漢康生技股份有限公司

1. Connect laboratory research with clinical practice, ensuring findings are relevant and applicable to real-world scenarios. 2. Develop and implement biomarker strategies and patient selection biomarkers. 3. Support early clinical PoC and development phases. 4. Collaborate with the clinical development team to design and execute appropriate phase 1/2a study(s) to generate FIH safety, PK, PD, and biomarkers to support continued clinical development. 5. Provide the clinical team with recommendations on drug indications based on drug mechanisms, preclinical research, and clinical trial results. 6. Build strong relationships with opinion leaders, scientific advisors, alliance partners, and patient advocacy groups to help drive the scientific communications program and to ensure that the team meets scientific and business objectives. 7. Lead and manage team members. 8. Perform other duties as assigned.

1. 和小組成員共同合作，負責執行抗體/蛋白藥物前端研發工作(包含但不限於抗原製備、抗體篩選、plasmids構建和抽取、細胞培養、體外功能實驗等工作) 2. 負責相關實驗操作與資料的紀錄，可獨立收集和數據分析，彙整結果撰寫實驗記錄與口頭報告，並能加以解讀實驗結果並解決問題 3. 協助SOP、實驗記錄及報告等體系的撰寫及管理 4. 負責實驗室相關儀器與環境的使用及維護 5. 協助主管完成各項交辦工作和任務

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. 協助以人工智慧工具實現對現行或未來各項目的分子設計。 2. 以人工智慧工具對R&D、PD/CMC數據、臨床數據進行資訊分析，並協助公司建立各種 相關資料庫。 3. 發展公司以人工智慧工具自行探尋分析Biomarker能力。 4. 依公司需求推薦或搜尋適用之人工智慧工具。 5. 開發並整合人工智慧使用在公司各個領域與部門。 6. 可獨立進行專案項目並達成專案目標。 7. 維護並管理分析實驗室相關儀器，協助SOP、實驗記錄及報告等檔案的撰寫及管理。 8. 完成主管交辦事項。

1. 協助以人工智慧工具實現對現行或未來各項目的分子設計。 2. 以人工智慧工具對R&D、PD/CMC數據、臨床數據進行資訊分析，並協助公司建立各種 相關資料庫。 3. 發展公司以人工智慧工具自行探尋分析Biomarker能力。 4. 依公司需求推薦或搜尋適用之人工智慧工具。 5. 開發並整合人工智慧使用在公司各個領域與部門。 6. 可獨立進行專案項目並達成專案目標。 7. 維護並管理分析實驗室相關儀器，協助SOP、實驗記錄及報告等檔案的撰寫及管理。 8. 完成主管交辦事項。

1.日常帳務處理; 2.配合會計師/券商/外部人等查核作業資料準備 ; 3.營業稅、各類扣繳調節申報及營所稅等各項稅務作業; 4.其他主管交辦事項; 其他加分 : 集團個體報表及合併報表編製。

- 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.

• 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. 與內外部團隊合作，執行公司專利的撰寫審閱、申請、答辯及維持等相關作業(專利年費 期程管控和通知)。 2. 專利檢索、可專利性分析、可自由實施(freedom-to-operate)分析、專利有效性分析、侵權鑑定、風險評估與迴避設計。 3. 專利技術與市場資訊收集與彙整；專案之盡職調查(due diligence) 4. 研究與分析相關智慧財產權之申請策略 5. 掌控專利申請進度，維護公司專利資產的有效性 6. 處理對外合作案所產生的專利或營業秘密 7. 提供IP相關培訓，使員工了解專利法律和程序 8. 專利各項技術支援、協助 9. 主管交辦事項。