Toxicology Study Director

Role & responsibilities

• Serve as Study Director in compliance with GLP regulations (OECD, USFDA, EU EMA guidelines).
• Design, plan, execute, and oversee preclinical toxicology studies, primarily in rodent models (rats/mice) and also in non-rodents.
• Ensure effective conduct of studies including:
• Sub-acute, sub-chronic, and chronic toxicity studies
• Toxicokinetics (TK)
• MTD/Dose range finding studies
• Act as the single point of study control, ensuring integrity and scientific quality of data.
• Prepare, review, and finalize study protocols, amendments, and reports in compliance with regulatory requirements.
• Author and submit GLP-compliant study reports for regulatory filings (e.g., US FDA, EMA/EU submissions).
• Provide scientific interpretation of toxicological findings and risk assessment.
• Collaborate with cross-functional teams including:
• Pathology
• Analytical/TK
• Formulation
• Participate in client interactions, study discussions, and audits.
• Support regulatory inspections (USFDA, MHRA, EMA, etc.) and respond to queries.
• Ensure compliance with SOPs, GLP standards, and animal welfare regulations.
• Mentor and guide junior scientists and study personnel.

Preferred candidate profile

• Strong knowledge of preclinical toxicology principles, especially in rodent models.
• Hands-on experience with GLP toxicology studies in a CRO environment.
• Thorough understanding of:
• OECD guidelines
• ICH guidelines (M3, S and Q series)
• USFDA and EMA regulatory requirements
• Expertise in Provantis, data analysis, interpretation, and reporting of toxicological endpoints.
• Familiarity with toxicokinetics and bioanalytical data interpretation.
• Strong documentation and technical writing skills for regulatory submissions.
• Experience handling regulatory audits and inspections.
• Excellent communication and client-facing skills.
• Ability to manage multiple studies and timelines efficiently.

Qualifications

• PhD / MPharm / MSc in Toxicology, Pharmacology, Life Sciences, or related field.
• Certification in ERT or DABT (preferred).