Job brief
We are seeking a detail-oriented Toxicologist to join our drug discovery team and play a pivotal role in the safety assessment of our evolving therapeutic pipeline. You will be responsible for designing safety study protocols, reviewing pathology reports, and collaborating with cross-functional project teams to navigate the complexities of international drug safety. This is an exciting opportunity for a scientist to influence key R&D decisions while ensuring our innovations are developed with the highest standards of safety and regulatory integrity. We value scientific rigor, clear technical communication, and a proactive approach to solving complex toxicology challenges.
Key highlights
- Design and oversee non-clinical toxicology study protocols, including dose-ranging and pivotal GLP-compliant safety studies for small and large molecules.
- Analyze and interpret histopathology, clinical chemistry, and hematology datasets to identify potential target organ toxicities early in the drug development lifecycle.
- Author and review critical non-clinical sections of regulatory documents, including IND, NDA, and BLA filings for FDA, EMA, and PMDA submissions.
- Evaluate potential impurities and degradants using QSAR software and extractables/leachables analysis to ensure compliance with ICH M7 and Q3 guidelines.
What is a Toxicologist?
A Toxicologist is a specialized life scientist responsible for evaluating the safety and biological impact of drug candidates throughout the discovery and development lifecycle. Working within complex regulatory frameworks, a Toxicologist identifies potential hazards using advanced in vitro and in vivo testing models, histopathology, and toxicokinetics data. Their expertise is foundational to mitigating clinical risk, securing IND/NDA approvals, and ensuring that life-saving therapies meet rigorous safety standards before human testing begins.
What does a Toxicologist do?
A Toxicologist designs and oversees non-clinical safety studies, interprets complex laboratory datasets, and authors critical sections of regulatory filings such as the Investigator's Brochure. They collaborate with pharmacology, pharmacokinetics, and clinical teams to translate toxicological findings into actionable development strategies. Using software like SAS or R for data analysis and specialized toxicology databases, they monitor adverse findings and prepare technical reports that determine whether a drug candidate proceeds to clinical trials.
Key responsibilities
- Design and oversee non-clinical toxicology study protocols, including dose-ranging and pivotal GLP-compliant safety studies for small and large molecules.
- Analyze and interpret histopathology, clinical chemistry, and hematology datasets to identify potential target organ toxicities early in the drug development lifecycle.
- Author and review critical non-clinical sections of regulatory documents, including IND, NDA, and BLA filings for FDA, EMA, and PMDA submissions.
- Collaborate with PK/PD experts to integrate toxicokinetics data, refining dose selection strategies for subsequent clinical trial designs and human dose modeling.
- Evaluate potential impurities and degradants using QSAR software and extractables/leachables analysis to ensure compliance with ICH M7 and Q3 guidelines.
- Manage relationships with Contract Research Organizations (CROs) to ensure study monitoring, data quality, and timely delivery of finalized laboratory reports.
- Present comprehensive toxicology risk assessments to internal project teams and senior management to inform go/no-go decisions for clinical advancement.
- Participate in internal audits and process improvement initiatives to maintain laboratory compliance with current GLP (Good Laboratory Practice) regulations.
Requirements and skills
- PhD in Toxicology, Pharmacology, or a related Life Science field with 3+ years of experience in the pharmaceutical or biotech industry.
- Advanced proficiency in interpreting toxicological data, including histopathology, with a strong grasp of mechanisms of toxicity and target organ impact.
- Demonstrated experience preparing non-clinical documentation for regulatory submissions to agencies like the FDA, EMA, or other global health authorities.
- Expertise in Good Laboratory Practice (GLP) and International Council for Harmonisation (ICH) guidelines relevant to non-clinical safety testing.
- Technical proficiency with data analysis tools such as SAS, R, or GraphPad Prism for handling large-scale biological datasets.
- Certification as a Diplomate of the American Board of Toxicology (DABT) is strongly preferred and highly valued for senior-level contributions.
- Experience managing external CRO partners, including site visits, protocol deviations, and technical oversight to ensure adherence to study objectives.
- Ability to effectively communicate intricate scientific risks to non-toxicologist stakeholders, including clinical leads, project managers, and executive leadership.
FAQs
What does a Toxicologist do in the pharmaceutical industry?
A Toxicologist in the pharmaceutical industry focuses on assessing the safety of new drug candidates before they are tested in humans. They design safety studies to identify potential risks, analyze laboratory data, and interpret findings to understand how a drug might affect organs and tissues. Their work is essential for determining whether a therapeutic candidate is safe enough to proceed through the clinical development pipeline.
What skills are required to become a successful Toxicologist?
A successful Toxicologist needs a deep understanding of pharmacology, pathology, and statistical analysis to interpret experimental results. Key skills include the ability to navigate GLP (Good Laboratory Practice) regulations, technical report writing for regulatory agencies, and the ability to use specialized software for QSAR modeling. Additionally, soft skills like critical thinking, attention to detail, and cross-functional communication are vital for managing relationships with scientists and regulatory bodies.
Who does a Toxicologist work with on a day-to-day basis?
A Toxicologist collaborates with a broad spectrum of professionals, including pharmacologists, medicinal chemists, clinical development teams, and regulatory affairs specialists. They also work closely with external Contract Research Organizations (CROs) to oversee study execution and data collection. By bridging the gap between laboratory results and human clinical strategy, they serve as a core link in the drug development chain.
Why is the role of a Toxicologist important for drug safety?
The role of a Toxicologist is critical because they provide the primary scientific evidence regarding the safety profile of a medicine prior to human exposure. Without their comprehensive risk assessments and identification of toxicities, clinical trials would face significant safety hazards and potential failures. Ultimately, the Toxicologist ensures that only the safest and most promising candidates move forward to become treatments for patients.