職位描述
該職位還未進行加V認證,請仔細了解后再進行投遞!
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
地址:南京建鄴區建鄴區南京維立志博生物科技股份有限公司
??
點擊查看地圖
詳細位置,可以參考上方地址信息
求職提示:用人單位發布虛假招聘信息,或以任何名義向求職者收取財物(如體檢費、置裝費、押金、服裝費、培訓費、身份證、畢業證等),均涉嫌違法,請求職者務必提高警惕。
職位發布者
維立志博..HR
南京維立志博生物科技有限公司
-
制藥·生物工程
-
21-50人
-
公司性質未知
-
建鄴區嘉陵江東街18號3棟711室

應屆畢業生
學歷不限
2026-02-27 10:13:21
769人關注
注:聯系我時,請說是在江蘇人才網上看到的。
