Description

ジェンマブは革新的な抗体医薬の開発に注力し、患者さんの生活を改善することに力を尽くしています。私たちは、extra[not]ordinary® な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。ジェンマブは思いやりがあり、率直で、患者さんに貢献したいという強い思いを持った人たちがともに働き、科学に基づく変化をもたらします。大胆さと高潔性を持って行動し、新しい未来をつくることを目指すことが、この使命を果たすために不可欠だと信じています。私たちは大きな志を掲げ、楽しく、そして思いやりの心を忘れずに、日々意義のある仕事に取り組んでいます。私たちは、個々のユニークな貢献を受け入れ、それらを原動力として、患者、ケアパートナー、ご家族、そして社員のニーズを満たす革新的なソリューションを生み出し、育み、維持するグローバルな企業文化の構築に努めています。私たちの想いに共鳴し、自分らしく活躍できそうだと感じたら、ぜひ一緒に働きましょう。Overview:The Sr. Manager, Japan Clinical Trial Manager (JCTM) is accountable for delivery of Japan and/or selected deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., eCRF, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development). Scope of responsibilities depending on number of patients/sites/size of trial. The Sr. Manager, JCTM is accountable for the end-to-end delivery of a single clinical trial from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Team (CTT) to deliver clinical trials including managing the trial budget if assigned to a trial as Global Clinical Trial Manager (GCTM). As Sr. Manager, JCTM, the employee represents Japan Development Operations (JDO) in one or more Japan Compound Teams (J-CoT) and contributes to the compound development strategy in Japan.Responsibilities/tasks as CTMTrial Planning and Oversight• Set target timeline, target number of patients, and required number of sites in Japan together with GCTM, JCoT members, CRO, and other related stakeholders• Review Task Orders with CROs for Japan• Involve in optimizing site costs in Japan as needed• Develop operational plans, manuals and charters for the trial• Review protocol and protocol amendments• Coordinate development of Trial Oversight Plan• Review Investigator's Brochure (IB) from DevOps perspective• Review Clinical Trial Application (CTA) submission package• Review Regulatory Green Light (RGL) packages in accordance with QDOC-08903• Review Development Safety Update Report (DSUR)• Develop Global Master ICF• Follow up on Trial Oversight identified findings during Oversight until closureSite Selection and Management• Drive site selection in collaboration with Start-up• Review and approve selected sites in Japan• Review/approve SSV summary• Coordinate review of CRO country-specific informed consent forms (ICFs) with internal stakeholders• Coordinate translation/back translation process of ICFs Vendor Management and Oversight• Oversee vendor management across vendors (does not include budget/change orders)• Approve key CRO staff e.g., Clinical leads, or Trial specific CRA (not including CRAs part of the partnership dedicated model which is managed via Oversight Manager)Trial Execution and Monitoring• Ensure achievement of key milestones (CTN submission, FPI, LPI, etc.) in Japan• Conduct initial Protocol Deviation (PD) assessments and track trends• Ensure the ongoing completeness of the electronic Trial Master File (eTMF)• Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date• Drive the ODB review meeting• Participate in RBQM activities (as implemented going forward)• Assist in maintenance of CTT issue log in collaboration with GCTM• Collaborate or manage study escalations both internal & external• Support GCTM to Assess KPI/KQI at the trial level• Support QA in site audit activities and potentially vendor audits (supporting with trial information and collection and providing of relevant trial documents)• Conduct booster visits• Participate in inspection readiness activities as assigned• Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial related items such as scans, blood samples etc.Responsibilities/tasks as GCTMTrial Leadership and Management:• Lead the Clinical Trial Team (CTT)• Lead the Trial Management (TM) team• Define and manage CTT goals (together with CTT)• Review and approve protocol and amendment changes• Review Master ICF• Approve operational plans, manuals and charters for the trial• Oversee vendor selection process• Initiate and ensure the accuracy and completeness of initial Work Order (WO) / Change Orders (CO)• Drive country selection process• Coordinate and respond to IEC/IRB comments• Overview of major PDs and PD trending• Approve data cleaning plans• Work closely with CPL as needed for CST/CDT• Ensure responsibility split is developed and maintained• Review and contribute to CSR as needed• Escalate issues to CPL in a timely manner• Execute operational strategy related to Drug supply• Execute regulatory submission strategy• Execute recruitment strategyBudget and Planning:• Assist in initial development and Manage trial budget• Plan, implement & ensure maintenance detailed integrated trial timelines from study outline though CSR (Gap: GCTM/CPL need a planner, e.g., MS Project, to show end to end project timelines and to build trust in organization)• Develop initial recruitment projections and strategy• Approve re-baseline recruitment projections in alignment with CPL• Act as counterpart for CRO PL/PM and approve CV of PL/PMRisk management:• Conduct study risks identification with CTT & risks management activities• Oversee CTT issue log and issue resolution• Oversee CTT Action/Decision logs are maintained• Assist in preparation for & responses to audits• Ensure CAPAs are in place, if applicableJapan specific responsibilities/tasks Drug Development in Japan: • Represent JDO in one or more J-CoT o Work with JCTM to ensure each study progress and milestone achievement in Japan o Ensure that departmental input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon operationalization of the trials o Proactively provide input on the development strategy of compound as a representative of JDO• Participate in preparation for and response to PMDA Inspection as a representative of JDO• Proactively join a cross functional activity including a process development/improvement• Collaborate with critical external stakeholders (e.g. CROs, vendors, experts) to drive long-term objectives across projects/programs, if applicable• Participate in external initiatives/task force teams such as EFPIA and JPMA and bring experience and knowledge to the relevant stakeholders, if applicable• Mentor other colleaguesThe Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.Competencies• Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence• Experience in leading & managing global teams• Experience in clinical drug development & ICH-GCP/J-GCP• Experience in trial management including budget and milestone management• Experience in mentoring CTMs and CTAs• Planning and budget management skills• Outsourcing and vendor management experience• Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed• Ability to foster a “One Team” spirit, inclusive mindset• Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset• Ability to think/behave or make decisions from the perspective of Management and/or Line Manager• Ability to align with Corporate, Dev Ops, Trial Management, and CDT goals• Excellent written and oral communication skills in both Japanese and English• Oncology experience strongly recommended場所ジェンマブは、可能な限り柔軟な働き方を取り入れることで、社員のワークライフバランスの向上に取り組んでいます。私たちのオフィスは、オープンな環境の中で従業員同士がつながることを目的としています。オフィスでも、リモートワークでも、お互いにつながることを大切にし、イノベーションを生み出します。 ジェンマブについてジェンマブは、革新的抗体医薬を通じて患者さんの生活を向上させることを目指す、グローバルバイオテクノロジー企業です。25年間、情熱的で革新的、そして協力的なチームが、次世代抗体技術プラットフォームを開発し、トランスレーショナルサイエンス、定量科学、データサイエンスを活用することで、独自のパイプラインを確立してきました。このパイプラインには、二重特異性T細胞エンゲージャー（bispecific T-cell engagers）、抗体薬物複合体（ADC）、次世代免疫チェックポイントモジュレーター、エフェクター機能強化抗体などが含まれています。ジェンマブのビジョンは、2030年までに、人々を感動させる抗体医薬品でがんやその他の深刻な病に苦しむ患者さんの生活を根本的に変えることです。ジェンマブは、1999年に設立されたデンマーク・コペンハーゲンに本社を構え、北米、ヨーロッパ、アジア太平洋地域に国際的な拠点を展開しています。ジェンマブでは、候補者個人データ及びプライバシーを重要なものと認識しており、個人情報の保護に関する法律その他の関係法令を遵守しています。個人情報の取扱いにご同意いただいた上、ご応募ください。詳細は、以下リンク先よりご確認ください：<a href="https://www.genmab.com/data-privacy/job-applicant-privacy-notice" target="_blank">Job Applicant Privacy Notice (genmab.com)</a>

Senior Manager, Japan Clinical Trial Manager

Description

Genmab