Essential Functions
- To serve as local/regional development lead for phase I-III clinical development of pipeline compounds with oncology focus
- Contribute to clinical development plans for the product candidate as the clinical/medical expert
- Participate in all stages of the clinical trial development process including but not limited to feasibility assessments; protocol design; CRF design; investigational site selection; generation of clinical study reports, etc.
- Acts as Medical Monitor/Advisor for assigned trials or programs
- Provide medical support to the clinical project teams
- Provide clinical inputs to all study documents, clinical study reports, regulatory documents, publications, and etc. Provide clinical support to interacting with health authorities
- To represent Medical Sciences internally and externally, contributing local/regional medical insight into experimental design and data analysis
- Facilitate collaborations with external clinical investigators and researchers
- Work closely and collaboratively with a cross-functional group of experts in operations, regulatory affairs, statistics, data management, manufacturing, and business development
- Contribute to the assessment of business development opportunities
Qualifications
- Master of Medicine background
- Minimum 1 years of clinical research experience in academia and/or biopharmaceutical industry (biotech, pharmaceutical or CRO company)
- Demonstrate in-depth knowledge in Oncology TA
- Previous experience in early and/or late-stage oncology clinical trials and regulatory filings
- Experience in writing and editing scientific research reports
- Thorough understanding of GCP and familiarity with ICH guidance
- Excellent written in English
Please send resumes and career related inquires to hr@adagene.com
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