Investigator II
CNIBR-诺华（中国）生物医学研究有限公司
- 公司性质：外资(非欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-10-14
- 工作地点：上海-浦东新区
- 招聘人数：若干
- 工作经验：三年以上
- 学历要求：博士
- 职位类别：生物工程/生物制药 临床数据分析员
职位描述
Job Purpose
Manage projects (with a TA focus), interpret and present information and negotiate an optimal PK/PD strategy for early and late development in liaison with TA-PK Head and appropriate line functions. Responsible for the PK, PK/PD and M&S component of study protocols, reports and project summaries within agreed timeframes and which meet regulatory requirements. Take the lead on appropriate pharmacokinetic /biopharmaceutical studies.
Major Accountabilities
?Define PK, PK/PD, biopharmaceutical and M&S requirements in project (nonclinical and clinical) development plans and appropriate strategies for global registration.
?Analyze, interpret and represent PK, PK/PD and M&S data generated during development and provide guidance.
?Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally.
?Directly or indirectly take the lead on appropriate pharmacokinet-ic/biopharmaceutical studies.
?Prepare summary information for internal and external Advisory panels, Investigator meetings and Health Authorities as part of the regulatory approval process. This includes PK/PD components of IND applications in the US, CTX in other countries.
?Represent the PK/PD discipline and ensure high quality interactions with various health authorities, external investigators, and various internal Novartis Disease Area experts
?Coordinate with appropriate sub-team members and other LF experts and/ or prepare (when needed) summary documentation on drug metabolism and pharmacokinetics as required by ethics committees and HAs (IB, BB, CTA/IND, responses to HAs).
?Prepare, compile and review appropriate sections of CTD dossiers /NDA documents.
?Contribute to and support continuous improvement initiatives in global pharmacokinetics and partner functions
Ideal Background
Education: Ph.D. in Pharmaceutical Sciences, or related disciplines (or equivalent degree/knowledge/expertise)
Languages: fluent English and Chinese (spoken and written)
Experience: 3-4 years of experiences in drug development or a relevant environment
Manage projects (with a TA focus), interpret and present information and negotiate an optimal PK/PD strategy for early and late development in liaison with TA-PK Head and appropriate line functions. Responsible for the PK, PK/PD and M&S component of study protocols, reports and project summaries within agreed timeframes and which meet regulatory requirements. Take the lead on appropriate pharmacokinetic /biopharmaceutical studies.
Major Accountabilities
?Define PK, PK/PD, biopharmaceutical and M&S requirements in project (nonclinical and clinical) development plans and appropriate strategies for global registration.
?Analyze, interpret and represent PK, PK/PD and M&S data generated during development and provide guidance.
?Proactively manage links with other functions to ensure that pre-clinical and clinical PK/PD information are used optimally.
?Directly or indirectly take the lead on appropriate pharmacokinet-ic/biopharmaceutical studies.
?Prepare summary information for internal and external Advisory panels, Investigator meetings and Health Authorities as part of the regulatory approval process. This includes PK/PD components of IND applications in the US, CTX in other countries.
?Represent the PK/PD discipline and ensure high quality interactions with various health authorities, external investigators, and various internal Novartis Disease Area experts
?Coordinate with appropriate sub-team members and other LF experts and/ or prepare (when needed) summary documentation on drug metabolism and pharmacokinetics as required by ethics committees and HAs (IB, BB, CTA/IND, responses to HAs).
?Prepare, compile and review appropriate sections of CTD dossiers /NDA documents.
?Contribute to and support continuous improvement initiatives in global pharmacokinetics and partner functions
Ideal Background
Education: Ph.D. in Pharmaceutical Sciences, or related disciplines (or equivalent degree/knowledge/expertise)
Languages: fluent English and Chinese (spoken and written)
Experience: 3-4 years of experiences in drug development or a relevant environment
公司介绍
诺华（Novartis AG）是全球医药保健行业的领导者。其核心业务涉及专利药，非专利药，眼睛护理，消费者保健和动物保健等领域。诺华公司总部设在瑞士巴塞尔，业务遍及全球140多个国家和地区。
诺华（中国）生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所（NIBR）的第八个研究基地。我们位于中国上海市张江高科技园区，将成为诺华在亚洲的主要研究中心，以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法，用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段，研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验，进行安全性研究，生物标志物和检测分析，表达谱、生物分析以及转化医学的研究。
随着公司业务的迅速扩展，我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。
诺华（中国）生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所（NIBR）的第八个研究基地。我们位于中国上海市张江高科技园区，将成为诺华在亚洲的主要研究中心，以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法，用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段，研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验，进行安全性研究，生物标志物和检测分析，表达谱、生物分析以及转化医学的研究。
随着公司业务的迅速扩展，我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。