生物医药初创公司管理职位更新-20201016

1）上海 CSO

肿瘤免疫生物学领域，博士，20年以上新药研发经验

2）上海 CMO 

MD/PHD，肿瘤领域15年以上临床研究经验

3）上海 溶瘤病毒研发Director/VP

MS/PHD, 5年以上相关工作经验

4）上海 AAV工艺总监或更高

PHD, 3年以上相关工作经验

5）上海 临床运营总监或更高

PHD, 10年以上相关工作经验

6）北京 生物药临床前开发VP

Qualifications

• Ph.D.; a minimum of 10 years industry experience in pharmaceutical companies and/or biotech companies working in infectious disease or immune diseases with Biologics is preferred.

• Excellent track record in building pipeline of high quality drug candidates;demonstrated success in driving pipeline through IND 

• Experience compiling R&D, preclinical and clinical study protocols, reports, and publications.

• Product development; has successfully brought products to the clinic, and has been responsible for pre-clinical sections of successful NDAs

• Proven track record developing and managing R&D strategic and operating plans, budgets as well as recruiting and managing a team in a biotech research environment

• Support preclinical development particularly in PK, PD and toxicology. Contribute to protocol design in terms of PK and PD sampling time/schedule and PD marker selection

• Provides vision and strategy for the future direction of company’s technology platform and product pipeline

7）北京 生物药CMC VP

· A minimum of 10 years of experience in CMC project management, development, scale-up and clinical/commercial development and manufacturing in the biotechnology or pharmaceutical industry

· Experience in leading and direct management of research, process development, and manufacturing

· Extensive experience in leading biological process and analytical development

· Experience in achieving regulatory approval of new drugs or biologicals Knowledge, Skills and Abilities:

· Good understanding of cGMP and FDA regulations and guidelines relating to CMC-related areas

· Knowledge of global CMC-related regulatory requirements and guidelines an advantage

· Excellent leadership, managerial and communications skills in a cross-functional environment

· Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications and regulatory submissions

· Prepared and managed the preparation of CMC regulatory filings

8）北京 生物药临床开发VP

Requirements:

• PhD in Pharmacology or MD required

• 10 years effectively leading and managing the global clinical operations function including 5 years management of multiple direct reports in the execution of all phases of global clinical trials (Phases 1 through 4)

• Expertise in the areas of global drug development, planning, management and execution of clinical trial operations

• Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.

• Demonstrated knowledge and collaboration with clinical data management for efficient planning of study monitoring, data collection and cleaning resulting in high quality data for analysis

• Demonstrated experience managing and mentoring clinical operations team members including negotiation and influencing skills while establishing clear and consistent goals and objectives

• Demonstrated knowledge of international clinical pharmaceutical standards including, ICH/GCP guidelines, and regulatory compliance in multiple countries and regions.

9）北京 生物药项目经理

任职要求：

1、生化/分子生物学、细胞生物学、免疫学或相关专业硕士以上学历；

2、能熟练掌握单克隆抗体/双特异性抗体制备技术，至少亲自参与过一个完整的单克隆抗体药物或双特异性抗体药物开发项目并成功取得临床批件，参与过单克隆抗体药物项目者优先；

3、5年以上抗体类药物项目开发工作经验，具备抗体药物研发项目管理经验优先；