About Our Client

Our client is an innovative, research-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapeutics. The company is committed to delivering safe, effective, and accessible treatment solutions to patients worldwide. With a strong focus on oncology, immunology, metabolic disorders, and other serious diseases, the organization has established a fully integrated R&D platform spanning drug discovery, preclinical research, and clinical development. As its innovative pipeline continues to expand, the company is seeking an experienced Toxicology expert with a global mindset and extensive new drug development experience to help advance its next generation of innovative therapies.

About the Job

• Lead the overall planning and execution of nonclinical safety assessment strategies for innovative drug development programs.
• Develop toxicology strategies in compliance with NMPA, FDA, EMA, and ICH regulatory requirements and guidelines.
• Establish, maintain, and continuously optimize the company's toxicology capabilities, technical platforms, and management systems.
• Oversee and coordinate a wide range of toxicology studie
• Review and approve toxicology study protocols, study reports, risk assessments, and other related scientific documentation
• Lead the preparation, review, and submission of toxicology sections for IND, CTA, and NDA applications
• Provide scientific interpretation of key toxicological findings and assess translational safety risks.
• Participate in candidate selection (PCC) and critical R&D decision-making processes.
• Serve as the toxicology subject matter expert and provide strategic support to Drug Discovery, DMPK, CMC, and Clinical Development teams.
• Perform benefit-risk assessments and support project milestone and portfolio decisions.
• Develop and implement safety risk management strategies to support clinical development from Phase I through late-stage clinical programs.

Qualifications

• Ph.D. degree in Toxicology, Pharmacology, Medicine, Veterinary Medicine, Biology, or a related life sciences discipline.
• Overseas education and/or experience with multinational pharmaceutical companies is highly preferred.
• Minimum of 10 years of experience in nonclinical safety assessment within innovative drug development.
• At least 5 years of people management and toxicology team leadership experience.
• Proven track record of successful IND submissions for innovative drug programs.
• Experience with toxicology development strategies for emerging therapeutic modalities and innovative treatments.
• In-depth knowledge of toxicology regulations and guidance documents issued by ICH, FDA, EMA, and NMPA.
• Strong expertise in toxicology, safety pharmacology, and nonclinical risk assessment.
• Thorough understanding of GLP regulations and quality management systems.
• Demonstrated ability to independently author, review, and approve scientific and regulatory documents in English.
• Strong scientific judgment and strategic thinking in drug development.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Ability to effectively manage multiple projects and priorities in a fast-paced R&D environment.
• Strong problem-solving skills and the ability to influence decision-making at both project and organizational levels.
• Proficiency in both written and spoken English, with the ability to communicate effectively in global regulatory and scientific settings.