上海招聘

Responsibilities:

The Position

Basic Function:

Provides medical direction of all Oncology programs, plans and implements drug development strategies, clinical trial designs, safety evaluations and regulatory submissions.

Primary Responsibilities include:
Drafts clinical development plan with the support from clinical project team.
Assesses the global study feasibility, designs and writes local or regional clinical study protocols, assures protocols will adhere to standard clinical practices, and develops the case report form with data management team.
Builds strong relationship with KOLs and maintains the contact, selects suitable clinical consultants for clinical trials or therapeutic area
Works with operation team to resolve the issues during the study conduction, monitors patients safety in the ongoing clinical studies
Secures the conditions essential for safety, efficacy and medical usefulness of a drug
Works closely with biostatistics and decides how the resulting data should be analyzed.
Preparation of abstracts, posters and publications
Drafts clinical study report, NDA submission and response to regulatory enquiries.

Requirements:

l M.D. degree with specialty training in Oncology disease, he/she should have soundable medical knowledge in this therapeutic area.
l More than 2 years in clinical practice in Oncology department, and has the experience taking caring dialysis patients
l At least 2-3 years clinical research experience in pharmaceutical industry or academic institute specifically in the Oncology therapeutic area (focus on study design).
l Excellent communication and influence skill with different stakeholders (Chinese and English)
l Established relationship with Key Opinion Leaders & Investigators, especially for renal and metabolic diseases (at least a brief name list)
l Excellent ability of innovation, independent leading, and strategic thinking (at least a real case to demonstrate)
l Excellent ability of project execution (at least a deep understanding of execution)

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罗氏药品临床研发亚太中心

罗氏药品临床研发亚太中心位于上海张江高科技园区，是罗氏在中国乃至亚太地区（不包括日本在内）第一个全功能临床药品开发中心，是罗氏药品开发部在全球的第五个研发地区。其前身为2007年10月成立的罗氏药品开发中国中心。

罗氏于2007年在中国率先设立全球药品开发中心，成为在华完成且体现药物研究、药品开发、生产制造和市场销售环节等整体价值链布局的跨国制药企业。此举不仅将加快新药在华的上市时间，使国内广大患者有望更早地受益于创新药物，而且将让更多的中国研究机构、学者、临床医生更早、更主动地参与到全球创新药物的开发过程。

罗氏药品开发中国中心从事药品开发工作，是把经过实验室筛选的分子转变成药物的关键一环，它通过国际多中心临床研究，鉴定药物的安全性和有效性，是驱动药物价值链的引擎。罗氏药品开发中国中心于2009年9月升级为罗氏药品临床研发亚太中心，负责罗氏在亚太地区的药品开发，令更多中国乃至亚太地区的患者尽早受益。