KEY ACCOUNTABILITIES:
The primary responsibilities of a Toxicology Study Director (SD) include designing toxicology study plans, managing project implementation, overseeing quality control, and coordinating team efforts. Specific duties may vary depending on the company's size and project type:
- Plan Development and Project Implementation Responsible for designing and implementing toxicology study plans, including preliminary literature review, technical problem-solving, resource allocation, and client communication, ensuring compliance with regulatory requirements. Must develop reasonable study plans and supervise their execution to ensure the project is completed on time and with quality.
- Quality Control and Data Analysis Conduct scientific analysis of study data, promptly adjust plans, and write study reports. Must establish standard operating procedures (SOPs) to ensure standardized experimental processes and address issues raised by the quality assurance department.
- Team Management and Training Coordinate team member tasks, conduct technical training, and assess performance. Must develop training plans to enhance team professional capabilities and handle emergencies.
- Regulatory Compliance and Submission Support Familiar with GLP standards to ensure study complies with international regulations in the US, Europe, and China. Must guide the preparation of toxicology submission materials to support IND/NDA applications.
- Communication Coordination and Project Management Communicate with clients and internal departments to advance project progress. Ensure timely delivery of high-quality results.
REQUIREMENTS:
- At least 5 years of experience leading preclinical toxicology studies, with a track record of supporting regulatory submissions
- Certification or training in specialized areas, such as certified toxicologist (e.g., DABT – Diplomate of the American Board of Toxicology) or regulatory toxicology workshops.
- Proven people manage and team leadership experience
EDUCATION
(Indicate the mini. requirement & preferred discipline):
Doctoral Degree
OTHER SKILLS, ABILITIES & EXPERIENCE:
Good English (Spoken/ Written) and Mandarin
ADDITIONAL POSITION SPECIFIC DUTIES
Act as technical support on business development.