Website HighTide Therapeutics
Founded in Shenzhen, China, HighTide Therapeutics is a global clinical-stage biopharmaceutical company focused on discovering and developing novel drugs to treat chronic liver diseases, gastrointestinal diseases, and metabolic disorders with high unmet needs. The company integrates expertise in disease biology, medicinal chemistry, clinical development, and regulatory affairs to advance its growing pipeline of drugs. The company’s lead drug candidate, HTD1801, is a first-in-class new molecular entity, currently in Phase II trials for the treatment of primary sclerosing cholangitis (PSC), and nonalcoholic steatohepatitis (NASH). The FDA has granted HTD1801 Fast Track Designation in both diseases.
Director, Clinical Medicine
JOB TYPE: Full-time
Location: Shenzhen/ Shanghai, China
- Manage ongoing clinical study
- Provide clinical/scientific inputs during the development and execution of clinical trials
- Responsible for patient enrollment, manage and monitor drug safety
- Conduct regular communications with regulatory agencies
- Prepare the required regulatory materials for clinical trials, including study synopsis, protocols, investigator brochure, study safety report, and study report. Review any relevant regulatory documents, including CRF, ICF, DSUR, SUSAR and CIOM.
- PhD. or MD degree in medicine related fields, overseas degree is preferred;
- At least 8 years experience in medical institutions, pharmaceutical companies, or CRO clinical related work experience; clinical science experience in the field of oncology or immunology is preferred;
- Ability to independently formulate clinical development strategies and writing medical protocols
- Rich experience in the early clinical development programs, familiar with domestic and US laws and regulations
Contact: Lin Zhang