南京招聘

      This position will contribute to the development and execution of the clinical strategy and plans for company’s I-O clinical programs. 

Roles & Responsibilities:

     This position provides medical and scientific knowledge to guide and support the strategy and execution of the clinical development plan, works collaboratively with multi-functional team members responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted, including:

1. Work with the team to design, plan, and implement the clinical studies including development of study specific documents such as protocols and informed consents, regulatory documents as well as performing data review and analyzes and assisting with site visits and training activities;

2. Work closely with CRO and sites to ensure proper training and adherence to the protocol and study timelines;

3. Establish long term relationship with the KOLs and investigators;

4. Review enrolment package to ensure the patients meet study inclusion/exclusion criteria;

5. Work with PV team member to review and track emerging safety data, and take actions as appropriate;

6. Support PV team of regular review of individual subject safety data and review of cumulative safety data with the PV;

7. Write protocol amendments, as necessary, to address safety, efficacy, or operational issues in collaboration with Clinical Operations and regulatory team members;

8. Perform clinical database review, cleaning, query generation and analysis of study results;

9. Review protocol deviations (PD) and other study specific documents as needed;

10. Assist in preparation of clinical content of regulatory submissions / documents / meetings;

11. Assist with preparation of abstracts, posters, presentations, and publications;

12. Present clinical trial results internally and to the clinical sites;

13. Other duties assigned by the Company.  

Qualifications & Key Attributes: 

1. Patient-focused, with deep commitment to understanding needs and improving the lives of patients and a passion for developing novel therapeutics;

2. Motivated to work in a fast-paced, high accountability, small company environment;

3. A "can do" and collegial professional who leads through influence and interpersonal skills;

4. Capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to details;

5. Strong Chinese-English bilingual written and oral communication skills, including presentation skills;

6. Ability to analyze and interpret data and develop written reports and presentations of those data;

7. Strong critical, strategic, and analytical thinking skills. 

Education & Experience Requirements:

1. Medical degree (Medical oncologist is a plus)  with experience in clinical practice and 2-5 years of experience in the conduct of clinical trials in an industry setting (Pharma or CRO);

2. Experience in aspects of study conduct, including medical monitoring, data review and cleaning, protocol writing, start-up, study execution, analysis and reporting;

3. Experience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators and other site personnel involved in clinical trials. 

南京维立志博生物科技有限公司是由留学美国并工作多年的美籍华人药物研发专家和企业家在南京市创立的一家生物制药公司，主要从事研究和开发抗肿瘤、治疗自身免疫或传染性疾病等方面原创性的抗体新药。公司运用具有世界先进水平的抗体药物研发的核心技术，正在研发多个具有自主知识产权的的一类抗体新药。
公司研发中心设立在南京市建邺区南京新城科技园的“紫金（建邺）科技创业特别社区”内，交通便利，区位优越。
公司招聘有进取心和创业精神研发技术员，作为公司的研发团队成员。公司正处在快速发展阶段，为公司团队的每个成员提供了广阔的成长机会和空间。