CBMG Job Openings in May 2016
CBMG Job Openings
岗位名称Position: 医学报告撰写专员Medical Writer
工作地点Location: Shanghai
汇报条线Direct report: COO
岗位职责Job Description:
Writing, summarizing, editing, and reviewing documents, or sections of documents
Ensuring architecture and content that concisely and effectively transmit strategic information
Coordinating the activities within Clinical Documentation, and other related functions, or external collaborators, to ensure timely completion of deliverables
Defining and proposing best timelines for Clinical Documentation deliverables, in collaboration with authoring or submission teams
Defining and requesting quality control for Clinical Documentation deliverables
Business writings for investors or other related audience assigned by CEO
任职资格Requirements:
Verbal and written fluent command of English
demonstrable ability to communicate clinical data succinctly, clearly and accurately in writing
demonstrable excellent interpersonal and team-working skills
Education:
Master or above, majoring in medicine, pharmacy, or life science related disciplines.
Publications in the international journals as the first author would be a plus
Contact Information
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
岗位名称Position: 国际注册经理/专员
工作地点Location: 上海
汇报条线Direct report: 注册事务部副总监
岗位职责Job Description:
1. 国际药品注册文件的组织翻译、编写、审核与提交归档；
2. 根据公司制定的注册策略和计划，对公司内部进行有效的指导和培训，推动项目按照计划实施；
3. 跟踪注册文件的评审，及时回复注册评审中的问题， 能够与官方进行有效的沟通；
4. 掌握和跟踪国内外注册法规的变化， 支持新产品的调研与开发；
任职资格Requirements:
1. 药学英语、生物学、医学、生物制药、国际药政及相关专业本科以上学历，2年以上美国FDA注册工作经验或留学背景者优先；
2. 有专业英语写作（汉译英）经验；
3. 了解药品生产过程，熟悉药品生产GMP；
4. 良好的沟通能力和组织管理能力 ；
5. 优秀的职业精神和团队合作精神。
Contact Information:
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
岗位名称Position: Medical Director
工作地点Location: Shanghai
汇报条线Direct report: SVP, Clinical Research and Development
岗位职责Job Description
· The Medical Director will be responsible for the overall medical affairs of CBMG in China, including protocol development, study implementation, as well as medical, clinical and safety oversight, such as medical promotion, pharmacovigilance, drug safety, pre-marketing research & development and key opinion leader management.
· This position will not directly supervise others, but will service lead roles on project teams and clinical study teams, such as providing clinical support to regulatory, process development, research, and manufacturing functions. This position reports to the SVP Clinical Research and Development Dept.
任职资格Requirements
· Experience designing, conducting Phase 1-3 clinical trials in oncology.
· Proven experience in leading project and clinical study teams in industry setting.
· Understanding of cellular immunology and typical assay systems for same
· Understanding of viral vector gene transfer technology (understanding of or experience with gene modified cellular therapeutics and safety monitoring for same, strongly preferred)
· Proven experience supervising and managing trial activities with CRO support
· Prior experience writing and submitting INDs to FDA; experience with pre-IND and EOP1 meetings preferred.
· Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
· Strong verbal and written skills
Contact Information:
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
岗位名称Position: Research Associate （CART R&D/ Stem Cell R&D）
岗位职责Job Description: Cell therapy R&D for immuno-oncology and degenerative diseases
任职资格Requirements:
The qualified candidates are expected to be or have
· Highly self-motivated and creative
· Master or Doctor’s degree in cell biology/Immunology/molecular cell biology or related fields
· Candidates with experience and training in molecular biology, immunology are preferred
· Experience on antibody library or phage library is A PLUS
· Good command of English and basic computer skills
· Strong sense of responsibility, collaboration and independence
· Patience, carefulness and consideration
· Strong interpersonal and communication skills
· Open-minded and competent to learn new ideas and techniques
· Candidates with independent SCI publications are preferred
Contact Information:
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
岗位名称Position: Scientists in Immuno-oncology Department
Number of People: 2
岗位职责Job Description:
· The incumbents will be part of a team responsible for CART and/or TCR development and the relevant immunology research work (ELISA, Flow Cytometry, Q-PCR etc.).
· Work with a team of passionate scientists to optimize the manufacturing conditions for CAR engineered T cells;
· Work closely with clinical pharmacogenomics and translational medicine teams to develop new CAR/TCRs in cancer indications
· Application of gene editing technology to adoptive cell therapy research
· Help with patent application and translational science studies for clinical trials
任职资格Requirements:
The qualified candidates are expected to be or have:
· Highly self-motivated and creative;
· MS or PhD degree in cell biology/Immunology/molecular cell biology or related fields;
· Candidates with extensive experience and training in molecular biology, immunology are preferred.
· Candidates with cell therapy experience are highly appreciated;
· Experience with antibody library or phage library construction, or gene editing is A PLUS;
· Be able to work effectively under team matrix and in collaborative environment;
· Strong interpersonal and communication skills; Candidates with strong SCI publications are preferred.
Contact Information:
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
岗位名称Position:
Scientists in Translational Science
岗位职责Job Description
We have a couple of openings within the translational science department. The competent candidates will be expected to work very closely and collaboratively with scientists from preclinical research, clinical development and TS pharmacogenomics within CBMG to support the clinical development of key assets. He/she will mainly work on cell therapy projects including CART and responsible for in house TS biomarker testing, the biomarker portion of clinical protocols, study procedure manuals, investigator brochures, and biomarker study reports.
任职资格Requirements
Basic qualifications:
• MS/Ph.D. in cancer biology, immunology, molecular oncology, molecular biology, cell biology, clinical pharmacology or a related field with 2-4 years postdoctoral experience; Medical training in hematology oncology and oncology are a plus.
• Scientific background in cancer biology and/or cancer genetics, as demonstrated by multiple publications in this area.
• Expertise/understanding in molecular and cellular techniques used in clinical cancer research (e.g. IHC, immunoassays, flow cytometry, qRT-PCR) and the utilization of genetic and genomic data in biomarker discovery (e.g. gene expression, copy number, mutation, DNA methylation
• Ability to design and execute experiments, and communicate findings in a clear and concise manner in both written and verbal form.
• Adept at managing multiple projects in an efficient and organized manner
Preferred qualifications:
• 2-3 year experiences in a pharmaceutical or clinical cancer research setting.
• Specific experience in the application of biomarkers during oncology drug development, including experience with assay qualification/validation and clinical translational research.
• Familiarity with existing and emerging platforms for biomarker discovery and evaluation.
• Experience with academic research collaborations, contract laboratories, budget management and drug development.
• Working knowledge of relevant regulatory guidelines/practices as it relates to use of biomarkers in clinical development and the development of companion diagnostics.
• Demonstrated ability to operate in a highly matrix environment.
Contact Information:
Dr. Yihong Yao: yihong.yao@cellbiomedgroup.com
Dr. Jiaqi Huang: jiaqi.huang@cellbiomedgroup.com
