Study Director – Toxicology

Eurofins; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Eurofins Advinus in Bengaluru, India, seeks a Study Director – Toxicology to design, conduct, and oversee non-clinical safety studies (GLP and non-GLP) to support drug development and regulatory submissions. You will provide scientific leadership, ensure regulatory compliance, manage studies, and collaborate cross-functionally to maintain data integrity and high-quality reports.

Qualified candidates hold a Ph.D.

Qualifications

• Experience in repeat-dose toxicity, teratology, and reproductive toxicity studies.
• Understanding of pharmaceutical R&D and agrochemical testing processes.
• Strong knowledge of GLP and relevant regulatory guidelines.
• Proven experience as a Study Director or in an equivalent role within a CRO or pharmaceutical organization.
• Strong scientific writing and communication skills.
• Ability to lead teams and manage multiple projects simultaneously.
• Proficiency in data analysis and scientific interpretation.
• Strong team-working and cross-functional collaboration skills.

Responsibilities

• Design, conduct, oversee, and report non-clinical safety studies (GLP and non-GLP).
• Provide scientific leadership and ensure regulatory compliance.
• Lead study management and cross-functional collaboration to ensure data integrity.
• Maintain high-quality study reports and timely regulatory submissions.

Skills

Repeat-dose toxicity

Teratology

Reproductive toxicity

GLP knowledge

CRO/pharma experience

Scientific writing

Team leadership

Project management

Data analysis

Cross-functional collaboration

Education

Ph.D./Master's in Veterinary Sciences/Biosciences

Job description

Company Description

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.

With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.

Position: Study Director – Toxicology

Role Overview

The Study Director – Toxicology will be responsible for designing, conducting, overseeing, and reporting non-clinical safety studies (GLP and non-GLP) to support drug development and regulatory submissions. The role involves scientific leadership, regulatory compliance, study management, and cross-functional collaboration to ensure the quality and integrity of toxicology studies.

Key Skills & Experience

• Experience in repeat-dose toxicity, teratology, and reproductive toxicity studies/processes.
• Understanding of pharmaceutical R&D and agrochemical testing processes.
• Strong knowledge of GLP and relevant regulatory guidelines.
• Proven experience as a Study Director or in an equivalent role within a CRO or pharmaceutical organization.
• Strong scientific writing and communication skills.
• Ability to lead teams and manage multiple projects simultaneously.
• Proficiency in data analysis and scientific interpretation.
• Strong team-working and cross-functional collaboration skills.

Behavioral Competencies

• Excellent oral and written communication skills.
• Flexibility to work effectively in a dynamic environment.
• Effective time and project management skills.
• Takes ownership of responsibilities and demonstrates a commitment to continuous learning and improvement.
• Well-organized, structured, and efficient approach to work.

Qualifications

• Qualification: Ph.D./Master's in Veterinary Sciences, Biosciences, or related disciplines.