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、確保藥品不良反應(yīng)檢測(cè)和報(bào)告的合規(guī)性，監(jiān)督開(kāi)展藥品安全風(fēng)險(xiǎn)識(shí)別、評(píng)估與控制，確保風(fēng)險(xiǎn)控制措施的有效執(zhí)行；

2、遵照法規(guī)和公司SOP要求對(duì)不良反應(yīng)/事件進(jìn)行上報(bào)；

3、負(fù)責(zé)藥品安全性信息溝通的管理，確保溝通及時(shí)有效，負(fù)責(zé)藥物警戒體系的建立、運(yùn)行和維護(hù)；

4、負(fù)責(zé)藥物警戒日常工作的監(jiān)督和決策，完成藥品安全委員會(huì)交辦的其它藥物警戒相關(guān)工作。

1、從事上市前藥物警戒工作8年及以上，碩士及以上學(xué)歷，醫(yī)學(xué)、藥學(xué)相關(guān)專(zhuān)業(yè)背景；

2、熟悉國(guó)內(nèi)外藥物警戒相關(guān)法律和技術(shù)指導(dǎo)原則，PVP優(yōu)先；

3、具備藥物警戒管理工作的知識(shí)與技能；

4、有較強(qiáng)的溝通能力和執(zhí)行能力；

5、英文讀寫(xiě)熟練；熟練使用辦公軟件。

1. 協(xié)助首席注冊(cè)官共同制定注冊(cè)策略，確定注冊(cè)關(guān)鍵點(diǎn)，把控審批風(fēng)險(xiǎn)；

2. 負(fù)責(zé)審核及撰寫(xiě)藥品注冊(cè)申報(bào)資料，確保申報(bào)品種的審評(píng)及審批進(jìn)程, 及時(shí)解決或反饋該過(guò)程中出現(xiàn)的問(wèn)題及提案；

3. 掌握項(xiàng)目整體進(jìn)度，定期組織對(duì)項(xiàng)目進(jìn)行階段性審核；負(fù)責(zé)對(duì)臨床全過(guò)程提供注冊(cè)法規(guī)指導(dǎo)及支持，指導(dǎo)公司項(xiàng)目合規(guī)開(kāi)展；

4. 及時(shí)捕捉、解讀并反饋FDA注冊(cè)相關(guān)政策及產(chǎn)品申報(bào)信息的更新，為公司決策提供建議并在公司內(nèi)部做好培訓(xùn)；

5. 與相關(guān)政府機(jī)構(gòu)建立良好關(guān)系，與監(jiān)管機(jī)構(gòu)積極溝通，促進(jìn)注冊(cè)項(xiàng)目順利進(jìn)行；

6. 建立和優(yōu)化注冊(cè)法規(guī)事務(wù)相關(guān)規(guī)章制度和工作流程。

1. 醫(yī)學(xué)、藥學(xué)、生物化學(xué)、藥事管理等相關(guān)專(zhuān)業(yè)碩士及以上學(xué)歷；

2. 10年以上藥品注冊(cè)工作經(jīng)驗(yàn)，其中有3年及以上生物新藥申報(bào)經(jīng)歷，有成功的IND& NDA項(xiàng)目申報(bào)經(jīng)驗(yàn)優(yōu)先；

3. 熟悉藥品注冊(cè)的相關(guān)法律法規(guī)及有關(guān)藥物研究指導(dǎo)原則，熟悉藥品注冊(cè)申報(bào)流程和各個(gè)環(huán)節(jié)、申報(bào)資料的撰寫(xiě)審核及與CFDA專(zhuān)家深度溝通的能力；

4. 較強(qiáng)的藥品注冊(cè)信息檢索和分析調(diào)研能力，能準(zhǔn)確理解FDA、EMA等國(guó)外相關(guān)網(wǎng)站和文獻(xiàn)，英文較強(qiáng)讀寫(xiě)能力，基本聽(tīng)說(shuō)能力；

5. 優(yōu)秀的溝通交流與書(shū)面表達(dá)能力，具有良好的項(xiàng)目運(yùn)作能力、分析判斷能力及解決問(wèn)題的經(jīng)驗(yàn)，思路清晰；

6. 具有高度的責(zé)任心、原則性強(qiáng)，為人正直、自律，工作嚴(yán)謹(jǐn)。