- Cell-therapy for Solid Tumours
- In-house developed TIL technology
About Our Client
Our client is early stage China biotech company focusing on developing TIL immunotherapies targeting solid tumours. Currently at IIT trial in stage in China , they are accelerating towards first IND submission in China and looking to initiate their global submission in the nearest future.
At the moment their assets are build around Solid tumours (ovarian cancer and melanoma) with pre-clinical data signifying possible expansion to other indications and new generations therapies.
- As Head of Clinical Operations you will support all on going Clinical programs from IIT stage all the way to future Phase III trials in China and Global
- You will report to CEO of the company directly and be part of key decision making processes related to Clinical milestones
- You will work closely with other departments including Pre-Clinical, CMC, Regulatory etc.
- Immediate focus will be on supporting the progress with IIT trials in China. Mid-term focus would be on supporting China IND and Phase I and preparing for Global Clinical submissions
The Successful Applicant
- Advanced degree in Medical or similar field and at least 8+ years of experience in the industry
- Experience in clinical pharmacology, data management, pharmacovigilance, medical science will be a plus
- Excellent knowledge of CFDA and FDA regulations and expectations, GCPs, ICH guidelines for all phases of Clinical Development
- Solid knowledge of FIH and early stage trials for biologic drugs for Oncology field will be preferred
- Strong team leadership ability to attract and develop Clinical team
What's on Offer
You will be offered competitive salary and bonus package along with the opportunity to develop within the team of professionals.