上海招聘

Interested candidte please visit the following URL to apply for the job online (候选人请务必点击以下链接进行在线申请):

https://sjobs.brassring.com/2052/ASP/TG/cim_jobdetail.asp?partnerid=13617&siteid=5271&jobid=1847310&codes=CN14

Responsibilities:

1. Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.

2. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.

3. Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

4. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management.

5. In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.

6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.

7. Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and OTM Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and OTM management to ensure appropriate line function allocation.

8. Sits on Early Program Team (EPT) to contribute to program strategy.

9. Lead or be a key contributor to the development of program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans), where applicable. Ensure that these are applied across all trials to ensure consistency of clinical dossier.

10. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties; manage interface with external vendors in cooperation with the CRO Management Department.

11. For OTM trials led by a US-based CTL, function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL be the primary contact for US sites for clinical conduct of the trial.

12. Participate in the hiring, on-boarding, and training of new staff. Mentor OTM staff. May serve as faculty member for training programs.

13. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.

14. Represent OTM ClinOps on OTM or Novartis global initiatives. Serve as Subject Matter Expert within OTM, as appropriate.

Keywords: CNIBR, NIBR China, NIBR Shanghai

Requirements:

Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD preferred.

Fluent English (oral and written).

≥ 6 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.

Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.

Advanced knowledge of oncology and/or hematology, OR experience in early clinical development.

Hands-on experience in data cleaning and analysis required.

Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).

Proven experience in developing effective relationships with key investigators.

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。