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=1728938

Job Purpose:

To provide strategic medical guidance for and to the lead the development of experimental oncology agents in the OTM portfolio, beginning with the candidate selection phase (CSP) of preclinical development and continuing through clinical proof-of-concept (PoC).

Major Activities (Describe 8-12 main activities):

?Leads the EPT, reports to clinical head and OTM LT;

?Provides strategic medical guidance for the development of new oncology agents (both small molecules and biologics) that are in preclinical development, typically beginning at the candidate selection phase (CSP);

?The CPL is specifically responsible for creating a clinical development strategy for new oncology agents that are within the CSP to PoC timeframe. The development strategy combines the CPL’s medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Oncology Biomarkers and Imaging, Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy;

?Although registration studies are not within the responsibility of OTM, the CPL in OTM must provide an early clinical development strategy that foresees and supports subsequent registration trials;

?The CPL is the leader for Early Program Teams (EPTs), beginning at the time of sPOC approval (approval to conduct GLP toxicology studies to enable the start of clinical development) and continuing through those clinical trials needed to demonstrated PoC;

?The CPL integrates preclinical information (pharmacology, toxicology, pharmacokinetics) and interprets its implications for clinical development, as articulated in the Investigator’s Brochure and first-in-human protocol;

?The CPL collaborates with clinical scientists to develop clinical protocols for OTM compounds and to develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports);

?The CPL applies his or her medical knowledge to guide the safe, ethical and efficient conduct of the trials under his or her responsibility. He or she is knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them;

?The CPL liaises with outside experts, investigators, and regulatory authorities in the field of oncology, and represents his or her projects to those groups and authorities;

?The CPL writes and reviews abstracts/manuscripts, etc. for presentation/publications at internal/external meetings;

?The CPL participates in task forces to support continuous improvement and other management objectives.

Education:

?MD or DO degree required. Board-certification in an oncology specialty is preferred.

Languages: Fluent English – Oral and written

Experience/Professional requirement:

?Needs 3-5 pharma/biotech industry experience in oncology clinical trials and the equivalent term experience in the academic setting In case of no industry experience, substantially longer academic experience in translational oncology and substantial clinical study experience;

?Must have facility with the interpretation of preclinical data in oncology (molecular biology, pharmacology, pharmacokinetics, and toxicology);

?Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials;

?Proven ability to analyze and interpret efficacy and safety data relating to oncology;

?Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology;

?Excellent medical/scientific writing skills;

?Effective written and oral communication skills;

?Proven ability to manage and develop a team;

?Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies.

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。