|招聘岗位||Director of Medical Research|
1. Designing and implementing InnoCare’s phase I-II-III clinical trials for innovative drugs in the field of oncology and autoimmune diseases in China and abroad, based on cGCP, ICH-GCP and other relevant clinical research guidelines;
2. Providing medical monitoring and guidance during clinical trials, including data security audits; participation in safety committees; communicating with regulatory authorities, such as the CFDA, on medical research matters, and writing medical research documents for registration;
3. Medical support during the product development phase, including: medical knowledge of product design, medical analysis of competing products, translation and incorporation of medical data published in the scientific literature, providing medical rationale interpretation for Research and Development (R&D), etc.;
4. Providing medical strategic advice for InnoCare’s product portfolio, project development, and introduction or transfer of researching products (rights and interests);
5. Maintaining effective communication and cooperation with investigators, ethics committees, clinical research institutions, patient groups, and regulatory authorities at all levels in accordance with relevant policies and regulations.
1. PhD in Medicine or Life Science-related fields;
2. At least 5 years of experience in clinical trials in the field of oncology or autoimmune disease treatment with a successful implementation record from protocol design to full completion of Phase I-II-III clinical trials;
3. Comprehensive and in-depth understanding of the whole process of clinical trials of new drugs, including: design, implementation, and statistical/data management of clinical trials; Chinese and international norms and quality criteria; and requirements for pharmacovigilance;
4. Understanding and mastery of GCP and ICH guidelines, and familiarity with FDA and CFDA regulations.