InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing innovative drugs for the treatment of cancers and autoimmune disease, with unmet medical needs worldwide. InnoCare has built up a fully integrated platform in terms of research and development, clinical development, manufacturing and commercialization. To date, the Company has developed a robust product pipeline comprising three approved drugs (orelabrutinib, tafasitamab and zurletrectinib), and more than ten innovative drug candidates in clinical development, and multiple programs in preclinical stages. InnoCare has successfully got listed on both Hong Kong Stock Exchange and the STAR Board of Shanghai Stoch Exchange. Our world-class team exhibits remarkable synergy and efficient execution, with entrepreneurial spirit, which has made outstanding achievements in innovation, commercialization and globalization. If you would like to join us, we will develop innovative drugs for the benefit of patients worldwide. Website link: https://www.innocarepharma.com/en. LinkedIn: InnoCare Pharma. Key Responsibilties Designing and implementing phase I-II-III clinical trials in the field of Hema-oncology or autoimmune, based on ICH-GCP and relevant clinical research guidelines. Responsible for supervising clinical trials, ensuring that protocols, standard operating procedures SOP’s, good manufacturing practices (GCP) and regulatory requirements are followed. Building and maintain relationship with study investigators through regular communications and in-person visits. Collaborating with internal stakeholders and external partners in ensuring progress and delivery of clinical trials under defined timelines and with quality. 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. Medical development responsibilities, including medical monitoring and training during clinical trials; data integrity; data interpretation and analysis; participation in safety committees; communicating with regulatory authorities on medical related topics; and writing medical research documents for registration or publication.
Requirements:
Doctor’s degree in Medicine (MD) required. Minimum of 3 years’ direct experience of clinical trials in the field of autoimmune and/or Hema-oncology fields; familiar with design and execution of phase I to III trials.
Relevant work experience in study design, trial implementation, medical monitoring, data integrity and interpretation in a CRO, pharmaceutical or clinical trial environment required.
Knowledge of both local and global regulatory requirements as well as local and global GCP requirements.
Strong written and verbal communication and inter-personal skills to work with internal stakeholders or external partners.
Flexibility with work assignments and working hours; night-time TC with corporate functions in China.
Travel up to 10% of time.
This Role is base in USA OR CHINA
