Sr Medical Director / Medical VP
This is a first-in-classbiopharma company under pre-IPO stage
They are mainly foucs on Oncology related pipeline for global trial
About Our Client
This is a clinical stage biotech company with innovative antibody discovery and engineering technologies, they are development the immune-oncology antibodies against novel epitopes that give unique product profiles that potential to succeed where other groups have failed.
- Focus on design and implement of clinical development strategy and plan
- Take the lead to write and edit medical writing deliverable (clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data)
- Driving all phases of clinical research for submission to regulatory agencies and work with Regulatory(CDE,CFDA) to make sure they are in accordance with regulations, standards, and guidelines (ICH, GLPs, and GCPs guidelines, company SOPs).
- Collaborating the synopsis of clinical trials from US, reviewing full protocols and being responsible to update the clinical trial protocol and investigator brochure with local modification; Working with clinical operation team to monitor the implementation of the protocols, safety of the participants and integrity of the data during the studies; reviewing AE/SAE cases and reports;
- Effectively interact and communicate with KOLs/disease experts to discuss the design/implementation/update of clinical studies;
The Successful Applicant
- Ph.D. or MD degree in medicine related fields, overseas degree is preferred;
- Over 8-10 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 early clinical development program, familiar with domestic and US laws and regulations
What's on Offer
This is an innovative first-in-class bio-technology company, provide competitive compensation package and fast growing career path.