Drive clinical program through approval and commercialization

Build company infrastructure and team

Develop high quality business strategies and plans ensuring their alignment with short-term and long-term objectives

Oversee in-depth market and competitive analysis across all business fields, regions and customer segments in a structured manner.

Clearly analyze business development needs and explore new opportunities.

Manage R&D, Pre-clinical, Clinical & Manufacture teams.

Lead or participate in talent acquisition, accurately evaluate talents’ capabilities, and select qualified candidates according to company procedures.

Track and keep up with advanced management experiences; lead or participate in optimizing and restructuring company’s business model/procedure and regulations.

Lead and initiate corporate cultural development activities.

Actively promote company’s vision, and core values, as well as positively interpret company’s cultural orientation and code of conduct.

 Responsible for overall clinical development strategic planning and implementation (phase I-III), including clinical sciences, regulatory affairs, Clinical trials, safety monitoring and data management.

Establish external alliance with key clinical centers, KOLs, and regulatory agencies for effective clinical trial implementation. Collaborate effectively with internal stakeholder in key account strategic planning to ensure the information needs from managed markets healthcare professionals are met.

 Responsible of overall Clinical team management, Build and lead an effective clinical development team by attracting and retaining clinical top talents.

Provide clinical expertise to advance scientific and business objectives.

 Ph. D degree, Clinical medicine, oncology or biomedicine education background. Familiar with oncology or immune related regulation policy.  

 Relevant clinical research/development experience in oncology and/or hematology working at a pharmaceutical/biotech company. This is must be demonstrated by leadership in at least one global development program which led to successful registration of key product in major markets including China, etc.

Demonstrated ability of strategic thinking and contingency planning with respect to pharmaceutical objectives.

Demonstrated influence, negotiation and conflict resolution skills.

Good problem solving skills for developing creative solutions.

Good command of English skill including listening, speaking, reading and writing.

Responsible for building and managing the CMC group to support the development innovative drugs in the R&D pipeline.

Trough budget management, simplification and optimization of CMC operations and workflow to maximally improve the operational efficiency while maintaining full compliance.

Strengthen subordinates’ career development and management skills through providing coaching/mentoring and guidance/directions, provide technical support for new process /technology and evaluation to enhance the overall development capabilities.

Supervise the CMC team to define project goals, timeline and work activities. Provide technical and management support to ensure timely projects progress/completion.

PH.D in Pharmaceutical science or related science, 10 years of experience in global pharmaceutical companies.

Excellent skills in managing direct reports and projects, Ability to lead a large group of scientific staffs and a large portfolio of development programs.

Must be familiar with requirement of FDA, EMA and CFDA regulations, ICH guidelines and GMP/GLP as well as drug product development process.

Extraordinary problem solving and technical capabilities.

Good command of English skill including listening, speaking, reading and writing

Work with Immuno-oncology leaders to discover and develop new therapeutic modalities for cancer immunotherapy

Serve as project team lead on cellular immunotherapy and therapeutic antibody programs in the areas of immune-oncology and oncology, managing timelines, milestones, budgets and objectives

Manage a team of scientists focusing on in vitro immune cell functional assays

Develop and evaluate new approaches in research and make intellectual property submissions

Ph.D. in Immunology or related discipline

3+ years of postdoctoral training with a working knowledge of tumor immunology, 3+ years of biotech/biopharmaceutical experience in immunology/oncology

Extensive experience with immune cell model systems, in vitro functional assay development and drug-candidate validation

Recognized as a leader in the field with a strong publication record in the areas of inflammation, autoimmunity, and/or immuno-oncology.

Proven interpersonal and communication skills and enthusiasm for participating in a fast-paced environment of rigorous science and innovative thinking

Excellent managerial and supervisory skills

techniques employing molecular biology, biochemistry, structural modeling for antibody affinity maturation and antibody stabilization.

Drive efforts to design and optimize bispecifc antibody formats to support cell therapy and therapeutic antibody programs.

Serve as project team leader, manage project progress and timeline, and provide regular updates in achieving the specific objectives of the respective research projects.

Work cross-functionally as part of internal multi-disciplinary teams, coordinating lead isolation, optimization and characterization.

PhD with 2-3 years, or MS with 5-7 years of experience in Molecular Biology, Biochemistry, Structural Biology or related discipline.

Industry experience strongly preferred, prior experience of therapeutic antibody discovery projects a plus.

Expertise utilizing techniques for antibody engineering, antibody humanization, affinity maturation and antibody stabilization.

Familiarity with antibody properties and sequences, hands-on experience using MOE, Discovery Studio, Schrodinger, Rosetta or similar tools for protein structure modeling a strong plus.

Excellent data management, written and presentation skills and a team player.

负责关键原辅料的质量检验和结果判定；

负责生产过程的质量监控；

负责质量问题的原因调查，以及改进措施的跟踪；

负责评估生产工艺或控制方案的合理性，持续推动质量改进；

负责质量数据的统计和分析，每季度提交质量分析报告。

生物相关专业背景，本科及以上学历；

1年以上工作经验，了解细胞制剂生产流程及业务现状；

CET-4及以上，具备良好的英语读写能力；

具有优秀的沟通协调能力，分析和解决问题的能力强。

负责中间产品，终产品相关质量检测及结果判定；

负责质量问题的原因调查，以及改进措施的跟踪，问题解决；

参与评估生产工艺或控制方案的合理性，持续推动质量改进；

负责检测质量数据的统计和分析，每季度提交质量分析报告。

其它上级交代的工作；

生物相关专业背景，研究生及以上学历；

2年以上工作经验，了解细胞制剂生产流程及业务现状；

具有扎实的免疫学，细胞检测技能，具有敏锐的发现问题，分析和解决问题的能力。

CET-6及以上，具备良好的英语读写能力；

沟通协调能力强，执行力强，具有责任心和抗压能力；