職位描述
崗位職責：1.作為產(chǎn)品研發(fā)核心團隊（GPT）的成員，組織并推動團隊對所負責的創(chuàng)新藥產(chǎn)品制定臨床研發(fā)戰(zhàn)略與臨床試驗計劃，通過制定綜合性、跨職能的近期、中長期研發(fā)計劃，推動和指導研發(fā)策略的實施，對產(chǎn)品研發(fā)進行全過程、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.擔任負責產(chǎn)品的研發(fā)計劃和相關信息收集與溝通的關鍵聯(lián)系人，建立并維護產(chǎn)品核心研發(fā)團隊內(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.負責跟蹤在研產(chǎn)品多項臨床試驗的進度與狀態(tài)，同時確保不同報告系統(tǒng)中，產(chǎn)品研發(fā)信息的一致性、準確性和完整性，負責產(chǎn)品研發(fā)信息對內(nèi)和對外溝通，負責向管理層定期報告研發(fā)進展。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.負責定期組織和協(xié)調(diào)產(chǎn)品研發(fā)關鍵會議（包括并不限于研發(fā)策略制定會議、風險管理會議，經(jīng)驗教訓討論或研發(fā)預算會議），確定產(chǎn)品研發(fā)的關鍵成功因素，并協(xié)調(diào)產(chǎn)品組合分析、風險管理和決策，負責會議議程的制定與會議紀要的撰寫，及時傳達行動日志，推進產(chǎn)品研發(fā)核心團隊(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.負責建立產(chǎn)品研發(fā)整體預算、研發(fā)進度時間表的計劃、執(zhí)行與追蹤，負責跟進項目的預算執(zhí)行與相關臨床試驗的進度，并負責調(diào)整優(yōu)化，保持與關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，提出臨床運營解決方案，最大化產(chǎn)品研發(fā)核心團隊價值。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.負責準備、更新和調(diào)整整體產(chǎn)品研發(fā)計劃的風險/機遇和解決方案，前瞻性識別和預測可能的臨床試驗進度延遲或影響臨床試驗質(zhì)量的潛在問題，協(xié)調(diào)團隊成員及時，主動地采取相應措施，及時調(diào)整運營計劃。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)核心團隊（GPT）工作流程的建立，尋求GPT團隊工作流程的持續(xù)優(yōu)化與改進，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，團隊管理目標，預算執(zhí)行目標，并監(jiān)督實施。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)學或藥學、生物學等相關專業(yè)碩士以上學歷Education：At least Master degree in relevant scientific and/or medical, pharmacy, biology.2，相關經(jīng)驗：熟悉新藥臨床研究的運作模式和流程、ICH-GCP等相關法律法規(guī)；熟悉國際多中心臨床研究運營模式；具有5年以上行業(yè)經(jīng)驗，具有3年以上全球臨床研發(fā)項目管理的經(jīng)驗者優(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，能夠撰寫中英文項目進展報告，能夠獨立主持中英文會議，能夠用流利的中/英文與海外臨床研發(fā)團隊進行溝通與交流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;
