Clinical Research Physician(45-60万)

职位摘要

行业类型

生物制药

招聘人数

1

职位性质

全职

工作地点

上海

薪酬范围

45-60万

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我司正在为某global top pharma招聘以下职位:Clinical Research Physician
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职位概要 Job Highlights:

一线外企平台上市前职位,不分瘤种,项目多

职责描述 Key Accountabilities:

One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission.

Clinical research physician will play key leadership role for the clinical development in China. This individual will be responsible and accountable for the development of best China development plan. Clinical research partners closely with headquarter project development team, China regulatory affair, medical affair, project management, clinical trial operation, commercial team for flawless plan and execution of China registration strategy. This individual is expected to be responsible for different programs across MSD therapeutic franchise.

This individual will serve as the key interface between headquarter project development team and China MSD development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician will represent clinical development team of China development center on HQ project team as needed and this individual is expected to address issues/questions raised by HQ team and provides feedback to HQ project team from China prospective. This individual should have excellent communication skill with demonstrated language skills in both written and verbal English and Chinese.

Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol. We place high value on efficient, feasibility, most desirable labels, and cost effective, necessitating careful collaboration with operational experts such as colleagues from global clinical trial operation. The clinical monitor will interpret, prepare clinical study reports, regulatory dossier, regulatory responses, and review product label. The clinical research physician will also prepare and review manuscript for publication.

The clinical research physician will also function as clinical monitor for study protocol. In this role, this individual will work with study team to ensure safety/efficacy information adequately captured and review serious adverse events. Clinical research physician will review and approve monitoring plan/reports/data listings

To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders (KOLs) and internal key stakeholders such as medical affair, and marketing and regulatory affair etc. The clinical physician will be involving in introducing new MSD compounds in development to China KOLs and seek feedback for our clinical development plan as needed.

The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Other key points of contact in the organization will include emerging market development colleagues in US, project team in US, regulatory affair colleagues in China, medical affair, project management, and clinical trial operation.

Requirements
MD or PhD in in clinical medicine.
Previous experience of clinical research is highly desirable.
The candidate who is ideally suited for this position will be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful.
The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
Excellent language skills in both English and Chinese (fluent in verbal and written), previous track record of protocol and study report writing is highly desirable.
The position may require the flexibility to work outside of the area of primary medical specialization.

职能需求 Competence Profile:

实体瘤
上市前经验
英语

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