「Clinical Senior Director」的相似工作

1. 年度稽核計畫的訂定與執行，並提供改善建議、追蹤流程，確保內部控制制度持續有效 的實施。 2. 內控制度各項規章修訂及建議。 3. 規劃並推動執行年度內控自評作業。 4. 依法令規定完成公告申報事項。 5. 配合會計師及主管機關內控查核作業。 6. 主動查知內部流程相關問題，跨部門溝通協調、解決及優化各部門間之流程及作業，提 供專業管理建議。 7. 協助相關專案之推動及資料準備。 8. 其他主管交辦事項。

1. 管理與追蹤臨床受託研究機構(CRO/SMO…)公司、醫療機構之專案。 2. 管理與追蹤臨床專案執行品質、文件整理。 3. 落實臨床專案相關文件(計劃書、GCP…等)之設計、審閱與歸檔。 4. 協調臨床試驗相關事宜，加速臨床試驗進程。 5. 協助及配合臨床試驗監測與稽核。 6. 執行主管交辦其他事項。

- 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.

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. One of FORTUNE’s ‘Most Admired Companies’, we offer unparalleled scope for a career in world-leading clinical research. Global projects, innovative tools and industry leading customers combine with outstanding support and clear career management which allows you to make a difference and to connect with great opportunities. • Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations • identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.

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。

*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. 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.

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。

AIBEDA is a Contract Research Organisation (CRO) specialising in medtech and AI-powered healthtech innovation. The company provides end-to-end services, including regulatory strategy, clinical protocol design, technology assessment, and market entry support, to help clients navigate the global regulatory landscape. With a focus on agility, data-driven insights, and global connectivity, AIBEDA transforms complex regulatory challenges into commercial success. Are you passionate about clinical research? Are you excited about medtech breakthroughs impacting people’s health? If the answers are yes, we want to hear from you.

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.

Introduction to the job Do you like challenges and do you want to work in a fast pacing supply chain environment to support some of the biggest semiconductor companies worldwide? Are you familiar with Logistics Operations and like to managing urgent demands on a daily basis?  If this sounds like you and if you have a strong customer oriented mindset, here is your mission. Role and responsibilities For our Global Operations Center in Taiwan we are searching for Supply Chain Professionals. You fulfill the demand of our customers for spare parts and tools for their maintenance activities on some of the most complex machines in the right quantity and at the right time & cost. Time is of the essence to ensure a seamless production of our customers without interruptions on our machines. -Handling of urgent material requests from worldwide customers in a rolling 24/7 shift system with the right customer focus, while meeting all milestones related to communication and execution -Monitoring of worldwide shipments  -Ability to resolve complex issues and drive improvements to further optimize processes -Ability to support escalations and provide communication proposals for review -Constructive and reliable communication with worldwide stakeholders from all departments within ASML -This position requires shift work. Education and Experience Bachelor's Degree in related subject i.e. Supply Chain Management, Information Science, Engineering etc. preferred -Minimum 1 year of relevant experience in an international company, semiconductor industry is preferred -A tactical thinker with strong interpersonal and communication skills -Analytical thinking and ability to organize and prioritize workload Skills Working at the cutting edge of tech, you’ll always have new challenges and new problems to solve – and working together is the only way to do that. You won’t work in a silo. Instead, you’ll be part of a creative, dynamic work environment where you’ll collaborate with supportive colleagues.  There is always space for creative and unique points of view. You’ll have the flexibility and trust to choose how best to tackle tasks and solve problems. To thrive in this job, you’ll need the following skills: -Stress-resistant; act under high pressure -Flexible; willing to go the extra mile for the customer -Excellent professional communication in English, written and oral -Drive for results; does not stop until solution has been found, even when obstacles arise -Team player -Change management competencies -Convincing, pro-active and “can do” mentality -Cultural awareness -Experience with ERP system(s), SAP R/3 knowledge preferred -Ability to prioritize Diversity and inclusion ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that diversity and inclusion is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions.

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。

(合作廠商: 生華生物科技股份有限公司) 公司以臨床開發為主、基礎研究為輔，致力於小分子抗癌新藥的研發，專注在「市場首見(first in class)」抗癌新藥開發，在資金、營運、智財、藥物合成、藥物製劑、動物試驗及臨床試驗等等管理之經驗豐富，隨著臨床試驗由一期進入第二期及三期，以及開發新的適應症應用，整合完備的資源，能提供合宜的培訓需求。 JD職缺說明: 職稱: 臨床前研究實習 • 具有規劃、管理及執行臨床前試驗/或是臨床試驗之能力。 • 具備基本分子生物實驗技術。 • 了解如何設計良好及合適的動物試驗，以充分了解試驗藥物的潛在風險和益處。

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。

About this opportunity The Clinical Consultant is responsible for offering Treatment Planning Service (TPS) so as to guide doctors on ClinCheck treatment plan set up and explain about it with expertise. This role is to build Invisalign providers’ clinical confidence and competencies by demonstrating the clinical application through giving guidance and support to doctors’ own cases. In this role, you will… • Address any questions or concerns of the Customers related to the features and applicability of ClinCheck software and ClinCheck treatment plans as provided on the Invisalign Doctor Site (IDS). • Assist Customers with new functions related to ClinCheck including the latest ClinCheck software, and any other update or new release of the foregoing Invisalign treatment planning software from time to time and other associated services. • Assist Customers to assess case and provide guidance on case suitability. • Review and advise on ClinCheck plan to have a more predictable set up • Be a core member of projects for treatment planning, clinical support model projects or any other projects that require product or clinical input. • Engage and influence cross-functional teams to deliver an excellent clinical customer experience for all Invisalign providers. • Drive efficiency and effectiveness through all Clinical processes. • Participate in proactive team efforts to achieve departmental and company goals where applicable • Comply with all safety policies, practices and procedures. Report all unsafe activities to manager and/or Human Resources • Adhere to all company policies, procedures and business ethics codes and ensure that they are communicated and implemented within the team • Other duties as assigned from time to time In this role, you’ll need … • Graduate of Doctor of Dental University, Bachelor Dental school (Must have) • With Invisalign patient treatment planning and management at clinic or working in a corporate environment would be a plus. • At least 2 years of Invisalign patient treatment planning and management at clinic • Good technical knowledge and experience in dental • Experience in training dentists/orthodontists • Proficient in English • Effective communication and presentation skill • Regular business hours. Some outside hours in evenings and weekends, and travelling may be required from time to time

職責內容： 1.負責**細胞治療產品（含NK細胞、幹細胞與外泌體）**的新藥開發規劃、執行與監督 2.規劃並撰寫IND、Pre-IND、CMC等相關文件，與法規部門協作進行申報 3.與研發、製程、生產、QA/QC部門合作，確保新藥研發流程符合GMP/GTP與法規要求 4.協助設計並執行動物實驗與臨床試驗的研究計畫 5.與CRO、學研單位、臨床醫療機構等合作夥伴進行溝通協調 6.追蹤國際細胞治療新藥趨勢，提供公司技術布局與產品策略建議 任職資格： 1.碩士/博士學歷，生物醫學、藥學、細胞生物學、分子生物學、生技相關科系 2.至少2年以上細胞治療、再生醫療或新藥研發經驗（有申請IND經驗尤佳） 3.熟悉細胞治療法規要求（TFDA / FDA / ICH指引） 4.具備計畫管理能力與跨部門溝通協調能力 6.英文書寫與閱讀能力良好，能撰寫科學報告與申請文件

Pythia Biotech is a Taiwan-based startup dedicated to accelerating cancer drug development, immunotherapy, and precision medicine through Organ-on-a-Chip (OoC) technologies. We are expanding our team and seeking a Head of R&D to lead research, drive innovation, and advance translational applications. This is a rare opportunity to join a fast-growing startup, work alongside a world-class advisory team, and take on a pivotal leadership role as the company scales. Job Responsibilities •Develop and execute R&D strategies to support oncology and immunotherapy research. •Lead the development and validation of the TME-Chip platform. •Manage project timelines and resources to ensure successful delivery. •Support and communicate with partners to integrate resources and promote R&D progress. •Ensure that R&D complies with relevant laws, regulations and standards. •Prepare investment presentations, represent the company at academic and industry conferences to raise visibility. Qualifications •Ph.D. in Oncology, Immunology, Biomedical Engineering, Pharmacology, or a related field. •Minimum 2 years of experience in biotech or pharmaceutical R&D; prior leadership experience is a plus. •Familiarity with tumor biology, immuno-oncology, organoids, or Organ-on-a-Chip-related technologies. •Experience in cross-functional collaboration and project delivery in dynamic or startup environments. • Strong communication skills in both Mandarin and English; able to represent the company externally.

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 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。