Principal Scientist, Toxicology

CSL; Emea; On-site; IDR 300.000.000 - 400.000.000; Full time

Job summary

A global biotechnology leader in Sulawesi Tengah is seeking a Principal Toxicologist to oversee nonclinical safety strategies. This role involves leading project teams, managing toxicological assessments across drug development, ensuring compliance with GLP and regulatory guidelines, and collaborating with multiple stakeholders. Candidates should have a PhD or equivalent in a related field and 5-8 years of relevant industry experience.

Benefits

Well-being prioritization

Qualifications

• 5-8 years of experience in pharmaceutical or biotech industry.
• Proven track record in nonclinical safety assessment and regulatory submissions.
• Board Certification (ERT or DABT) is a plus.

Responsibilities

• Lead and manage nonclinical safety strategies across multiple drug development projects.
• Compile Toxicological Risk Assessments and nonclinical submission documents.
• Design, oversee, and interpret nonclinical safety studies.

Skills

Nonclinical safety assessment

Regulatory submissions

GLP regulations understanding

Cross-functional collaboration

Leadership

Communication skills

Education

PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field

Job description

Project Toxicology Role: The Principal Toxicologist will lead and manage nonclinical safety strategies across multiple drug development projects. This role serves as the primary toxicology representative on interdisciplinary project teams, will lead the Nonclinical Expert Team (NCET) and provides scientific leadership from early discovery through regulatory submission and market authorization. The role is responsible for the design, adequate budgeting, and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment

Regulatory Toxicology Role: The Principal Toxicologist will compile Toxicological Risk Assessments across multiple drug development projects supporting R&D, CMC and Quality and / or will compile nonclinical submission documents across all projects.

Main Responsibilities

• Serve as the Toxicology representative on cross-functional project teams and act as NCET lead.
• Act as Nonclinical Development representative in Research Project teams.
• Design, oversee, and interpret nonclinical safety studies (GLP and non-GLP) to support regulatory submissions and drug development.
• Develop and implement toxicology strategies aligned with clinical development plans.
• Proactively identify and manage safety risks and liabilities early in development across therapeutic modalities.
• Prepare and review regulatory nonclinical submission documents.
• Collaborate with internal stakeholders including pharmacology, PK, clinical, regulatory, and CMC teams.
• Present integrated safety assessments to senior management and at project milestone reviews.
• Compile toxicological risk assessments for impurities, extractables and leachables, excipients, and other components in line with ICH, EMA, and FDA guidelines.
• Stay current with evolving toxicology guidelines and risk assessment methodologies.

Qualifications and Experience Requirements

• PhD, DVM, or equivalent in Toxicology, Pharmacology, or related field. Board Certification (ERT or DABT) or equivalent is a plus.
• 5-8 years of experience in pharmaceutical or biotech industry.
• Proven track record in nonclinical safety assessment and regulatory submissions.
• Strong understanding of GLP regulations, ICH guidelines, and global regulatory requirements.
• Excellent communication, leadership, and cross-functional collaboration skills.

Experience with CSL’s disease therapeutic areas

Experience across multiple therapeutic areas and modalities is highly desirable.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.