.
Lead or contribute to departmental initiatives, such as the development and validation of new assays, revision of Standard Operating Procedures (SOPs), and implementation of process improvements.

Secondary Functions

Support ad-hoc data requests and conduct exploratory data analysis to investigate novel safety signals or support business development due diligence.
Contribute to the organization's overarching non-clinical development strategy and departmental roadmap by providing expert toxicological insights.
Collaborate with business units, including discovery, clinical development, and regulatory affairs, to translate program needs into actionable toxicology plans.
Participate actively in departmental meetings, sprint planning sessions, and other agile ceremonies to drive project momentum and team alignment.
Provide training to cross-functional colleagues on toxicology principles and the interpretation of non-clinical safety data.
Review and provide expert input on non-clinical sections of external-facing documents, such as investigator brochures and product labels.

Required Skills & Competencies

Hard Skills (Technical)

GLP Expertise: Deep, practical knowledge of Good Laboratory Practice (GLP) regulations as they apply to non-clinical safety studies for FDA, EMA, and other global health authorities.
Study Direction: Proven experience serving as a Study Director or Study Monitor, demonstrating end-to-end management of toxicology studies from protocol design to final report.
Toxicological Risk Assessment: Ability to interpret complex data sets, identify safety signals, and perform comprehensive risk assessments to inform project decisions.
Regulatory Document Authoring: Demonstrated skill in writing and reviewing non-clinical sections of major regulatory filings (e.g., INDs, NDAs, IB).
In Vivo & In Vitro Methodologies: Broad understanding of a wide range of toxicology study types, including general, genetic, reproductive, and developmental toxicology, as well as safety pharmacology.
Toxicokinetics (TK) / Pharmacokinetics (PK): Solid understanding of TK/PK principles and the ability to integrate exposure data into the interpretation of toxicology findings.
Scientific Software Proficiency: Competence with data analysis and reporting software such as Pristima, SENDdite, GraphPad Prism, and Microsoft Office Suite.

Soft Skills

Leadership and Mentorship: A natural ability to lead, inspire, and develop a team of scientific professionals, fostering a collaborative and high-performing culture.
Exceptional Communication: The capacity to articulate complex scientific concepts clearly and concisely to both technical and non-technical audiences, both verbally and in writing.
Critical Thinking & Problem-Solving: A proactive and analytical approach to identifying challenges, evaluating options, and implementing effective solutions in a fast-paced environment.
Project Management: Strong organizational skills with the ability to manage multiple complex projects simultaneously, balancing priorities, timelines, and resources effectively.
Cross-Functional Collaboration: A team-player mindset with a proven ability to work constructively with colleagues from diverse functions like chemistry, biology, clinical, and regulatory affairs.
Meticulous Attention to Detail: An unwavering commitment to accuracy and quality in all aspects of work, from data review to report finalization.

Education & Experience

Educational Background

Minimum Education:

Master of Science (M.S.)

Preferred Education:

Doctor of Philosophy (Ph.D.) or Doctor of Veterinary Medicine (D.V.M.)
Board Certification in Toxicology (e.g., DABT) is highly desirable.

Relevant Fields of Study:

Toxicology
Pharmacology
Veterinary Medicine
Pathology
Related Biological or Life Science

Experience Requirements

Typical Experience Range:

8-15 years of relevant, post-degree experience in the field of toxicology.

Preferred:

A minimum of 8 years of hands-on experience in a pharmaceutical, biotechnology, or Contract Research Organization (CRO) environment. At least 3 of these years should include direct experience in a supervisory, team-lead, or management capacity, demonstrating a track record of leading scientific staff and projects.