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20200902 本周职位精选:CMC、R&D、临床 | 招聘
招聘·2020-09-01
招聘
德琪医药、来凯医药

免费发布招聘信息,联系邮箱:recruit@PharmaDJ.com


公司名称:德琪医药

临床研究医师 Study Physician

职位类别:Clinical Development

直接上级:Director

直接下级:无

薪资范围:面议

学历要求:M.D. degree 

工作地点:上海

职位描述:

主要职责和任务:

1.Manage global or regional studies and involve in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials.

2.Provide expert scientific and clinical input to Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments.

3.As a trial level physician and medical monitor for clinical studies.

资格要求:

1.M.D. degree & 2Y+ industry drug development experience.

2.Experience specific to oncology preferred.

3.Fluent in English, both verbal and written.

医学撰写 Medical Writer

职位类别:Clinical Development

直接上级:Director

直接下级:无

薪资范围:面议

学历要求:Medical related degree 

工作地点:上海

职位描述:

主要职责和任务:

1.Research, write, and edit clinical documents, including clinical study protocols, clinical study reports, IB, ICF, RMP, clinical plan outlines, and scientific manuscripts.

2.Review statistical analysis plans and mock statistical output to assist in determining appropriateness of content/format for clinical writing.

3.Provide medical editing review of draft and final documents.

4.Perform literature searching and reviews as necessary.

资格要求:

1.Medical related degree & 2Y+ medical writing experience.

2.Experience in clinical study design and protocol development and CSR/writing.

3.Fluent in English, both verbal and written.

医学顾问 Medical Affairs Advisor

职位类别:Medical Affairs

直接上级:Department Head

直接下级:无

薪资范围:面议

学历要求:Master degree or above in Clinical Medicine/Biology

工作地点:上海/北京

职位描述:

主要职责和任务:

1.Establish Medical Strategy for pre-launch brand and pipeline products.

2.Conduct productive engagement with key national stakeholders.

3.Design and compose study protocol post launch.

4.Design and implement medical activities.

5.Provide strategic advice and support for corporate business development.

资格要求:

1.Master degree or above in Clinical Medicine/Biology.

2.3Y+ medical experience on Hematology/Solid Tumor area.

3.Experience of clinical trial design and implementation.

Scientist

职位类别:Clinical

直接上级:主管

直接下级:无

薪资范围:10000-12000元/月

学历要求:本科以上

工作地点:上海市东明路1800号7-205室

职位描述:

主要职责和任务:

1. 根据临床试验项目需求,查阅医学信息和参考文献;

2. 参与临床试验方案讨论,汇总研究团队意见和建议;

3. 起草、撰写或审核、修改临床试验方案、知情同意书、总结报告;

4. 撰写、翻译其他临床试验相关的医学专业文件;

5. 无需出差。

资格要求:

1. 临床医学专业本科,药理专业本科及以上学历;有肿瘤专科经验的优先考虑;

2. 具有检索、翻译、分析中英文医学文献,书写中英文医学报告的能力;

3. 了解临床试验流程,有相关经验的优先考虑;

4. 能够独立思考、解决问题,善于沟通。


简历投递邮箱:molly.dai@antengene.com


公司名称:来凯医药

Director of Biologics CMC

职位类别:CMC

直接上级:Head of CMC

直接下级:无

薪资范围:面议

学历要求:Ph.D. or Master  

工作地点:上海浦东张江

职位描述:

As antibody or protein manufacture process development lead for Laekna therapeutics, this role will be responsible for all biologics manufacture development activities to support Laekna’s biologics pipeline at different stages ranging from preclinical, clinical, and commercialization. He/she will oversee all process development related activities through active coordination and communication internally and externally to meet project timeline. He/she will serve as antibody expert and provide technical leadership to promote Laekna’s scientific competitiveness.

主要职责和任务:

1.Responsible for process development of biologics product including but not limited to cell line development, cell culture and protein purification process development, and formulation development to enable Laekna’s product for clinical studies and commercialization.

2.Responsible for planning and execution of GMP manufacturing of antibody product to support clinical studies and commercialization.

3.Responsible for IND/BLA dossier writing and relevant regulatory documents to support Laekna’s product registration with FDA/EMA/NMPA and other regulatory agencies.

4.Serve as antibody CMC expert and provide technical leadership to both internal and external collaborators to ensure rigid science in Laekna’s product development and meet project timeline defined by upper management.

5.Oversee all antibody CMC related functions through internal management and external collaboration to ensure project execution.

6.Enhance awareness of antibody CMC functions and provide technical training internally to better align internal resources.

资格要求:

1.Master with over 10 years or PhD with over 8 years working experience in big pharm or biotech companies directly involving antibody process development for various large molecule product including mAb, Bis-mAb, fusion protein, ScFv, Fab, and single variable VH and VL domains, etc.

2.Familiar with regulatory CMC requirements for FDA/EMA/NMPA and have rich experiences in writing IND/BLA dossiers to different regulatory agencies for multiple products.

3.Strong leadership and excellent management skills to oversee multiple projects for fast progress and timely communication with upper management and relevant parties.

4.Self-driven initiative and strong willing to work in startup environment to learn, share, and grow.


简历投递邮箱:hr@laeknatp.com

文章关键字:德琪医药,来凯医药
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