北京招聘

Responsibilities:
1. Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
2. Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
3. Co-monitors as needed.
4. Develops and tracks study timelines, budget, and quality metrics.
5. Ensures appropriate clinical resources are available for the clinical project.
6. Ensures GCP and regulatory compliance is maintained.
7. Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
8. Maintains professional expertise through familiarity with therapeutic area and clinical research literature.
9. Manages clinical projects from concept through clinical study report completion.
10. Oversees clinical research study conduct.
11. Manages, mentors, and develops direct reports.
12. Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources.
13. Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts.
14. Participates in meetings with investigative sites, key opinion leaders and consultants as needed.
15. Plays a part in the analysis, summary, and reporting of clinical data through the course of the study.
16. Aides in the training and development of all clinical staff members.
17. Performs other duties as assigned.
18. Proactively identifies and resolves issues and participates in process improvement initiatives as required.
19. Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
20. Reviews and approves invoices from study vendors, investigators, consultants, etc.
21. Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken.
22. Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks.

Requirements:
1. Bachelor’s degree or above in a scientific discipline or equivalent with more than 10 years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience.
2. Conscientious, influential person with an outstanding work ethic and strong personal discipline.
3. Excellent organizational, leadership and problem-solving skills.
4. Excellent written and verbal communication skills.
5. Experience in leading cross-functional teams to meet goals and metrics.
6. Success at managing global studies a plus.
7. Know-how in managing Phase I, II, & III clinical studies.
8. Experience in writing clinical study protocols, informed consent forms, and other clinical documents.
9. Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
10. Solid understanding of FDA and other regulatory requirements that may impact global clinical studies.
11. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
12. Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities.
13. Working knowledge of project development and update of clinical study timelines.
14. Other tasks assigned by leaders.

和铂医药是一家专注于肿瘤免疫领域创新药物研究与开发的全球化运营生物医药公司。公司将运用其拥有的全部自主知识产权的全人源单抗的转基因鼠系列核心技术平台，建立下一代治疗性肿瘤抗体药物产品管线,并将围绕Harbour的两大平台拓展合作与授权业务。公司总部及研发基地位于中国上海，另外在美国马塞诸塞州剑桥设立商业运营中心，在荷兰鹿特丹设立抗体研发平台创新中心，在波士顿地区设立了创新中心包括实验室和研发团队，也将在江苏昆山设立研发基地。公司拥有资深管理团队以及丰富的药物研究与开发经验。和铂医药要为满足中国及全球病人的需求而不断努力，依托拥有自主知识产权的核心技术平台,创建一个在肿瘤治疗领域有科学与技术领导力的国际性生物医药公司。同时, 在药物研发领域建立以技术平台为基础的对外合作，整合新的技术，推动中国整个抗体研发产业的进步。

Company Overview
Harbour BioMed is a global biotechnology company discovering and developing innovative therapeutics for cancer with a focus on immuno-oncology and autoimmunity/inflammation. The company's discovery and development programs are centered around its two patented transgenic mouse platforms for human antibody discovery.
The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selective preclinical and clinical stage asset acquisitions. Harbour BioMed also licenses the platforms to companies and academic institutions through its Harbour Antibodies subsidiary.
Harbour BioMed has headquarters and an R&D site in Shanghai, business operations in Cambridge, MA, and antibody platform development in Rotterdam, The Netherlands.
The company has an innovation center including research lab and a development team in Boston. Also, we are expanding to Kunshan site in Jiangsu for our R&D operation.