职位详情

登录

Clinical Research Physician
2.5-3万
人 · 博士 · 2年及以上工作经验 · 性别不限2024/10/22发布
五险一金补充医疗保险免费班车餐饮补贴绩效奖金定期体检

浦东新区

低价好房出租>>

祥科路298号佑越国际209室

公司信息
南京传奇生物科技有限公司

合资/1000-5000人

该公司所有职位
职位描述
Job Description:
1.Therapy Area Expertise
–Act as senior technical/medical expert for oncology/haematology products in development and medical support activities.
–To exhibit a high level of knowledge on medical and development when working with other function lines like Drug Regulatory Affairs, operation and commercial.
2.Logistics Support.
–To alert local teams of advances and new data from global sources.
–Ensure and oversee the scientific quality of presentation and publications made by China Development team members.
–Lead and manage the China Project Team (CPT) to meet the specific development timeline and to ensure maximum efficiency in new drug development and registration.
–Undertake specific additional projects related to clinical development as may be required by the Clinical Development head from time to time
3.Clinical Development
–Timely catch up with and understand development plan and progress. Understand China clinical needs, practices and environment to perform evaluation on how pipeline opportunities, risk & benefits are in China.
–Lead clinical strategy development, oversee clinical projects plan. The CD manager is expected to manage multiple projects/ ongoing work activities of high complexity within their own business line or sub-function.
–To Lead and direct a cross-functional Project Team - the China Project Team (CPT) to assure the successful establishment of new drug development and registration strategy, which meets the specific development timeline and also ensure maximum efficiency. During the CPT practice, the CDP demonstrates extensive industry knowledge when perform tactical assessment of country capability, disease prevalence, treatment guidelines, competitive landscape, business interest; medical availability etc to aid appropriate placing of studies. Provide input into appropriate prioritization of studies, consistent with local and regional strategy, balancing the short term and long term local business needs.
–Develop and leverages resources to implement the development of appropriate clinical trial protocols, synopsise and summaries to support development strategies.
-Discuss protocols with KOLs, global teams and local DRA and partner
-Ensure input into Development plans from Medical Affairs and marketing functions especially around planning for optimum approved label.
-Provide strategic input to publications/publication plans of clinical trials for registration, supervise writing, write and review abstracts, manuscripts for presentation/publication at internal/external meetings.
-Clinical Trial Application [CTA] and New Drug Application [NDA] clinical dossier support and preparation including CSR preparation
-Prepare, attend meetings and interact with Health Authority at specific meetings or on ad hoc basis. Provide expertise to cross-functional groups in preparations for HA interactions.
-Make decisions regarding eligibility, enrolment and data consistency.
-Contribute to the ongoing scientific review of the clinical trials.

Requirement:
–Medical doctor with clinical experience and preferably post-graduate degree in the field of oncology/haematology or related biomedical field.
–Significant training/experience [at least 3 years] in clinical development in the pharmaceutical industry or equivalence
–Track record of scientific achievements in clinical research
–Advanced Medical/scientific and state-of the art clinical research knowledge in oncology/haematology
–Familiar with all aspects of the drug development process
–Expert in clinical trial design.
–Proven ability to interpret, discuss and represent efficacy and safety data in the oncology/haematology field.
–Advanced medical/scientific writing skills
–Superior English writing, reading, speaking and listening skills and attention to detail
–Strong communication skills within a multidisciplinary team and in interfaces with other departments and headquarters
–Strong Sense of responsibility and dedication
–Teamwork spirit
–Skilful at Word/Excel/Access/PowerPoint/Microsoft project.

相关职位
临床医学2.5-3万
培训方案
高级临床研究医生(血液)(J10257)2.8-5.5万·14薪
公租房申请
新药临床研究员30-35万/年
做五休二
临床研究30-40万/年
五险一金
(高级)临床研究医师-代谢内分泌(J19218)2.5-4.2万·14薪
查看所有职位
51米多多提醒你:在招聘、录用期间要求你支付费用的行为都必须提高警惕。 以招聘为名的培训、招生,许诺推荐其他工作机会,甚至提供培训贷款,或者支付体检 、服装、押金和培训等费用后才能录用工作的,都属于违法行为,应当提高警惕。一经发现,请立即举报,并向当地公安机关报案。

举报

招聘信息 > 上海招聘 > 生物制药招聘 > 上海临床研究员招聘

收藏

热门职位热门城市周边城市