Toxicology Manager

Location:

Guangzhou, Guangdong, China

岗位职责/Position responsibilities:

• 推进新药项目的非临床毒理研究，包括参与制定研究策略，确定CRO，推进相关合同，跟进实验进度。Move ahad the nonclinical tox studies for new drug projects, including designing study strategy, CRO selection, contract management, following up the study.

• 参与项目非临床筛选研究，包括实验设计讨论和推进，结果汇报。Participate in the process of nonclinical screening projects, including study design and conducting, results reporting.

• 撰写内部开展的相关研究方案或报告，以及审阅CRO完成的方案和报告。Write protocols and reports of studies carried out internally, review protocols and reports completed by CRO.

• 参与项目资料调研，研究数据总结及结果汇报。Participate in the process of literature research, summarize study data and report study results.

• IND/NDA/BLA 申报相关资料的撰写,包括申报中国和国外的项目。Draft the IND/NDA/BLA submission documents，including NMPA and global applications.

• 根据需要协助完成非临床向临床的转化。Assist in the science translation from nonclinical study to clinic.

任职资格/Qualifications:

• 药学/生物学相关专业，硕士以上学历。Major in pharmacy/biology, master’s degree or above.

• 有在新药研发企业或CRO工作3年以上的新药非临床研究经验，其中有2年新药毒理研究相关经验，熟悉GLP者优先。More than 3 years of working experience of nonclinical study in pharm or CRO, with at least 2 years of experience in new drug toxicology study；those who are familiar with GLP is preferred .

• 熟悉国内外非临床及临床药代动力学、安全性评价相关的指导原则。Familiar with guidelines for nonclinical safety evaluation.

• 有IND/BLA申报经验者优先。IND/BLA filing experience is preferred.

• 英语六级或以上，较好的英语阅读，撰写和表达能力。CET-6 or above. With Good skills of English reading, writing and expression.

• 有较强的沟通能力，可胜任与不同职能部门同事及合作方的高效沟通。Strong communication skills, able to efficiently communicate with colleagues from different departments and external partners.

• 有较强的抗压能力，全力配合项目的全力推进。Strong ability to work under pressure to ensure moving ahead projects smoothly.

• 有很强的责任心和团队合作精神，可以与来自国内外的同事通力合作。Strong sense of responsibility and teamwork spirit, able to cooperate closely with colleagues across the globe.

About Angitia:

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.

Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.