Clinical Research Physician社

面议

市辖区博士及以上4年及以上

发布时间：2023-09-06

职位描述

Responsibilities:


? Support medical director in drafting clinical trial protocol and study report.


? Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF etc. and processes which reside in other line functions.


? Establish and maintain liaisons with investigators.


? Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team.


? Support regulatory filing where medical expertise is required.


? Support drug discovery when clinical experience is needed for the medical “translation”.


? Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.


? Prepare and conduct regular meetings with investigators.


? Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.


? Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.


? Compliance with GCP, SOP and regulatory requirements.


? Study planning, preparation, conduct and report in terms of timeline, quality and quantity


? ( recruitment target ).


? Other tasks as assigned.


Qualifications:


? Graduate from Clinical Medicine with bachelor degree or above.


? At least 3-5 year clinical practice / clinical development / clinical research experience. Therapeutic area experience esp. oncology or hematology. Working experience with international pharmaceutical company or CRO is preferable.


? GCP experience is preferred.


? Proficiency in English and good computer skill at office software.


? Excellent planning, organization and problem solving abilities.


? Good communication and interpersonal skills.


? Good project management skill.


? Self-motivation and good risk managem***********************

其他要求

招聘人数：1人
职能类别：临床研究经理CRM

公司介绍

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品***理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。