臨床開発部長

Job Overview Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies and practices. Clinical Project Management is focused on project delivery, productivity and quality resulting in strong financial performance and customer satisfaction. Clinical Project leads can run their own studies. The Project Lead focus is on leveraging therapeutic expertise and our suite of solutions to drive operational excellence and strategic leadership with our customers Essential Functions • Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies. • May be responsible for delivery and management of smaller, less complex, regional studies. • Develop integrated study management plans with the core project team. • Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures. • Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance. • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles. • Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally. • Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts. • Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans. • May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with our business development representatives, as necessary.; • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.; • Ensure the financial success of the project. • Forecast and identify opportunities to accelerate activities to bring revenue forward. • Identify changes in scope and manage change control process as necessary. • Identify lessons learned and implement best practices. • May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.; • Adopt corporate initiatives and changes and serve as a change advocate when necessary. • Provide input to line managers of their project team members’ performance relative to project tasks. • Support staff development and mentor less experienced project team members on assigned projects to support their professional development.;

ACCOUNTABILITIES This position will report to the Head of Global CSR and is responsible for the project management of Global CSR Program and supporting the effective execution and tracking of day-to-day duties of its ongoing projects. Responsibilities include: Lead and manage Global CSR Program project planning, work plan development and monitoring, and reporting to ensure effective communications between program partners, the Global CSR team, and involved internal stakeholders. Coordinate routine reporting and monitoring of Global CSR Program partners, track progress and reporting on results (including outcome data), manage payment process and donation usage reviews, help identify and mitigate risks, and help resolve conflicts and issues. Ensure that a result framework for managing results is in place and regularly tracked for each new Global CSR Program project by closely working with Global CSR Program partners. This includes how the project contributes to sustainable impact, by defining outcome and output indicators and establishing baselines at onset and tracking progress towards targets. Contribute to further development of a result framework towards tracking and demonstrating by data the effectiveness and impact of our Global CSR Program Support the day-to-day management of Global CSR’s Digital CSR Donation Management System, an online portal used to receive proposals and coordinate reporting and monitoring of ongoing projects. Develop contents to demonstrate Global CSR Program partners’ impact using data, and collaborate closely with corporate communications teams to help develop regular and ad hoc project communications for internal and external audiences. Lead coordination of employee participation programs, online and onsite, to create learning and engagement opportunities for employees and support other employee engagement activities as part of the team. Support to Global CSR Program Request for Proposal (RFP) process, including serving as a proposal reviewer, with particular attention on evaluating applicant and shortlisted proposal budgets, and supporting the proposal budget and narrative clarification process, due diligence process, and donation agreement completion and awarding process with internal partners and awardees (as needed). Contribute to the design and drafting of research findings, publications, project updates, tool kits, guidance documents, presentations, and reports, as needed. Assist in the development of project communications for leadership. Support the Head of Global CSR to pursue opportunities for collaboration with other internal teams, helping to build a cross-cutting approach to global health work. Support the Global CSR team with additional tasks as needed. We are seeking a highly motivated, results-oriented individual with strong problem solving and analytical skills to support the Global CSR Program. This role entails working with an entrepreneurial, self-motivated mind-set. The candidate must be able to function independently, be flexible, and have strong commitment to excellence. This will involve attending calls and meetings with leadership, tracking action items and requests, and developing technical materials as needed for meetings and presentations, partnering with others internally and externally to resource various activities and ensuring appropriate follow up. We strive for a strong team environment, working in tandem with internal stakeholders within the enterprise, from finance and legal to corporate communications teams to execute our Global CSR Program. The Manager is a critical member of Global CSR’s lean, agile and dynamic team. A successful candidate will have a background/ interest in global health and philanthropy, be proactive and detail oriented with exceptional organizational, problem-solving, decision-making, analytical and communication skills. This role will rely on strong skills in building collaborations, partnering with broad stakeholder groups, working across global projects and teams, result management, clear communication (verbal and written), and strong time and people management. This role will also require using and embracing of data and technology. A successful candidate will be required to develop strong relationships with a variety of stakeholders, internal and external partners, and effective interactions with senior audiences. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise We seek experienced professionals with a Bachelor’s degree and at least 5+ years of experience, preferably leading projects with expanding scopes of responsibility. Relevant work experience in roles focused on developing, implementing, and managing projects/programs. Broad understanding of global health/development issues and some global health/development experience is preferable. Experience in philanthropic grant management is a plus. Leadership Capable of influencing without ultimate decision-making authority, and gaining buy-in from various stakeholders to ensure successful implementation of programs. Able to understand all the shifting components of a project and what each entails while keeping the big picture front and center Demonstrated strength in structured problem solving, with the ability to easily identify and communicate frameworks to facilitate decision-making. Ability to work in a self-guided manner, and manage multiple priorities with demanding timelines. Ability to question and challenge colleagues including managers and partners in constructive manner. Accustomed to highly unstructured and ambiguous situations; ability to proactively resolve. Interaction Interacts with ease and appropriate discretion with key internal & external stakeholders (members and senior leaders in Global Corporate Affaurs, in other Business Units / Functions and senior representatives of non-government organizations, etc.) Innovation Demonstrated ability to think creatively to ensure successful management of results and completion of programs/ projects. Demonstrated ability to translate strategic and technical content from conversations into high-quality presentations and written communications in the framing and voice of a principal. Ability to think creatively to help organize information, manage workflow, and improve systems and processes. Ability to embrace data and technology Complexity An ability to execute efficiently across a wide variety of tasks and projects simultaneously. Excellent organizational, facilitation, oral, and written communication skills. Ability to work effectively and with sensitivity across barriers such as language, culture and distance. Excellent listening skills and compassion.

Line management of Clinical Research Associates (CRAs); Recruitment, initial and continued training and development of CRAs; Oversight and Management of CRAs to ensure CRAs are meeting expectations of core monitoring responsibilities; Tracking and management of CRA resourcing/allocation of assignment; and Manage turnover and retention of CRAs to meet company objectives

画像診断は客観的な臨床評価指標・バイオマーカーとして信頼性が高く、製薬メーカーが行う医薬品の臨床試験（治験）にも積極的に利用されつつあります。 画像解析事業部では、治験のエビデンスとして用いられることとなる医用画像にかかる一連の業務を行います。 【具体的には】 　・治験事前準備：撮像条件を統一する為、施設毎にファントム試験や調査を実施し、治験撮像手順書を作成。（施設毎に用意された手順書に則って治験時には撮像を行ってもらう） 　・画像ＱＣ：ワークステーションを使用して、規定された撮像条件が遵守されているか？一定の画質を維持できているか？の確認。 　・画像処理：ワークステーションを使用して、読影をスムーズに行うための画像処理。 　・画像解析：依頼者の要望に応えて、医用画像の新たな解析手法を提案・実施。 　・読影会（判定会）：判定医の先生に医用画像を用いて治療薬の効果を評価していただく会を運営。 【業務内容】 「応募資格」を満たす方は、特に以下の業務へも力を発揮していただくことを期待しております。 ・受託時に発生する画像解析方法の検討（コンサル～撮像方法、解析方法の検討） 【キャリアパス】 「薬効評価に医用画像を用いる」 上記のことを専門的に行っている企業は少なく、パイオニアとしての活躍が期待されます。 臨床開発の中のとりわけオンコロジー領域に特化したスペシャリストを目指していただけます。（医師や研究者との情報交換も多く、専門性を磨く機会は数多くあります） 【やりがい】 当社の画像解析事業部の受託は現状4～5割が抗がん剤の有効性評価に係るプロジェクトです。オンコロジー領域のご経験をお持ちであれば画像評価の専門医と一緒になって判定基準の設計や専門医へのトレーニング等に活かすことが出来ます。 先行他社がいない状況で、進む道を切り開いていく面白さがあります。