上海招聘

Primary Function主要职能:

Be accountable for the implementation, management and reporting of assigned clinical trials, drive the execution of the clinical studies in compliance with ICH-GCP, including but not limited to study planning, study start-up, execution, control study budget and quality, monitor progress, CRO/vendor selection and management, develops and manage all study plans in collaboration with the CRO if applicable.

Be a key member of product project team working closely with R&D key functions on product development plan and execution, provide input and contribute from clinical operation function.

Major Responsibilities and Duties主要职责和任务:

Ensure successful clinical trial startup and conduction, accountable for all study aspects and ensuring meeting timeline, budget and quality requirement.

1. Support IND filing on study related documents preparation, e.g. protocol, ICF, IB etc.

2. Manage study planning and startup all activities including not limited to country/site selection, FDA/NMPA submission, study TMF preparation, vendor/system set

-up, Clinical trial materials planning and readiness at depot, study plan development etc.

3. Manage trial enrollment and monitor overall progress, make mitigation/action plans and execute ensuring enrollment hit target.

4. If applicable, lead company functional team on CRO selection, manage and monitor performance of all CROs ensure delivering on time and high quality.

5. Manage several of clinical vendors’ contract and overseeing their performance

6. Have responsibility for the financial management of the clinical trial including budget planning, resource allocation and preparation of quarterly reports.

7. Train and coach CRAs in various aspects of management (e.g. HR, budgets, and resource allocation) that are relevant to project issues

8. Work as product level project team member and contribute from clinical operation perspective.

9. Identify/monitor risks, and develop mitigation, contingency plans as necessary

10. Serve as a liaison for company with our overseas or domestic clinical CROs

Qualifications资格要求:

1. Medical degree and above

2. Major in clinical medicine, pharmacy or relevant;

3. Experienced in clinical trial area and preference on

? >6 years clinical trial related experience & >3 years trial management

? previously worked in global pharma or CRO and/or early development functions

4. Knowledgeable to China regulatory and clinical requirements, with experience of interacting with regulatory agencies, e.g. FDA, NMPA

5. Solid understanding of GCP and Drug development

6. Ability to work independently and collaborate

7. Strong communication skills and leadership

8. Strong oral and written communication skills in Chinese and English 

安萌得医药坐落于上海市临港浦江国际生命健康城，2020年被认定为高新技术企业，安萌得医药科技有限公司是一家临床阶段的生物制药公司，是由美籍华裔科学家范国煌博士和加籍华裔科学家王建飞博士主导的新药研发公司。公司专注于研发全新靶点，致力治疗恶性肿瘤、自身免疫性疾病、代谢性疾病和神经退行性疾病等重大疾病的全球小分子或大分子新药，并不断实现创新药开发的里程碑式跨越。安萌得在小分子和大分子新药研发技术平台上，目前已有2个自主研发产品获批FDA并进入临床阶段，同时拥有多个在研全球创新药，以每年完成至少2个项目IND申报的速度快速发展，从而实现从早期研发型生物技术公司向生物制药公司的蜕变。于2018和2021年分别成立上海研发中心、澳大利亚全资子公司和美国全资子公司，以实现全球化布局