1. 作為產(chǎn)品研發(fā)核心團(tuán)隊(duì)(GPT)的成員,組織并推動(dòng)團(tuán)隊(duì)對(duì)所負(fù)責(zé)的創(chuàng)新藥產(chǎn)品制定臨床研發(fā)戰(zhàn)略與臨床試驗(yàn)計(jì)劃,通過制定綜合性、跨職能的近期、中長(zhǎng)期研發(fā)計(jì)劃,推動(dòng)和指導(dǎo)研發(fā)策略的實(shí)施,對(duì)產(chǎn)品研發(fā)進(jìn)行全過程、全方位的管理。 Be responsible for elaboration of clinical
development program strategy and planning as Global Program Core Team member,
drive and guide the implementation of clinical development strategy, manage and
control all the phases of clinical trials with all dimensions by establishing
integrated, cross-functional, short-term and long-term program plans.
2. 擔(dān)任負(fù)責(zé)產(chǎn)品的研發(fā)計(jì)劃和相關(guān)信息收集與溝通的關(guān)鍵聯(lián)系人,建立并維護(hù)產(chǎn)品核心研發(fā)團(tuán)隊(duì)內(nèi)外部順暢的溝通渠道,確保產(chǎn)品開發(fā)信息的充分、及時(shí)、全面溝通,推進(jìn)問題的發(fā)現(xiàn)和解決。 Serve as key contact for Clinical Development
Program and related information, establish and maintain appropriate
communications channels within and outside the Clinical Development Program
(CDP) Core Team, ensure sufficient and timely flow of information and
communication, promote the identification and solution of problems.
3. 負(fù)責(zé)跟蹤在研產(chǎn)品多項(xiàng)臨床試驗(yàn)的進(jìn)度與狀態(tài),同時(shí)確保不同報(bào)告系統(tǒng)中,產(chǎn)品研發(fā)信息的一致性、準(zhǔn)確性和完整性,負(fù)責(zé)產(chǎn)品研發(fā)信息對(duì)內(nèi)和對(duì)外溝通,負(fù)責(zé)向管理層定期報(bào)告研發(fā)進(jìn)展。 Document program progress and status of clinical
trials and ensure consistency, correctness and completeness of information of
the clinical trial in the different reporting systems, serving as the source of
valid project information for internal and external communications; be
responsible for routine progress reporting to the senior management.
4. 負(fù)責(zé)定期組織和協(xié)調(diào)產(chǎn)品研發(fā)關(guān)鍵會(huì)議(包括并不限于研發(fā)策略制定會(huì)議、風(fēng)險(xiǎn)管理會(huì)議,經(jīng)驗(yàn)教訓(xùn)討論或研發(fā)預(yù)算會(huì)議),確定產(chǎn)品研發(fā)的關(guān)鍵成功因素,并協(xié)調(diào)產(chǎn)品組合分析、風(fēng)險(xiǎn)管理和決策,負(fù)責(zé)會(huì)議議程的制定與會(huì)議紀(jì)要的撰寫,及時(shí)傳達(dá)行動(dòng)日志,推進(jìn)產(chǎn)品研發(fā)核心團(tuán)隊(duì)(GPT)的高效工作。 Conduct or contribute to periodic key program
review meetings (including, but not limited to Program Strategy meetings,
Program Risk Management meetings, Lessons Learned or Program Budget reviews) in
order to strive for earlier identification of critical success factors and to
facilitate portfolio analysis, risk-management and decision-making; prepare
meeting agendas and minutes and communicate action logs to improve the
efficiency of GTP.
5. 負(fù)責(zé)建立產(chǎn)品研發(fā)整體預(yù)算、研發(fā)進(jìn)度時(shí)間表的計(jì)劃、執(zhí)行與追蹤,負(fù)責(zé)跟進(jìn)項(xiàng)目的預(yù)算執(zhí)行與相關(guān)臨床試驗(yàn)的進(jìn)度,并負(fù)責(zé)調(diào)整優(yōu)化,保持與關(guān)鍵職能部門密切互動(dòng)與合作。并通過整合、優(yōu)化臨床研發(fā)資源配置,提出臨床運(yùn)營解決方案,最大化產(chǎn)品研發(fā)核心團(tuán)隊(duì)價(jià)值。 Establish the implementation and tracking plans
for project timeline and budget; accountable for ensuring the implementation of
program/projects budget and progress; be responsible of optimized budget
scenarios, maintain interaction partnership with key functions; propose the
optimal clinical operations solutions and promote and maximize team work value
through the integration and optimization of clinical development resource
allocation.
6. 負(fù)責(zé)準(zhǔn)備、更新和調(diào)整整體產(chǎn)品研發(fā)計(jì)劃的風(fēng)險(xiǎn)/機(jī)遇和解決方案,前瞻性識(shí)別和預(yù)測(cè)可能的臨床試驗(yàn)進(jìn)度延遲或影響臨床試驗(yàn)質(zhì)量的潛在問題,協(xié)調(diào)團(tuán)隊(duì)成員及時(shí),主動(dòng)地采取相應(yīng)措施,及時(shí)調(diào)整運(yùn)營計(jì)劃。 Be responsible for preparing, updating and
adjusting the holistic program risk/opportunity profile and mitigation plans;
and ensure proactively identify and anticipate potential problems that may
delay progress or affect project quality, and accountable for coordinating team
members to take timely and active measures and adapt operation plans.
7. 規(guī)劃和推動(dòng)產(chǎn)品研發(fā)核心團(tuán)隊(duì)(GPT)工作流程的建立,尋求GPT團(tuán)隊(duì)工作流程的持續(xù)優(yōu)化與改進(jìn),主動(dòng)獲得GPT成員的反饋。 Plan and drive establishment of workflow of GPT
and seek continuous optimization and improvement, actively obtain feedback from
GPT members.
8. 推動(dòng)制定GPT年度目標(biāo),團(tuán)隊(duì)管理目標(biāo),預(yù)算執(zhí)行目標(biāo),并監(jiān)督實(shí)施。 Drive development of annual GPT goals,
management goals at the team level and budget goals and supervise the
implementation.
教育背景:
1,臨床醫(yī)學(xué)或藥學(xué)、生物學(xué)等相關(guān)專業(yè)碩士以上學(xué)歷 Education: At least Master degree in relevant scientific
and/or medical, pharmacy, biology.
2,相關(guān)經(jīng)驗(yàn): 熟悉新藥臨床研究的運(yùn)作模式和流程、ICH-GCP等相關(guān)法律法規(guī);熟悉國際多中心臨床研究運(yùn)營模式;具有5年以上行業(yè)經(jīng)驗(yàn),具有3年以上全球臨床研發(fā)項(xiàng)目管理的經(jīng)驗(yàn)者優(yōu)先; Related Experience: Rich experience in operation
mode, workflow, ICH-GCP and other relevant regulations; Rich experience in
global clinical operation mode; 3+ years of relevant industry experience and 1+
year experience of global project management preferred; 3,語言要求: 優(yōu)秀的中英文口頭和書面溝通能力,能夠撰寫中英文項(xiàng)目進(jìn)展報(bào)告,能夠獨(dú)立主持中英文會(huì)議,能夠用流利的中/英文與海外臨床研發(fā)團(tuán)隊(duì)進(jìn)行溝通與交流 Language: Fluent in both oral and written English and
Mandarin, Independent writer of project progress reports and independent host
of meetings in Chinese and English, Good communication with overseas teams.
4,其他技能: 熟悉中英文辦公操作軟件環(huán)境;
Other Special:
Familiarity with computer software;
人力資源服務(wù)許可認(rèn)證
人力資源服務(wù)許可證是由國家人力資源與社會(huì)保障相關(guān)部門頒發(fā),代表人才經(jīng)紀(jì)人所在企業(yè)可以合法開展人力資源相關(guān)業(yè)務(wù)的資質(zhì)證件。展示該標(biāo)簽代表該企業(yè)發(fā)布此職位時(shí)已上傳《人力資源服務(wù)許可證》或《人力資源服務(wù)備案證書》并經(jīng)由平臺(tái)審驗(yàn)通過。
北京 - 昌平
杏林天賦(北京)人力資源服務(wù)有限公司北京 - 通州
北京悅康科創(chuàng)醫(yī)藥科技股份有限公司北京 - 西城
杏林天賦(北京)人力資源服務(wù)有限公司北京 - 海淀
鄭州葆春堂健康管理有限公司北京 - 大興
先通國際醫(yī)藥北京 - 朝陽
百利藥業(yè)