Successful Clinical stage biopharmaceutical company with the scientific vision of revolutionizing the cancer treatment in various indications including solid tumors. Company specializing in the CAR-T area. Both Phase III and II clinical development programs successfully underway. The company has built up a robust operational and supply chain capabilities to successfully delivery autologous T cell therapy treatments to a large patient pool across 5 countries.
As Clinical lead, he/she will be responsible for scientific and clinical oversight of clinical trial in oncology/Hematology-oncology area.
- Main Point of Contact with study investigators and DMC (Data Monitoring Committee) for protocol-related clinical and scientific discussion, and scientific engagement.
- Work closely with study team to provide medical and scientific input, and to address protocol-related scientific and clinical questions and study-related issues, including feasibility assessment, patient recruitment, etc.
- Contribute to regulatory activities such as IND, NDA submission, and data cleaning activity.
- Key role in analysing the data, preparing clinical study report (CSR) and presenting to IDMC.
- Development of clinical documents such as protocol/amendment update, IB update, annual study report, etc.
- Clinical interface for other functions for successful delivery of study.
- MD required. (Medical Oncologist, or industry trained in oncology and/or immune-oncology or cell therapy)
- Experience in Pharma industry for 8 – 10 years.
- Experience in clinical trial or medical affairs in Oncology area for more than 5 years
- Knowledgeable in science of oncology and able to analyze the data.
- Candidate must possess highly effective communication skills, both written and verbal.
- Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support and contribute to a robust overall clinical development strategy.
- The candidate should be detail-oriented, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small global company environment.
up to $300K+ plus 25% Annual Bonus + Long Term Incentives
No, not at this time.
RF - 1056