senior principal scientist，toxicology.

4、Interpret preclinical data from mouse and NHP models and provide risk assessments and development recommendations.
5、Provide sponsor oversight for toxicology studies, including study planning, CRO management, protocol and report review, study monitoring, data interpretation, and issue resolution.
6、Partner closely with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams to advance development programs.
7、Contribute to safety risk assessments related to target biology, exaggerated pharmacology, immunogenicity, biodistribution, insertional mutagenesis, and long-term safety.
8、Support preparation of regulatory documents and submissions, including China IIT, IND applications, investigator brochures, global regulatory filings, and responses to health authority questions.
9、Interpret complex nonclinical datasets and communicate key findings and recommendations clearly to internal stakeholders.
10、Provide technical leadership for toxicology strategy, project initiation, and nonclinical development planning.
11、Mentor junior scientists and contribute to the growth of toxicology capabilities within the organization.
12、Support in vivo pharmacology activities, when needed, through integrated assessment of efficacy, disposition, and safety findings.

 

Qualifications:
1、Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline.
2、Minimum of 8 years of experience in nonclinical toxicology or a related field within biotechnology or pharmaceutical R&D, with working knowledge of pharmacology principles.
3、Experience supporting cell therapy, gene therapy, biologics, or other advanced therapeutic platforms preferred.
4、Working knowledge of GLP toxicology studies, nonclinical pharmacology studies, CRO management, and regulatory expectations for nonclinical development.
5、Experience contributing to IND-enabling packages and global regulatory submissions is highly desirable.
6、Understanding of NMPA, FDA, EMA, and ICH regulations pertaining toxicology and cell and gene therapy development.
7、Experience evaluating immune-mediated toxicities, biodistribution, pharmacokinetics, insertional mutagenesis, and other safety considerations associated with advanced therapeutic platforms.
8、Scientific writing, communication, and presentation skills.
9、Demonstrated leadership, mentoring, and project management experience.
10、Ability to work independently while thriving in a collaborative, matrixed team environment.