上海招聘

Role Title职位名称: Respiratory Disease Clinical Research Physician, GSK China R&D
Report to上司职位: Associate Director, Therapeutically Area Leader - respiratory disease, Medicines Development, GSK China R&D
Location驻地: Shanghai/Beijing

Role Purpose职位目的:
Provide medical support to clinical trials and new product registration in respiratory disease area in China

Key Accountabilities/Responsibilities主要工作职责:
1.Clinical trial support :
1.1 Ensure all clinical studies operate to the highest level of ethical and safety standards and in compliance with GCP, SOPs and regulatory requirements
1.2 Develop appropriate protocol synopsis and protocols to meet local registration need, and to support research proposals. Actively assist IND submission and the panel meeting preparation.
1.3 Leading the feasibilities at program, protocol and site level for global/regional studies, and provide timely and quality feedback.
1.4 Translate final protocols and amendments for global/regional studies.
1.5 Assist with study operation team in coordinating Principal Investigator and leading site selection
1.6 Prepare and deliver presentations for product and protocol introduction at investigator meetings and trainings to study team
1.7 Act as protocol medical Monitor to approve protocol deviations, analyze AEs/SAEs, and answer clinical and product queries from investigators
1.8 Provide valuable inputs in SAP (statistical analysis plan) finalization and efforts in achieving Database clean
1.9 Prepare and finalize local clinical study report, CTR and study results publication, and assist NDA submission
2.Maintain high level of clinical understanding of GSK products and assigned disease area, provide knowledge training to study team as needed
3.Establish and Maintain an effective network of relationships with key opinion leaders in assigned disease area

Qualifications/Requirements: (Education / Experience / Competencies)
申请资格 / 职位要求：(教育背景 / 工作经验 / 知识与技能)
Knowledge & Experience
·Medical education background.
·Knowledge of clinical development process, and regulatory requirements
·At least 3 years experience in medical practice and 3-4 years experience in industry medical team, including the clinical study management, protocol/study report writing.etc
Skills
·Good command of English (written and spoken);
·Knowledge of PC (WORD, EXCEL, POWERPOINT);
·Interpersonal communication skill;
·Team player
·Presentation skill
·Project Management
·Leadership and people management

葛兰素史克是最早在中国大规模投资研发领域的国际制药公司之一，通过与中国政府、学术机构和医疗专家保持密切的合作，致力于提高中国人民的健康水平。在进入中国的20多年间，我们在国内的药物研发和临床研究方面已投入了10亿元人民币。我们的目标是使中国成为葛兰素史克全球研发体系中一个重要的战略中心。