Director of Preclinical Development
at Shenzhen HighTide Biopharmaceutical, Ltd. in Shenzhen Guangdong China
Shenzhen HighTide Biopharmaceutical is a joint venture formed between a team of oversea returnees and Shenzhen Hepalink, the world largest heparin API supplier in 2011. The company is focused on the development of peptide therapeutics for unmet medical needs, such as diabetes, diabetic complications, and cancers.
The candidate will lead the preclinical development of company’s lead compounds. In particular, the candidate will be responsible for the development and execution of all parts of the IND enabling studies that satisfy both CFDA and FDA requirement.
Duties and responsibilities
- Oversea the overall design and implementation of the preclinical IND enabling studies of the company’s lead compounds, targeting metabolic diseases in compliance with CFDA/FDA regulations.
- Provide direct supervision to the company preclinical team.
- Supervise the technical and scientific performance of studies conducted at different CROs, in compliance with CFDA/FDA regulations, interpret, evaluate and document the obtained data.
- Monitor plans, track progress of project teams and ensure adherence to plan and strategy for project activities through IND-enabling studies.
- Collaborate with external investigators, clinical physicians, and opinion leaders.
- Be responsible to communicate with CFDA/FDA regulatory authorities during the IND process.
- Communicates frequently on all aspects of the project with the company CEO.
- In-depth knowledge of the drug development process with CFDA/FDA. Proven track records in IND filing with both authorities will be given preferred considerations.
- Knowledge and experience in the anti-diabetes therapeutic area are preferred.
- Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
- Excellent interpersonal and public speaking skills and strong ability to work in a start-up environment.
- Willingness to travel domestically and internationally.
HR Manager, Shenzhen HighTide Biopharmaceutical, Ltd.
Email: email@example.com; Phone: +86 755 2153 4843
We offer competitive salary and fringe benefits that are commensurate with qualifications.