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更新于 6月24日

(Senior) Medical Director(資深)腫瘤醫(yī)學(xué)總監(jiān)

3-6萬(wàn)
  • 南京建鄴區(qū)
  • 5-10年
  • 碩士
  • 全職
  • 招1人

職位描述

藥物研究腫瘤科Ⅲ期
Key Responsibilities: 1、Provide medical leadership and strategic oversight for oncology clinical development programs, particularly Phase 3 studies and registrational trials. 2、Lead or support the design, execution, and interpretation of global MRCTs, ensuring alignment with regulatory requirements and scientific goals. 3、Serve as the clinical point of contact for cross-functional teams, external partners, and regulatory agencies (e.g., FDA, EMA, NMPA). 4、Drive development of clinical sections for NDA/BLA submissions and participate in interactions with global health authorities. 5、Contribute to development of regulatory strategies including those supporting accelerated approval pathways (e.g., single-arm registration trials, Breakthrough Therapy Designation [BTD], Orphan Drug Designation [ODD]). 6、Collaborate closely with regulatory affairs, clinical operations, biostatistics, medical writing, and safety to ensure high-quality clinical program delivery. 7、Interpret and communicate complex clinical data internally and externally, including support of product labeling discussions and launch activities. 8、Provide medical and scientific leadership in rare cancer indications and/or tumor-agnostic development strategies when applicable. 9、Contribute to company strategy and decision-making on product development, lifecycle management, and indication expansion. Qualifications Required: 1、M.D. (or equivalent medical degree) with valid clinical training and at least 3 years of physician practice experience. 2、Hands-on experience in Phase 3 clinical trials in oncology. 3、Direct involvement in NDA/BLA submissions and successful regulatory interactions. 4、Experience with MRCTs and global development. 5、Demonstrated knowledge of FDA, EMA, NMPA, or other regulatory authority requirements and processes.

工作地點(diǎn)

建鄴區(qū)南京維立志博生物科技股份有限公司

職位發(fā)布者

高女士/人事

昨日活躍
立即溝通
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南京維立志博生物科技股份有限公司是一家臨床階段的生物科技公司,致力于創(chuàng)新療法的發(fā)現(xiàn)、開(kāi)發(fā)及商業(yè)化,以滿足中國(guó)及全球在腫瘤、自身免疫性疾病及其他重大疾病方面未獲滿足的醫(yī)療需求。公司憑借專有技術(shù)平臺(tái)及強(qiáng)大的藥物開(kāi)發(fā)能力,已設(shè)計(jì)合理且具差異化的包括12款創(chuàng)新候選藥物在內(nèi)的豐富管線,其中6款已成功進(jìn)入臨床階段。公司的腫瘤產(chǎn)品組合提供廣泛的癌癥治療選擇,在單一治療及聯(lián)合治療方面有巨大的潛力。公司將不斷拓展創(chuàng)新,為廣大患者提供安全、有效、可及、可負(fù)擔(dān)的新藥,滿足尚未滿足的醫(yī)藥需求。公司研發(fā)中心設(shè)立在南京市建鄴區(qū)南京新城科技園的“紫金(建鄴)科技創(chuàng)業(yè)特別社區(qū)”內(nèi),交通便利,區(qū)位優(yōu)越。同時(shí)在江北新區(qū)醫(yī)藥谷擁有7000m2中試生產(chǎn)基地在建。公司官網(wǎng)地址:www.leadsbiolabs.com公司福利:1.足額繳納五險(xiǎn)一金;2.周末雙休、帶薪年假、福利個(gè)假、法定節(jié)假日;3.年終獎(jiǎng)金、節(jié)日福利、高溫福利、員工關(guān)懷福利;4.交通補(bǔ)貼、午餐補(bǔ)貼、通訊補(bǔ)貼等;5.年度體檢、定期團(tuán)建、年度旅游;6.股權(quán)期權(quán)激勵(lì)。
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