China Development Center seeks individuals to support and conduct clinical research in China. One of the most critical missions of clinical research in China is to shorten the gap in drug lag so that effective treatment options become available to Chinese patients. This individual will be assigned program(s) to support the development of the new asset, engaging key opinion leaders, developing study protocol, running regular medical monitoring to ensure the data quality, drafting study reports, and preparing a dossier for regulatory submission.
As a Clinical Scientist, this individual will play an essential role in clinical development in China. This individual will be responsible and accountable for clinical development in China, working closely with the headquarters and the China project development team. This individual is expected to be responsible for different programs across therapeutic franchises to support clinical trial programs in hematology.
- This individual will be the clinical scientist who will abstract high-level relevant clinical and preclinical data and effectively use these data to support China's registration. The clinical scientist will actively support the China development team in addressing issues/questions raised during the development stage. This individual should have excellent communication skills and demonstrated language skills in both written and verbal English and Chinese.
- Whenever Clinical Research designs a clinical study, the clinical scientist (clinical monitor) is expected to collaborate with biostatisticians, regulatory affairs, operations, and other relevant disciplines to construct a high-quality clinical study protocol. We value efficiency, feasibility, most desirable labels, and cost-effectiveness, necessitating careful collaboration with operational experts. The clinical monitor will support the interpretation and preparation of clinical study reports, regulatory dossiers, and regulatory responses, as well as the review of product labels. The clinical scientist will also prepare and review the manuscript for publication. This individual will work with the study team to ensure safety/efficacy information is adequately captured and review serious adverse events. The clinical scientist will review the monitoring reports/data listings.
- The clinical scientist will provide scientific inputs to CSA submission, EC review, HGRAC review, and investigator meeting during the study initiation phase, run regular medical monitoring and review protocol deviation, provide scientific training when appropriate, and answer protocol-related questions during the study implementation phase.
- To develop the best, most suitable clinical plan and protocol, the clinical scientist is expected to engage scientific leaders (KOLs) and internal key stakeholders such as medical affairs, marketing, regulatory affairs, etc. The clinical scientist will also be involved in introducing new compounds in development to China KOLs and seeking feedback for our clinical development plan as needed.
Requirements
- A M.D. /PhD in clinical medicine with postgraduate training in Hematology.
- Deep understanding of China's regulatory environment and clinical development procedure.
- Previous experience in clinical research development, including medical monitoring and protocol/CSR writing, is highly desirable.
- The candidate who is ideally suited for this position will be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful.
- The candidate should have strong team spirit, excellent written and oral communication skills, and scientific logistic thinking.
- Strong work prioritization capability and delivering results with multiple parallel tasks.
- Excellent language skills in both English and Chinese (fluent in verbal and written).
The position may require the flexibility to work outside primary medical specialization.