1. Responsible for the conduct of assigned clinical studies, including clinical study plan, CRO activities, project timelines and budget, management of Consultants/Advisors and any other related activities.

2. Ensure the clinical studies are carried out in accordance with regulatory requirements, ICH and GCP principals.

3. Participate in selection of study vendors and keep good working relationship with the selected vendors to ensure the status of clinical studies is up-to-date, issues are attended and resolved timely, and the clinical studies are progressing according to plan.

4. Identify and provide solutions to clinical issues and risks. Any unresolved issues are escalated appropriately.

5. Coordinate internal and external clinical development activities of team members involved in the design and conducted of clinical trials.

6. Ensure any safety issues AEs/SAEs are properly managed and reported according to regulatory requirements.

7. Ensure all clinical study related SOPs are in place and updated according to GCP requirements.

8. Contributes to relevant study documentation including protocols, data review, statistical analysis plan, clinical study reports and operational plans.

9. Oversees submission of trial-related and essential documents to Trial Master File.

10. Provide training to junior staff as required.

1. BS or Master’s degree in nursing, life science, or medical/pharmacy related fields.

2. 5~8 years of relevant clinical research experience in a pharmaceutical company or CRO.

3. Thorough knowledge of ICH, and GCP guidelines, clinical study process and procedures, and reporting of AEs/SAEs.

4. Proven track record showing clear proficiency in clinical project management skills and broad understanding of clinical operations, and CRO/vendors management skills.

5. Good communication skills, both oral and writing. Fluent in English.

6. Good inter-personal skills. Demonstrated ability to successfully participate as a member of a project team.

7. Demonstrated ability in managing multiple competing priorities and problem solving.

1. According to Doma’s corporate and portfolio strategy, explore collaboration opportunities with the partners.

2. Support Due Diligence，coordinate with PM and R&D head to ensure project quality and timeline, negotiate contract;

3. Brand Doma via various channels and seek potential partnership;

4. Keep up with the latest market and industry development landscape, Work closely with leaders and cross-functional management team members to design and execute the Doma’s business development strategy. 

1. Master degree or above in biology, other relevant fields, at least 3+ years’ Business Development industrial working experience in biotech and/or pharmaceutical companies;

2. Strong communication skills in English and ppt drafting，able to work independently and a strong team player;

3. Prefer consulting background, good at communication & impact on internal and external stakeholders;

4. Excellent presentation skill both written and oral;

5. Familiar with BD process and good at negotiation;

6. Self study and curious in new science;

7. Familiar with financial analysis.

1、Responsible for design of clinical studies and development of study protocols, IBs, clinical study report and other study documents to ensure compliance with regulatory requirements and GCP/ICH guidelines;

2、Be a medical monitor, manage medical and safety issues and queries derived from clinical studies;

3、Review safety data, evaluate, analyze, monitor the trend and report as appropriately;

4、Liaison with study investigators, especially investigators in China, discuss and resolve any issues which may occur during the clinical studies;

5、Provide training on study protocols, relevant diseases and medical guidelines;

6、Keep updated knowledge on the diseases related to company products and guidelines on the management of the diseases of WHO, international, and China.

1、Bachelor of Medical degree is required. Higher degree would be an advantage；

2、8 years of relevant clinical research experience in a pharmaceutical company or CRO；

3、Thorough knowledge of ICH, and GCP guidelines, clinical study process and procedures, and reporting of AEs/SAEs；

4、Good communication skills. Able to communicate in English fluently both in writing and orally；

5、Proven track record in clinical study design and writing study protocols and study documents；

6、Updated knowledge on oncology/immunology, and proven record as a medical monitor in clinical studies of biological product. Preferred working experience in biosimilar clinical studies；

7、Good inter-personal skills. Demonstrated ability in people management and negotiation skills；

8、Demonstrated ability in managing multiple competing priorities and problem solving. 

1、确保药品不良反应检测和报告的合规性，监督开展药品安全风险识别、评估与控制，确保风险控制措施的有效执行；

2、遵照法规和公司SOP要求对不良反应/事件进行上报；

3、负责药品安全性信息沟通的管理，确保沟通及时有效，负责药物警戒体系的建立、运行和维护；

4、负责药物警戒日常工作的监督和决策，完成药品安全委员会交办的其它药物警戒相关工作。

1、从事上市前药物警戒工作8年及以上，硕士及以上学历，医学、药学相关专业背景；

2、熟悉国内外药物警戒相关法律和技术指导原则，PVP优先；

3、具备药物警戒管理工作的知识与技能；

4、有较强的沟通能力和执行能力；

5、英文读写熟练；熟练使用办公软件。

1. 协助首席注册官共同制定注册策略，确定注册关键点，把控审批风险；

2. 负责审核及撰写药品注册申报资料，确保申报品种的审评及审批进程, 及时解决或反馈该过程中出现的问题及提案；

3. 掌握项目整体进度，定期组织对项目进行阶段性审核；负责对临床全过程提供注册法规指导及支持，指导公司项目合规开展；

4. 及时捕捉、解读并反馈FDA注册相关政策及产品申报信息的更新，为公司决策提供建议并在公司内部做好培训；

5. 与相关政府机构建立良好关系，与监管机构积极沟通，促进注册项目顺利进行；

6. 建立和优化注册法规事务相关规章制度和工作流程。

1. 医学、药学、生物化学、药事管理等相关专业硕士及以上学历；

2. 10年以上药品注册工作经验，其中有3年及以上生物新药申报经历，有成功的IND& NDA项目申报经验优先；

3. 熟悉药品注册的相关法律法规及有关药物研究指导原则，熟悉药品注册申报流程和各个环节、申报资料的撰写审核及与CFDA专家深度沟通的能力；

4. 较强的药品注册信息检索和分析调研能力，能准确理解FDA、EMA等国外相关网站和文献，英文较强读写能力，基本听说能力；

5. 优秀的沟通交流与书面表达能力，具有良好的项目运作能力、分析判断能力及解决问题的经验，思路清晰；

6. 具有高度的责任心、原则性强，为人正直、自律，工作严谨。