Job Responsibilities:
1. Formulate/review pharmacology, pharmacokinetics and toxicology experimental research protocols for innovative ADC, small molecule or antibody drugs and organize their implementation; 
2. Contact, coordination, follow-up and supervision of outsourcing tests; 
3. Write/review the clinical pharmacology part of the trial summary report/investigator's manual and IND/NDA/BLA application materials as needed; 
4. Provide relevant technical support for project screening and other research projects, including clinical projects;
5. Combined with quantitative pharmacology tools, interpret PK/PD/AE and other data, communicate with external experts when necessary, and provide clinical pharmacology support for clinical trial protocol design and clinical development decisions
6. Predict clinical practice according to preclinical information (pharmacokinetics, pharmacodynamics and toxicology, etc.), assist/efficiently design reasonable phase I trials, and be responsible for communicating with clinical pharmacology experts to ensure the scientificity and implementability of the design of relevant content of the program.

 

Qualifications:
1. Educational requirements: doctoral degree or above, overseas background or relevant work experience in TOP biopharmaceutical companies is preferred;
2. Professional requirements: biology, DMPK, toxicology, pharmacology and related majors;
3. Work experience:
(1) More than 5 years of experience in antibody pharmacological analysis and development, and experience in completing IND/BLA/NDA application is preferred;
(2) Familiar with the efficacy, toxicology or pharmacokinetics of antibody drugs, able to independently design experimental protocols and review experimental reports,
Experience in pharmacological development of ADC drugs is preferred;
(3) Familiar with PK/PD analysis and population pharmacokinetic analysis;
(4) Familiar with the pharmacological aspects of biotechnological drugs, registration and declaration, relevant laws and regulations and relevant research guidelines.
4. Competency requirements:
(1) Have the ability of management and coordination within and between departments, as well as project management experience in the simultaneous promotion of multiple projects;
(2) Self-driven, with a high sense of responsibility and entrepreneurial spirit;
(3) Have good communication, organization and coordination skills and excellent team management skills;
5. Language requirements: excellent reading, writing and communication skills in Chinese and English.

Pharmacology Director