1、与CRO制定临床计划和资源、以实现药品开发在监管方面的目标；
2、协调和管理监管策略的临床方面以及与卫生部门联络；
3、监督临床试验数据的分析和解释以及临床试验结果的报告；
4、协调与研究人员、合作团体和其他临床医生的沟通；
5、提供临床支持，并与管理团队的其他成员合作，制定和沟通整体企业战略；
6、审查与药品开发监管问题相关的事件；
7、负责招聘、留住和发展临床运营管理人员，以满足组织需求。

职位要求：
1、医学博士，有抗体药物、呼吸系统或肿瘤学方面的临床经验优先,做过呼吸类急自免类疾病临床相关；
2、至少10年临床实践经验，治疗患者和制药和/或生物技术行业经验，有呼吸系统药物经验者优先；
3、多年负责临床团队的管理经验，包括临床/医疗事务和临床运营；
4、了解美国食品药品监督管理局的相关法规和指南，以及欧盟-中国和其他卫生***的法规和指南；与美国食品药品监督管理局人员联络的经验及与其他卫生部门联络的基本经验优先；
5、英语读、写、说流利，具有出色的沟通能力，能够阐明公司的临床和监管战略以及进展；
6、出色的领导能力和人际交往能力：应具备有效的团队合作能力，能够在公司内外树立信誉和信心，和公司共同进步。



Responsibilities:
1. Developing clinical plans and resources with CROs to achieve regulatory goals for drug development;
2. Coordinating and managing the clinical aspects of regulatory strategies and liaising with health authorities;
3. Overseeing the analysis and interpretation of clinical trial data and the reporting of clinical trial results;
4. Coordinating communication with investigators, collaborating groups and other clinicians;
5. Providing clinical support and working with other members of the management team to develop and communicate overall corporate strategy;
6. Reviewing events related to drug development regulatory issues;
7.Responsible for recruiting, retaining and developing clinical operations management staff to meet organizational needs.
Position Requirements：
1.Ph.D. with clinical experience in antibody drugs, respiratory system or oncology preferred, having done clinical relevance in respiratory acute autologous diseases;
2. At least 10 years of experience in clinical practice, treating patients and experience in the pharmaceutical and/or biotechnology industry, with experience in respiratory drugs preferred;
3. 10+ years of management experience in ｃｈａｒge of clinical teams, including clinical/medical affairs and clinical operations;
4. Knowledge of relevant FDA regulations and guiｄｅｌines, as well as those of EU-China and other health authorities; experience in liaison with FDA personnel and basic experience in liaison with other health authorities preferred;
5.Fluent in English reading, writing and speaking, with excellent communication skills to articulate the company’s clinical and regulatory strategies and progress;
6. Excellent leadership and interpersonal skills.