「Clinical Senior Director」的相似工作

• Proactively manage project level operational aspects including management of trial timeline, budget, resources, and vendors. • Provide efficient updates on trial progress to the Clinical Director and/or Senior management team, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation. • Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets. • Ensure effective project plans are in place and operational for each trial and work proactively with the internal team/vendors to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements. • Ensure potential study risks are escalated to the attention of the Clinical Director when appropriate. • Chair internal working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner. • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner with internal team/CRO. • Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team. • Review and approve vendor invoices to ensure payments occur in a timely manner • Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements. • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the internal team/vendors regarding TMF filing, maintenance and archival procedure • Effectively provide support to CRO/internal team/vendors in the conduct of the trials • Support to development and review of SOPs and workflow

1.公司產官、產學計畫的申請與執行。 2.主導公司相關國際文獻的發表與蒐集。 3.提供科學性支持，與內部團隊或外部單位合作，積極參與外部醫學會議。 4.科學報告撰寫與文獻/市場報告分析整理，並參與專業會議與研討會。 5.協助公司進行海內外專業的科學臨床資訊。 6.完成主管交辦事項。

- Responsible for all aspects of site management and monitoring of clinical trials - Manage interactions with all partners (investigators, site teams, internal company departments, external contractors, etc.) to facilitate successful conduct of clinical projects. - Support clinical research activities as assigned by the supervisor. - Build strong professional relationships with investigators, site staffs and internal/ external service providers. - Conduct initiation visits, monitoring visits and site closure visits in collaboration with the clinical project team. - Maintain the Trial Master File. - Prepare and negotiate site clinical trial agreements and manage clinical site budget and expenses. - Preparation of regulatory and ethics submission dossiers. - Ensure protocol-related safety reporting compliance and address and drive issue resolution. - Monitor site recruitment and establish/discuss action plans in close collaboration with the Clinical Project Manager. - Develop and conduct training for investigators and site staffs in the protocol, product and study-specific procedures. - Coordinate activities to ensure compliance with protocol, GCP, overall clinical objectives as well as company policies and SOP. - Manage trial product inventory, shipment and storage, and ensure accountability and traceability. - Ensure that imaging and/ or laboratory samples are collected, handled and shipped according to protocol requirements. - Ensure that safety reporting of adverse events is completed within required time periods. - Manage external vendor services for assigned clinical sites. - Identify issues which affect clinical trial progress and quality, and develop solutions and/ or take action to resolve/ prevent them. - Deliver projects according to expected targets, budgets and quality standards. - Monitor and report to clinical management teams on clinical trial progress, performance and plan, including subject recruitment and retention, monitoring activities, data completeness and quality, and site compliance. - Assist in the organization and conduct of internal and external stakeholder meetings, as required. - Set up, maintain and update clinical research activities and initiatives in the system.

1. A M.S. or Ph.D. degree in Chemistry or Pharmacy with no less than two years of industry R&D experiences. 2. Strong background in analytical/medicinal/or organic chemistry. 3. Well-experienced in analytical method development and validation. 4. Hands-on experience in the development and characterization of intermediate of active pharmaceutical ingredient , formulation development and/or PK study analysis. 5. Excellent communication skills and good team spirit. 6.Looking for who is willing to take the challenge to be a pioneer combination chemist for novel drug discovery of CNS disorder.

*臨床試驗案件執行管理等相關工作 *規劃及執行臨床試驗專案計畫 *監督試驗過程與進度，試驗記錄，確實GCP標準程序 *完成相關主管醫療機構之審查 *相關PM工作經驗2年以上 *具大型醫學中心或醫院相關臨床實務經驗兩年以上 *有CRO公司2年以上經歷為佳

We are seeking a highly skilled Website & Digital Content Specialist to join our pharmaceutical company in Taiwan. This role will be responsible for managing, updating, and optimizing our global website content, ensuring accuracy, compliance, and timely execution of updates. The ideal candidate will have strong experience in biopharma or life sciences content management, excellent English proficiency, and the ability to serve as a key liaison with cross-functional teams, including our U.S. headquarters, medical/legal/regulatory (MLR) review boards, and brand planning committees. This position goes beyond execution: the selected candidate will also contribute strategic insights on how to improve website engagement, align digital content with brand strategy, and enhance our global online presence. <Key Responsibilities> 1.Website Content Management • Own the process of updating and maintaining company website content (corporate, product, medical education, and brand-related pages). • Ensure scientific and medical accuracy of all published content, with special attention to regulatory compliance. • Coordinate urgent or time-sensitive content updates, ensuring flawless execution under tight timelines. 2.Cross-Functional Collaboration • Act as the key owner and liaison for Medical-Legal-Regulatory (MLR) review processes, ensuring all digital content passes required approvals. • Work closely with U.S. and Asia-based teams, bridging time zones and cultural contexts to ensure seamless communication. • Participate in brand planning discussions, contributing recommendations on content strategy and alignment with brand goals. 3. Digital Strategy & Social Media • Support and enhance the company’s digital presence across owned media (website, social media, corporate communications). • Leverage social media management experience to recommend content strategies and community engagement initiatives. • Monitor digital content performance and propose optimization opportunities.

1. 可獨立與外部單位合作完成田間試驗。包含但不侷限於合作單位評估、相關文件準備、研究單位接洽、執行過程之溝通、結果分析、報告撰寫等。 2. 負責執行公司研發專案所需之毒理試驗、田間試驗所需之相關工作。包含自行執行及委外執行。 3. 負責執行案件中各文件(包含但不局限於試驗計畫書、ICF、CRF、案件送審相關文件)之撰寫、執行中紀錄、數據分析、及報告撰寫等工作。 4. 收集與了解國內田間試驗相關之市場法規需求。 5. 彙整專案執行成果，打造產品臨床開發策略。 6. 公司或組織經營相關之主管交辦事項。

【關於我們】 陽光燦亮診所是一家前瞻醫美中心，同步投資自有生技實驗平台，專注於高分子與天然衍生新材料的開發與轉譯。我們相信，最尖端的醫美成果來自「專業醫學 × 研發實力」零距離的不斷迭代推陳出新。 【為什麼加入我們】 1. 直觀見證成果-新材料從概念到臨床應用的週期大幅縮短，研發成果能快速在醫美產業創造價值。 2. 跨域學習資源-與皮膚科、整形外科醫師及生醫材料、組織工程專家協作，掌握市場第一手趨勢。 3. 完整研發鏈-內建細胞／組織培養室、材料分析儀與 GLP 級測試流程（規劃中），並同步專利佈局、學術發表與臨床試驗。 想把前沿生技材料化為可實踐、具體的醫美價值？ 這裡就是能讓你看見影響力的舞台。 【職務內容】 1. 生物技術的評估、測試、分析與選擇 2. 醫療器材及其製造技術的評估、測試、分析與選擇 3. 既有產品或技術的優化與製程導入 4. 細胞與動物實驗驗證 5. 制訂產品檢驗標準 6. 其他主管交辦事項 一起開發下一代醫美材料，創造真正改變肌膚與自信的解決方案。 立即投遞履歷，和陽光燦亮診所共創未來！

1.臨床試驗專案的主導、規劃、試驗進度追蹤管理、監督、回報及時程掌控。 2.管理臨床試驗相關費用與合約洽談、簽訂、付款、報帳、時程。 3.確保臨床試驗案符合GCP及相關各國法規。 4.領導跨部門團隊，協調與項目成員合作臨床試驗，案件執行管理等相關工作。 5.監督試驗過程與進度，確保所有步驟都符合GCP標準程序。 6.維護及協助臨床試驗相關文件記錄更新及管理，所有試驗文件檔案需整理並歸檔於部門內TMF。 7.其他臨床試驗相關之主管交辦事項。 8.文獻查閱及數據整理。

We are seeking a Clinical Operations Coordinator to oversee the planning and execution of clinical studies in compliance with GCP/ICH guidelines and company SOPs. This role serves as the primary contact for clinical trial operations and manages day-to-day activities to ensure successful study completion. 1.. Study Oversight & Compliance - Lead planning, execution, and management of clinical studies. - Ensure compliance with GCP/ICH guidelines, applicable regulations, and company SOPs. - Act as the primary point of contact for all clinical trial operational activities. 2.. Team Leadership & Coordination - Manage day-to-day activities of the clinical operations team. - Provide guidance and oversight to ensure timelines, budgets, resources, and quality standards are met. 3.. Cross-Functional Collaboration - Work closely with clinical project managers, medical monitors, pharmacokinetics, data management, regulatory affairs, and pharmacovigilance teams. - Ensure efficient and effective study conduct through cross-functional alignment. 4.. Stakeholder Communication - Communicate study progress to internal and external stakeholders. - Identify and mitigate study risks and issues proactively. 5.. Site & Vendor Management - Oversee investigational sites and third-party vendors to ensure high-quality execution. 6.. Documentation & Systems - Ensure clinical project-related documents and systems are developed and maintained to high standards.

1. 臨床試驗的規劃與執行，包括臨床試驗流程監控、Phase 1 臨床數據分析、Phase 1/2 & Phase 2 試驗設計所需之背景資料收集與解讀。 2. 規劃並推進 長效針劑產品 BE study，包含CRO選擇、資源配置與時程管控，確保與整體 研發計畫一致。 3. 進行臨床數據與 藥理/藥代（PK/PD）分析 之審查與解讀，並撰寫醫學與科學報告，以支 持法規申請與內部決策。 4. 協助安全性監測（SAE/AE 評估、signal detection）與真實世界/背景數據分析，確保受 試者保護與醫學合規性。

CRA for BE study/New drugs/Medical devices 1.Clinical research study setup/study procedure setup/site staff training 2.Site monitoring visits/source data verification/deviation reporting in compliance with GCP 3.Trial documents maintenance/regular site visits and maintenance/study materials supply/interim reports 4.regular report to sponsor/communication between sponsor and site. 5.site close-out/trial materials retrieval 6.audits/regulatory inspection participation upon request

1 與主管合作，定義專案範圍、目標、行銷、風險和可交付成果，以支持發展目標。 2 專案的主導、規劃、試驗進度追蹤管理、監督、回報及時程掌控。 3 進行專案所需的內部和/或外部資源整合，使專案在最有利隻狀況下進行。 4 制定專案預算，並管理專案相關費用。 5 確保專案各項工作的臨行符合相關各國法規規範。 6 領導跨部門團隊，協調與項目成員合作研究計畫、臨床試驗，案件執行管理等相關工作。 7 維護及協助試驗相關文件記錄更新及管理，所有試驗文件檔案需整理並歸檔。 8 其他主管交辦事項。

執行公司內部臨床試驗，您將作為 PMS (project management specialist)，根據專案的時程接觸到 CTA/SSU/CRA/RA相關事務 1. 管理及協調CRO、SMO、中央實驗室及研發團隊，特別針對細胞治療專案，追蹤試驗進度與技術需求，並必要時更新實驗室手冊，確保符合GTP及相關品質標準。 2. 負責臨床試驗計畫書變更之FDA及IRB送審，供應商合約簽署與費用管理。 3. 確保試驗藥品及細胞治療產品的供應與使用，必要時更新藥品手冊，並協助監控細胞治療產品的製備、運送及品質控管。 4. 追蹤試驗偏差與不良事件（AE/SAE），協助制定及執行矯正與預防措施（CAPA）。 5. 整理試驗資料與品質控管，確保數據完整並符合GCP、GTP及法規要求。 6. 與跨部門及試驗中心保持良好溝通協調，支持專案管理及問題解決，並配合細胞治療專案的特殊合規要求。

1. 抗體藥發現工作規劃、執行、與管理，具嚴謹邏輯與風險管控思考能力。 2. 分子細胞學分析實驗設計，建立與執行。 3. 抗體新藥發現、CMC\臨床開發或市場調查等工作，且具經驗者佳。 4. 需能快速查詢且閱讀國內外文獻，彙整思考後提出簡報，以解決目前面臨問題。 5. 其他主管交辦事項。

1. 執行動物實驗、細胞試驗與分生試驗 2. 執行藥物篩選與臨床前試驗(藥理、毒理) 3. 試驗方法整理與數據分析整理 4. 藥物開發相關參考文獻搜尋與整理

About the Role BeOne Medicines is seeking an enthusiastic and highly motivated Senior Research Investigator / Senior Scientist with expertise in gene engineering and genome analysis to join our Cell Therapy team. The successful candidate will play a key role in developing innovative genome engineering platforms to advance next-generation cell therapies. This role is responsible for leveraging the company’s proprietary technologies to design and deliver cutting-edge engineered cell products for clinical applications. Key Responsibilities • Design, execute, and optimize gene engineering strategies (e.g., targeted knock-in/knock-out, transgene integration, advanced editing technologies) in mammalian cells to meet project goals. • Independently derive, screen, and characterize engineered clones with strong hands-on execution, integrating molecular biology and genome analysis, while supporting routine lab maintenance to ensure efficient workflows. • Support NGS-based analyses (Illumina etc.) to evaluate desired modifications and genome stability. • Collaborate with bioinformatics, discovery, and development teams to deliver high-quality engineered cell therapy products. • Present scientific data and engage colleagues in technical discussions at internal project meetings. • Maintain a strong laboratory presence and contribute to an innovative, collaborative team environment. Qualifications Required: • PhD in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥3 years of relevant experience. (academic experience post-graduate also considered) • MS in Molecular Biology, Gene/Genome Engineering, Immunology, bioinformatics or related biological sciences with ≥5 years of relevant experience. • Proven hands-on experience with gene engineering technologies (e.g., CRISPR, viral vector, TALEN, mRNA delivery platforms) in mammalian cells (e.g., knock-in/out, transgene insertion, targeted modifications). • Strong molecular biology skills (e.g., cloning, PCR/qPCR/dPCR, Sanger sequencing, NGS analysis). • Knowledge or experience in developing and characterizing engineered cells. • Demonstrated ability to work in a dynamic, fast-paced environment with strong teamwork and problem-solving skills. • Excellent organizational and communication skills; proven ability to manage multiple projects under tight timelines. Preferred: • Experience with engineered cell therapy or gene therapy development (iPSC, MSC, T cells, NK, stem cell). • Familiarity with bioinformatics, pathway analysis, or NGS data interpretation. • Experience with advanced molecular biology techniques and flow cytometry. • Knowledge of genome analysis approaches for engineered cell therapy products.

細胞株開發是生物製藥產業的核心關鍵，直接影響後續藥物產量、品質與上市時程。本職務將加入我們的研發與開發團隊，負責哺乳動物細胞株（特別是 CHO 細胞）的建立、優化與工程設計，並參與從早期研究到 GMP 技術轉移的重要流程。這是一個能讓你結合專業技術與創新思維，推動新一代生物藥物平台發展的絕佳機會。 1) Cell Line Cultivation and Maintenance Perform hands-on cultivation, passaging, cryopreservation, and recovery of mammalian cell lines (CHO, HEK293, etc.). 2) Cell Line Screening and Workflow Optimization -Design and optimize cell line screening workflows to ensure timely and high-quality project delivery. -Experience with different types of CHO cell lines is welcome; not limited to any specific host type. 3) Cell Engineering and Genetic Modification (Preferred) Experience in CHO engineering is a strong plus, including practical application of CRISPR, transposon, or other genome editing tools for cell line development. 4) Cross-Functional Support and Laboratory Management 5) Assist in laboratory material and reagent management. Provide technical support across different functions and collaborate with R&D and process development teams. 6)Data Analysis and Presentation Effectively analyze experimental results and present findings through reports and presentations, with clear recommendations for improvements.

主要職務: 1. New project evaluation, perform literature study 2. Pharmacology and PK/PD data interpretation 3. Assist nonclinical & clinical CRO management 4. Project management for new drug development 詳細職務內容: 1. In-depth study on marketed drugs and their target indications, consider MOA, PK/PD profile, formulation design, brainstorming for new project ideas. 2. Various literature search and information gathering per supervisor’s request 3. Assist in nonclinical study design. 4. Assist in CRO contracting and follow up study execution. 5. Data processing & provide scientific interpretation. 6. Serve as PM role in various projects, taking meeting minutes, tracking development progress

1.學名藥與新藥臨床一期試驗設計、計畫書撰寫、藥物動力學數據運算、試驗報告撰寫 2.臨床前藥物動力學數據計算與分析，試驗報告撰寫 3.藥物學術文獻彙整評估 4.法規單位函詢與意見回覆 5.台灣/歐美臨床試驗法規 6.一年以上相關工作經驗優先