職位描述
崗位職責(zé)：1.作為產(chǎn)品研發(fā)核心團(tuán)隊(duì)（GPT）的成員，組織并推動團(tuán)隊(duì)對所負(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、中長期研發(fā)計(jì)劃，推動和指導(dǎo)研發(fā)策略的實(shí)施，對產(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、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)信息對內(nèi)和對外溝通，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)鍵會議（包括并不限于研發(fā)策略制定會議、風(fēng)險(xiǎn)管理會議，經(jīng)驗(yàn)教訓(xùn)討論或研發(fā)預(yù)算會議），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)會議議程的制定與會議紀(jì)要的撰寫，及時傳達(dá)行動日志，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，前瞻性識別和預(yù)測可能的臨床試驗(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，主動地采取相應(yīng)措施，及時調(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;
