Nonclinical Development Scientist (Toxicology / DMPK)

Key Responsibilities

• Plan and design nonclinical studies, including toxicology and pharmacokinetics (PK/DMPK)
• Manage, coordinate, and oversee nonclinical studies conducted by domestic and international CROs
• Analyze nonclinical data and prepare study reports and regulatory documents

Qualifications

• Education: Master’s degree or higher in Pharmacy, Veterinary Medicine, Toxicology, or a related life science field
• Experience: Minimum 5 years of hands-on experience in nonclinical studies (toxicology and/or pharmacokinetics) (Entry-level candidates are not eligible)

Required Competencies

• Experience conducting nonclinical studies for antibody and/or protein-based therapeutics
• Hands-on experience in antibody/protein drug development
• Strong understanding of GLP and relevant domestic and international regulatory guidelines (e.g., ICH)

Preferred Qualifications

• Experience preparing and submitting nonclinical study reports for IND applications
• Certified toxicologist
• Ability to communicate and collaborate with overseas CROs and regulatory authorities
• Experience as a project leader for antibody/protein programs at domestic or global pharmaceutical companies
• Experience supporting CMC-related activities for antibody/protein development projects

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