·Responsible for development of clinical protocols to support the company’s product drug candidates, strategy, data collection and management and final reports development in compliance with appropriate standard operating procedures, regulatory and good clinical practice standards.

·Responsible for clinical trial execution including, data analysis and reporting to prepare documentation required for regulatory and legislative drug approvals.

·Ensure adherence to industry standards of Good Clinical Practice.

·Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.

·Engage thought leaders, investigators, cooperative groups and other experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results. 

·Manage the preparation and/or review of data listings, summary tables, study results, study reports, and regulatory documents, IND annual reports, IND safety reports, investigator brochures, and clinical development plans.

·Coordinate the collection and analysis of clinical data, develop manuscripts for publication in peer-reviewed journals and prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert clinical advisory meetings.

·An MD with experience in Oncology, minimum of 3 years of relevant experience in drug development in pharmaceutical or biotechnology company.

·A proven success record in oncology clinical research studies and trial design as well as the successful submission of IND’s. 

·Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.

·Strong scientific background in oncology.

聯(lián)系人：Stephen Yu

郵箱：stephen.yu@isaac-kenneth.com