临床药理总监

面议

成都市

刷新时间：2020-05-21

职位描述

工作职责：
1、负责指导临床方案中临床药理相关研究内容的撰写，为药物临床安全性及有效性研究提供相关技术支持。
2、评估创新药物的临床前数据，并运用相应模型手段预测药物的人体处置特点，指导临床研究的剂量设计。
3、参与临床药效学研究（PD）的设计和实施，比如生物标记物（biomarker）和终点的选择等。
4、协调解决跨部门合作中出现的与药物安全性、有效性及药物代谢动力学相关的问题。
5、与临床专家及审评专家进行专业沟通，为临床研究设计提供科学和法规支持。
6、负责相应团队的建设与管理。
任职要求：
1、学历要求：博士学历。
2、专业要求：临床药理相关专业。
3、工作经验：
（1）至少5年以上临床药理相关工作经验。
（2）至少完整负责过5个以上临床药理相关项目。
4、能力要求：
（1）精通临床药理和药物代谢动力学相关知识，熟悉药物开发流程，具有一定的临床研究经验。
（2）熟练运用GastroPlus, SimCYP等模型工具预测人体PK/PD特点。
（3）熟悉全球药物研发中临床药理相关法规政策，能与监管部门沟通协调研究过程中各项事宜。
（4）了解常用的数据处理和统计分析方法。
5、职业素养：积极敬业、主动进取、责任感强、正直向上。
6、语言要求：良好的中、英文阅读和写作能力。
临床药理总监/Director of Pharmacology

Position Summary
The Director of Clinical Pharmacology at Klus Pharma Inc. has key roles to play in influencing the discovery and development of drugs. The ideal candidate embraces model-based drug development - constructs, validates, and utilizes disease, placebo, exposure-response, and mechanistic PK/PD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other R&D partners. This position is also responsible for planning and direction of clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including protocol preparation; clinical phase oversight, and reporting).

Leadership Responsibilities
• Provide strategic and tactical direction to multiple project teams
• Evaluate new CROs
and other vendors for conforming with Klus Pharma Inc. quality controls.
• Review, summarize and integrate complex data sets across multiple disciplines.
• Manage the preparation and presentation of nonclinical safety data for project teams, portfolio management presentations, and internal /external partners and scientific groups.
• Provide strategic advice to project teams and senior management including evaluation of conclusions and potential impact of results on program and clinical/regulatory strategy.
• Generate yearly budgets to support programs.
• Directly interface with contract research organizations (CROs) to request quotes and derive cost estimates and work closely with Research to develop program budgets.
• Maintain a current understanding of regulatory requirements and guidance.

Core Responsibilities
• Act as Clinical Pharmacology representative on Clinical Science Team and Development Team as appropriate.
• Participate in implementing model based drug development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.

其他要求

招聘人数：1人
职能类别：药理/毒理/药效

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。