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Key Responsibilities and Required Skills for a Toxicologist

💰 $95,000 - $175,000

SciencePharmaceuticalsBiotechnologyResearch & DevelopmentRegulatory Affairs

🎯 Role Definition

The Toxicologist serves as a critical scientific subject matter expert, responsible for evaluating the safety and potential adverse effects of chemical, biological, and physical agents on living organisms and the environment. This role is pivotal in guiding product development, ensuring regulatory compliance, and protecting public health. The Toxicologist applies a deep understanding of toxicological principles to design, manage, and interpret a wide range of safety studies. Working within highly collaborative, cross-functional teams, they provide strategic guidance and expert analysis to ensure that products—from pharmaceuticals and medical devices to consumer goods—meet stringent global safety standards from early discovery through post-market surveillance.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Postdoctoral Fellow (Toxicology, Pharmacology)
  • Associate Scientist (Safety Assessment, Bioanalysis)
  • Research Scientist in a related life sciences field

Advancement To:

  • Senior or Principal Toxicologist
  • Director of Toxicology / Nonclinical Safety
  • Scientific Fellow or Distinguished Scientist

Lateral Moves:

  • Regulatory Affairs Specialist
  • Study Director (at a CRO)
  • Risk Assessment Manager

Core Responsibilities

Primary Functions

  • Serve as the dedicated toxicology subject matter expert on multidisciplinary project teams, providing strategic input and risk assessments for candidate selection, IND/CTA-enabling programs, and lifecycle management.
  • Design, implement, and meticulously manage a comprehensive portfolio of nonclinical toxicology studies (both in vitro and in vivo) conducted at external contract research organizations (CROs) to support development programs from discovery through registration.
  • Function as the Study Monitor for Good Laboratory Practice (GLP) and non-GLP toxicology studies, which includes overseeing protocol development, monitoring study execution, performing data analysis, and ensuring the timely delivery of high-quality final reports.
  • Author and critically review the nonclinical safety sections (e.g., toxicology, pharmacology, pharmacokinetics) of global regulatory submission documents, including Investigational New Drugs (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), and Biologics License Applications (BLAs).
  • Conduct comprehensive human health risk assessments for a variety of substances including impurities, degradants, and extractables/leachables by applying state-of-the-art methodologies to derive health-based exposure limits such as Permitted Daily Exposures (PDEs).
  • Develop and execute integrated nonclinical safety evaluation strategies and testing plans, ensuring they are scientifically sound, efficient, and aligned with current global regulatory expectations and project timelines.
  • Interpret and contextualize complex toxicology and pathology data, effectively communicating key findings, potential risks, and their implications to project teams and senior management to facilitate informed decision-making.
  • Proactively identify, evaluate, and mitigate potential toxicology-related risks for development programs, proposing de-risking strategies and supplemental studies as needed.
  • Prepare clear and concise responses to toxicology-related inquiries from global regulatory health authorities, defending study designs, data interpretation, and safety positions.
  • Maintain up-to-date knowledge of evolving global regulatory guidelines (e.g., FDA, EMA, ICH, OECD) and scientific advancements in the field of toxicology and safety assessment.
  • Represent the toxicology function in interactions with external partners, scientific advisory boards, and potential in-licensing or out-licensing opportunities, providing due diligence and expert evaluation.
  • Act as a key contributor to the design and qualification of novel in vitro and in silico models to reduce, refine, and replace the use of animals (3Rs) in safety testing.
  • Manage the budget, timelines, and contractual aspects of outsourced toxicology studies, ensuring efficient use of resources and strong vendor performance.
  • Provide expert toxicological assessment and support for marketed products, including evaluating post-marketing safety signals, addressing manufacturing issues, and supporting product life cycle changes.
  • Lead or contribute to the development of scientific publications, abstracts, and presentations to communicate significant research findings to the broader scientific community.
  • Mentor junior scientists and team members, fostering their scientific development and understanding of toxicological principles and drug development processes.
  • Critically evaluate toxicology and safety pharmacology data packages for due diligence assessments of external assets for potential acquisition or licensing.
  • Provide strategic nonclinical support for combination products, including medical devices, by assessing biocompatibility and material safety.
  • Develop Target Safety Profiles and other internal safety assessment documents to guide early-stage discovery and development teams.
  • Collaborate closely with related functions such as DMPK, Bioanalytical, Clinical Pharmacology, and Regulatory Affairs to ensure a fully integrated approach to safety evaluation.

Secondary Functions

  • Support ad-hoc data requests and exploratory safety analyses to address emerging project needs or scientific questions.
  • Contribute to the organization's nonclinical safety strategy and the evaluation and implementation of new toxicological assessment technologies and platforms.
  • Collaborate with clinical development, manufacturing, and quality assurance teams to translate product changes and clinical findings into nonclinical safety assessment requirements.
  • Participate in scientific review committees, safety boards, and due diligence teams, providing expert toxicological evaluation and perspective.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep expertise in Good Laboratory Practices (GLP) regulations and their application in a nonclinical setting.
  • Proven ability in nonclinical study design, management, and monitoring of studies conducted at Contract Research Organizations (CROs).
  • Strong working knowledge of global regulatory guidelines for safety assessment (e.g., FDA, EMA, ICH).
  • Experience authoring and reviewing nonclinical sections of major regulatory documents (IND, CTA, NDA/BLA).
  • Proficiency in human health risk assessment methodologies, including the derivation of Permitted Daily Exposures (PDEs) and understanding of Threshold of Toxicological Concern (TTC).
  • Familiarity with data analysis and visualization software (e.g., GraphPad Prism) and toxicology-specific platforms (e.g., SEND, Phoenix WinNonlin).
  • Solid understanding of Drug Metabolism and Pharmacokinetics (DMPK/ADME) principles and their integration with toxicology.
  • Direct experience in a specific toxicology discipline such as genetic toxicology, carcinogenicity, developmental and reproductive toxicology (DART), or immunotoxicology.
  • Ability to critically interpret complex, multi-faceted scientific data sets, including pathology and clinical pathology findings.
  • Project management skills for overseeing outsourced study portfolios, including budget and timeline management.

Soft Skills

  • Exceptional written and verbal communication skills, with the ability to convey complex scientific concepts to both technical and non-technical audiences.
  • Strong analytical and critical thinking capabilities for rigorous, evidence-based problem-solving.
  • Meticulous attention to detail and a commitment to scientific accuracy and integrity.
  • Proven ability to thrive in a collaborative, fast-paced, cross-functional team environment.
  • Excellent organizational and time management skills to manage competing priorities across multiple programs.
  • Strategic mindset with the ability to anticipate future challenges and influence key project decisions.
  • Strong interpersonal skills for building relationships with internal stakeholders and external partners/vendors.

Education & Experience

Educational Background

Minimum Education:

  • Master's degree (M.S.) in Toxicology, Pharmacology, or a closely related scientific discipline.

Preferred Education:

  • Doctorate (Ph.D.) in Toxicology, Pharmacology, Pathology, or a similar field.
  • Board certification, such as Diplomate of the American Board of Toxicology (DABT), is highly desirable and often preferred for senior roles.

Relevant Fields of Study:

  • Toxicology
  • Pharmacology
  • Veterinary Medicine
  • Pathology
  • Biochemistry

Experience Requirements

Typical Experience Range:

  • 5-10+ years of relevant toxicology experience gained within the pharmaceutical, biotechnology, medical device, or chemical industry. Experience at a CRO is also highly relevant.

Preferred:

  • A demonstrated track record of managing the nonclinical safety assessment program for one or more development candidates, coupled with direct experience in the preparation of successful global regulatory submissions.
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