Professional：

1. Bachelor’s degree or above in clinical medicine, pharmacology, biology, or related fields.

2. At least 5 years of clinical research experience, including 3 years of project management experience in anti-tumor new drug clinical research.

3. Mastery of GCP and SFDA regulations related to new drug clinical trials; familiarity with trends in domestic drug clinical development.

4. Excellent project management, expert communication, and coordination skills.

Work Location: Suzhou Industrial Park

Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Responsible for the implementation of the company’s new drug clinical trials, monitoring the clinical trial process to ensure compliance with GCP requirements.

2. Communicate and coordinate with clinical researchers, CROs, and other partners to advance clinical project timelines.

3. Participate in the development of clinical study plans and protocols, and evaluate and select cooperative sites.

4. Participate in drafting clinical-related documents for project submission, and Assist registrants with new drug application procedures.

5. Support communication and provide input on clinical information for drug evaluation and review.

Professional：

1. Master’s degree or above in clinical medicine, pharmacy, biology, or related fields; background of clinical medicine preferred.

2. Familiar with regulations governing clinical research and the entire GCP clinical trial process, with at least 10 years of clinical research management experience.

Work Location: Suzhou Industrial Park

Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Oversee the entire process of clinical drug trials, including protocol development, selection of clinical trial sites, effective project implementation, and quality control.

2. Communicate and liaise with CDE review experts, clinical experts, CROs, CRCs, and other clinical research resources to ensure smooth conduct of clinical studies.

3. Responsible for departmental process and system establishment, as well as staff training and performance evaluation.

Professional：

1. Master’s degree or above in clinical medicine, pharmacy, or related fields.

2. At least 8 years of clinical research management experience in the pharmaceutical industry.

3. Proficient in GCP regulations, familiar with clinical trial requirements and relevant policies/regulations.

4. Strong sense of responsibility, innovation, teamwork, and adaptability.

Work Location: Suzhou Industrial Park

Submission Email: david.zhang@teligene.com ; ying.zhang@teligene.com ; ruolan.kong@teligene.com

Job description:

1. Develop clinical research strategies and efficiently manage the clinical  team, external collaborations, and CROs.

2. Develop clinical study protocols, communicate with corresponding clinical trial centers, and provide training.

3. Supervise the execution of clinical protocols.

4. Evaluate, select, and establish collaborations with clinical trial sites and centers, and sign cooperation agreements.

5. Collaborate with clinical trial centers to accelerate patient recruitment.

6. Track amendments and interpretations of policies and regulations related to new drug clinical trials.

7. Ensure compliance of clinical research with regulatory and policy requirements.

8. Control clinical trial budget and timeline.

9. Submit clinical trial progress reports to Senior management.

10. Provide solutions and responses to issues arising during clinical trials.

11. Assist in establishing and strictly adhering to the company’s clinical  SOPs.

12. Support the evaluation and recommendations for clinical application of new drugs introduced and developed.

13. Assist the Regulatory Affairs department in submitting NDA s and obtaining new drug approval.