■ 職務内容 / Job Description

Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

■休日：完全週休二日制, 年末年始

■ 職務内容 / Job Description

Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.

■休日：完全週休二日制, 年末年始

【R&D】Associate Director Site Management & Monitoring (ADSMM), R&D Development Operations, Late Development Oncology Clinical Operation 1

■ 職務内容 / Job Description
Ensure study deliveries with appropriate quality in terms of site management and monitoring part.
Responsible for developing staff(Senior Clinical Research Associate and Clinical Research Associate) capabilities to achieve high level of performance and productivity with the potential to lead and deliver studies in Japan.

• Ensure study deliveries within agreed timelines, cost/resources and appropriate quality in terms of site management & monitoring perspectives
• Contribute to continuous improvement activities, including study processes and other procedures
• Ensure effective clinical and operational feasibility assessments of sites level to execute study deliveries
• Ensure quality of selection of investigators, sites and SMOs (if needed)
• Ensure subject recruitment strategy including risk management of site management and monitoring areas is performed for every clinical trial and contingency plans are in place
• Ensure necessary actions are taken as a result of audits and regulatory inspections
• Ensure contribution for regulatory inspections of site management & monitoring areas
• Ensure the sharing of experiences and best/bad practices in activities related to managing sites and delivery of clinical trials from site management and monitoring perspective
• As a member of the Development Operations Leadership Team to contribute to the effective execution and implementation of the Japan Development Operations and R&D strategy
• Demonstrate accountability on the quality of deliverables from job holder’s function, by confirming the process and communicating with their staffs regularly and proactively to identify the issues and potential risks that may jeopardize the quality of the deliverables, and take necessary actions (e.g. review the contents, training of the staffs and solving process issues etc.) in timely manner
• Develop staff within the group to lead and deliver reliable, cost-effective and high quality clinical trial data, optimising processes from operational site level study feasibilities through to study closures
• Conduct Performance and Talent Management (in line with HR plans), in order to attract, develop and retain the best personnel (talent base)
• Compliance with AZ Procedural Documents, international and local guidelines such as ICH/GCP and J-GCP
• Perform regular co-monitoring/accompanied site visits in order to ensure staff skills and knowledge
• Model behaviours that foster AstraZeneca’s preferred work environment, including adherence to AZ Code of Conduct
• Plan and manage workload of staffs, ensuring appropriate supply of resources, including use of contract staffs
• FTE capacity planning and monitor and control workload of staffs in the group in accordance with appropriate SHE and Compliance standard

■休日：完全週休二日制, 年末年始

【Job Purpose】
The Japan Medicine Development Lead (J-MDL) is accountable for medicine development in Japan to ensure delivery of differentiated medicines of value for patients, stakeholders and markets in Japan. The J-MDL serves as the asset level point-of-contact for central MDL, and asset single point of contact to Japan senior management and Japan governance board.

■Key Responsibilities
・Acts as a single point of accountability for all aspects of a medicine development in Japan from initiation of Japan development to launch in Japan.
・Delivers differentiated medicines of value for patients, stakeholders and markets in Japan on time within budget, through an evidence package that supports regulatory approval, market access, and product life cycle in Japan.
・Leads the multi-disciplinary matrix team in Japan (i.e. Japan Medicine Development Team); supports differentiated development for team members; owns the performance of J-MDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-MDT.
・Collaborates with the central Medicine Development Team (MDT) to create strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Medicine Profile. Serves as the asset level point-of-contact for the central Medicine Development Leader (MDL).
・Works closely with the Japan Early Development Leader (J-EDL) as well as Japan Medical Lead (J-MAL) and Japan Commercial Lead (JCL) to ensure a smooth transition.
・Asset single point of contact and spokesperson to Japan senior management and Japan governance board (e.g. Portfolio Investment Board Japan).
・Proactively identifies unmet medical needs that could be addressed through line extensions in Japan.
・Prioritizes and maximizes the asset’s portfolio options including developing multiple indications in Japan.
Increases visibility amongst the external communities (physicians, regulators, patients, payers) in Japan, to bring medical solutions to patients with unmet medical needs, thereby enhancing reputation of GSK.
・Ensures quality & compliance oversight in line with R&D expectations and project needs; assures quality of data and science. Ensures excellence in execution of all governance processes, including oversight of all studies, pharmacovigilance, scientific engagement and promotional practices.
・Accountable for delivering and managing the asset resourcing plan in Japan. In addition, the JMDL is accountable for managing the asset budget in Japan.

■休日：完全週休二日制, 年末年始

■職務の目的：
臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。

■業務内容：
海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。

開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う
臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理
業務全般及び組織運営にかかわる以下の活動を担う。

各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成）

■休日：完全週休二日制, 年末年始

医薬品開発プロジェクトリーダー (PL) は，医薬品開発プロジェクトチームのリーダーとして，社内の関係部署，社外のパートナー企業やアカデミア/KOLと緊密に連携して，担当品目のグローバルにおける承認取得・育薬を目指した開発戦略の立案，これに基づいた開発計画の策定と実施，その進捗管理・統括を行う．そのために，開発品の特性を理解し関係する疾患領域の動向をふまえ求められるニーズに合致した製品開発推進に必要な開発戦略の立案を主導する．その過程で適応疾患の最適化や目指すべき製品特性の検証，更にはLCMを含む開発品の新たな付加価値創製を指向した非臨床/臨床試験計画を策定する．また，開発計画の実施状況の統括管理，スケジュールと予算管理を行い，開発プロジェクト全体の進捗を促し，開発品の価値を高めグローバルでの製造承認申請と上市の早期実現を達成する．
・開発品の特性・開発コンセプト・製品目標 (TPP：Target Product Profile) を策定し開発戦略へと反映させ開発計画に落とし込み，その実施と進捗に責任を担う．
・開発品の薬理作用メカニズムや対象とする疾患の特性に基づき，臨床において有効性の予測や患者の層別化に活用可能なマーカーの臨床試験への実装にチャレンジする．
・社内関係部署，社外の企業・アカデミアとのコラボレーションや規制当局との調整を円滑かつ効果的に進め，開発過程で発生した課題解決を図り開発品の価値最大化と開発の加速化を行う．
・導入評価，導出交渉，共同開発品におけるパートナーとの連携に際して企業の代表として対応する．
・プロジェクトチームの運営においてはプロジェクトの目標 (KPI/KSFなど) を策定し，それをチームメンバーに明示することで，チームの機能を品質，効率，有効性の点から最大化を図る．同時に進捗状況を定量的に分析評価し必要な改善措置を実施すると共に，業務遂行時に直面する様々な問題の分析と解決策を提案し実行する．

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

自社製品のMedical Plan及びTactics，予算を立案し，上級管理職から承認取得に責任を負う．この過程においては国内及び海外グループ会社，並びにアライアンス企業の関連部署との協力体制を取る．また，定期的にMedical Plan/Tacticsの進捗を管理し，課題解決をリードする．
メディカルアフェアーズ部にて立案される研究計画をレビューし，Brand PlanやMedical Planとの整合性や，研究シノプシスの妥当性を確認する．研究開始後は担当者による研究実行をサポートする．
担当領域/製品のPublicationについて，科学的インプットを行う．
メディカルアフェアーズ部における領域/製品の代表として，社内の研究開発，マーケティング等の部門との協同を行う．

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

国内外のTrial Master File (TMF) の管理を通じて臨床試験のQualityに責任を持つ
・TMF管理全般 (SOP/Manual管理含む）
・eTMF System仕様変更
・手順書，Specificationの作成
・TMF Qulity Review
・TMFに関するCRO Oversight
・信頼性調査準備/対応

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

自社製品/領域の責任者によるMedical Plan/Tactics，予算立案をサポートする．
自社製品の臨床研究の立案及び研究計画の立案に関与する．作成された研究計画に基づき，研究の実行体制を構築し，アカデミア/研究実施機関との折衝，外部委託先のコントロールを行い，研究を推進する．
製品/領域の責任者に対して，担当する研究の進捗報告を行う．課題がある場合には，解決案の提案と決定した課題解決案の実行を行う．

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

国内外の臨床試験のオペレーションをリードする
・臨床開発戦略，試験計画の立案
・CRO，Site，Vendorマネジメント
・KOLマネジメント
・各種手順書の作成
・試験の進捗/予算/タイムライン管理
・信頼性調査対応

※将来的に会社の定める業務へ変更となる場合があります

■休日：完全週休二日制, 土, 日, 祝日, GW, 年末年始

■ミッション
メビックスが受託する臨床研究案件のプロジェクトリーダーとして、プロジェクトマネジャー（主に上司）と連携して、プロジェクトチームの統括、医療機関やクライアントとの調整を行いながら、研究の推進を担当していただきます。
経験に応じてまずはCRAやサブリーダーから入って、ゆくゆくはプロジェクトリーダーをお任せしていく想定です。

■担当業務
・プロジェクトリーダーとしてのチーム統括、臨床研究の推進
・ 財団・研究会・KOL・クライアント企業(製薬会社)との折衝業務
・ 社内関連部門（データマネジメント・IT推進・営業担当等）との調整
・ プロジェクト進捗およびコスト管理、プロジェクトマネジャーへの定期レポート
・ 中期的計画に基づいたチームメンバー指導・教育

■休日：完全週休二日制, 年末年始

【職務内容詳細】
① 臨床試験の実施に際し、CRO、 ベンダー、試験実施施設を監督し、リスクを特定して運用上の問題を解決することで、試験の進捗をモニタリングする。
② 合意されたスケジュール、予算、および社内標準の品質で、試験実施施設の管理とモニタリングに関する全てのアクティビティを主導し管理する。
③ 施設選定／被験者募集戦略の立案及び実施する。
④ 問題をタイムリーに解決することにより、臨床試験データの質を確保する。
⑤ CROが試験実施施設の管理を実行するためのリスク軽減プランとコンティンジェンシープランの作成と管理を行う。
⑥ 信頼性保証部門と協力して、外部/内部監査に関連する活動をリードし、割り当てられたプロジェクトに関して規制当局の査察対応に貢献する。
⑦ すべての試験関連文書が最終保管されていること、そしてTMFが完成していることを保証する。
⑧ 試験実施計画書、同意説明文書作成への関与、日本語と英語間の翻訳を保証する。
⑨ 試験の管理に関する課題のエスカレーションを行なうとともに、課題解決に貢献する。
⑩ CROや中央検査機関等のビジネスパートナーとのコミュニケーションや交渉を行い、社内クロスファンクショナルチームやKOLとの調整を行う。
⑪ 臨床開発計画立案及び機構相談資料、試験総括報告書、CTD、照会事項回答作成に関与する。
⑫ 臨床開発業務関連SOPや様式の作成及びメンテナンスを行う。
⑬ その他、臨床開発部長のサポートを行う。

【社内外のコミュニケーション先】
（社内）研究開発本部、薬事・信頼性保証部、事業部、生産部
（社外）CRO、各種ベンダー、医療機関、PMDA

【想定されるキャリアパス】
・ 臨床開発部内のマネジメント職
・ 研究開発本部内外でのキャリア形成、マネジメント職

■休日：完全週休二日制, 年末年始

・医療機器の臨床評価業務に関わる組織運営／マネジメント業務
・GCP省令(Good Clinical Practice：医療機器の臨床試験の実施の基準に
　関する省令）に基づいた治験実施に関わる契約 および 外部提携先との
　アライアンス活動
・臨床研究／臨床開発の企画・計画立案・推進

■休日：週休二日制, 土, 日, 祝日, GW, 夏季休暇, 年末年始

【Job Description Summary】
Accountable for the oversight and coordination of program and study level (re-)feasibility assessments in the country, in collaboration with program and/or trial feasibility teams, in compliance with Novartis processes, GCP, ICH and regulatory requirements. This position is key to establish good communication and professional relationships with clinical investigators and company stakeholders on country/cluster/hub/global level Closely collaborates with Study & Site Operations and relevant medical/clinical functions to ensure successful allocation, realistic country targets, recruitment according to planned timelines, early identification of risks and opportunities as well as potential delays and mitigation plan.

【Job Description】
■Major Accountabilities
・Single point of contact for communication between Clinical Operations Program Managers / Clinical Operations Program Head, country/extended country group Study & Site teams and local relevant medical/clinical functions for all requests for program/study feasibility
・Coordinates the feasibility activities on country by ensuring:
・Site identification and selection, trial feasibility evaluation
・Collates/validates the list of potential sites by utilizing internal and external data (e.g. historical data, individual knowledge within local Study & Site Team and relevant medical/clinical functions, internal and external databases)
・Manages the study specific feasibility questionnaire and sends to all participating sites together with any supporting documentation, if applicable
・Follows up with sites to ensure questionnaires are answered and any additional feedback is obtained
・Assess the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment
・Enters feedback into global database if applicable (e.g. CLIP).
・Collects, analyses, and interprets data to provide comprehensive proposals and timelines for country allocation of clinical programs and assigned trials
・Responsible for early identification for potential risks and opportunities as well as potential synergies and back-up strategies within the country
・Closely collaborates with the Study & Site team to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development
clinical trials with the Study & Site Operations

■Key Performance Indicators
・Timely submission of feasibility data
・Performance against study commitments at the country level, including delivery of studies per defined number of patients and quality
・Delivery of study milestones esp. in startup phase in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

■休日：完全週休二日制

この役割は、日本における開発段階のプロジェクトにおいて、患者さんとその家族、科学や医療、そしてビジネスにとっての価値を最大化することに全責任を負 います。 担当プロジェクトの上市後は、開発部門の代表としてその製品に貢献し、主にコマーシャル部門及びメディカル部門と緊密な協働を行います。 また、この役割はプロジェクトチームをリードし、様々なコミュニケーションにおいてマネジメントや会議体、グローバル等に対してチームの代表として機能し ます。

Major Accountabilities
1. Provide the single point of contact on assigned projects/programs to stakeholders including Marketing, Sales and Global teams as a leader
2. Provide optimal recommendation on Japan development strategy to Global Program Team (GPT) and/or Global Brand Team (GBT)
3. Encourage and negotiate with GPT/GBT to integrate Japan program strategy into the Global Program/Brand strategy through a direct relationship with Global Program Head (GPH) or Global Program (Executive) Director (GP(E)D)
4. Optimize Project portfolio in assigned Therapeutic area ensuring Global alignment
5. Responsible for project management for assigned projects/programs. Consolidate, align and represent JPT’s position to GPT/GBT and vice versa
6. Set-up, drive and monitor assigned projects/programs by leading JPT and collaborating with GPT including adequate risk management adhering to compliance with international and local regulations
7. Coach JPT members and ensure that JPT members have the skills and capabilities to enable operational delivery of projects/programs
8. Quality accountability: Ensure adequate reporting of adverse events/technical complaint/compliance issue in accordance with company procedures and 100% timely delivery of all training requirements including compliance

ノバルティスには、様々な疾患領域において豊富パイプライン（約100の開発プロジェクト）と共に、"inspired/curious/unbosse d" に支えられている素晴らしい企業文化があり、社員一人一人がそれぞれに成長する機会を持つことができます。 ノバルティスには、世界中の様々な背景（国籍、言語、文化等）を持つ方が働いており、社員はそれぞれの仕事を通じて、世界中の社員と協働し、世界中の患者 さんに貢献することができます。

■休日：完全週休二日制

ノバルティスのプロセス、規制および倫理的要件に準拠し、薬物動態、バイオマーカー、安全性等に関わる生体試料の収集に関して、臨床試験へ実装し、臨床試験開始から終了までのOperationを担当します。また、コンパニオン診断に関連する業務についてもサポートする場合があります。

Responsible for the implementation and end-to-end operational execution of each GCO clinical trial strategy as it relates to all biospecimens collected, including safety, pharmacokinetics, biomarkers for clinical trials of standard to medium complexity, in compliance with Novartis processes and regulatory and ethical requirements. May support specific aspects related to companion diagnostics.
Job Description

■Major Accountabilities
> Lead Clinical Biospecimen Scientist(CBS)の監督下、社内関係者と協働し、戦略に基づき、臨床試験における生体試料に関する技術面・Operationに関連する業務を実行する。主に以下の業務を実施する。
​- 臨床試験関連文書（治験実施計画書や同意説明文書など）の臨床評価項目に情報を提供する。
- 臨床試験固有のサンプル収集表を作成する。また、ラボマニュアルなどの関連文書も含め、ラボキットの作成、サンプルの管理、検査会社（Laboratory）に対して技術的側面を管理する。
- 生体試料のライフサイクル全体を通じて、サンプル管理（処分含む）、輸送を担当する。社内関係者および検査解析会社（Laboratory）と協働し、症例報告書（CRF）とデータ転送に関する要件を定義し、 タイムリーな分析、転送されたデータの品質を担保する。
> Risk management: 社内関係者と協力し、生体試料の収集および分析に関連する臨床試験固有のリスクおよび問題を適切に報告する。
> Resource management: Lead CBSの監督の下、Vendor managerおよびProcurementと協力して、検査会社（Laboratory）からの提案、予算情報、および請求書の確認をおこなう。
> 担当臨床試験および担当プログラムにおいて、標準業務手順書（SOP）を遵守し、Lessen and Learnなどを通じて最良の結果を求める。

■Key Performance Indicators
> GCP, SOP, ICH等の遵守
> 社内関係者、および臨床試験チームからインプットをもらい、期限内にサンプル輸送ができる体制を整える 。
> 担当臨床試験において、効率的な代替案およびリスク軽減計画を含む業務計画を策定し、生体試料関連業務の適時、効率的かつ高品質で実行する。
> 設定された期限内に、臨床試験固有の文書の作成またはサポートをする。

■休日：完全週休二日制

■日本のプロジェクトチーム (JPT) のコアメンバーとしてプロジェクトチームを運営し，チームメンバーと共にプロジェクトの開発計画を立案し進捗を管理する仕事です。

■Job Purpose:
Partner with Japan Program Head (JPH) and Global Program (Executive) Director (GP(E)D) in Japan activities as a member of GPM to manage all aspects of assigned projects/programs within matrix structure by driving innovation, contribution to and execution of aligned strategies, ensuring regulatory approval, market access and reimbursement in Japan, and maximizing commercial value
• Lead assigned projects/programs by supporting JPH, and may deputize for JPH depending on priority and complexity of the projects/programs in Japan
• Grow in experiences and skills to be JPH and/or Line function managers

■Major Accountabilities:
• Accountable for all aspects of project and program management for assigned projects/programs in Japan
• Partner with JPH and Japan Program Team (JPT) members to drive development of program strategy and translation into realistic integrated development plan and ensure consistency of both program strategy and development plan with target product profile
• Partner with GP(E)D to align and manage the Japan project/program plan as a part of global development plan with Global Program Team (GPT) and to secure communication on Global development plan to ensure consistency of both program strategy and development plan between Global and Japan
• Coordinate and provide project information/data for the status and the value assessment to GPM, DU and Portfolio Management for reporting and portfolio analysis
• Accountable for high quality of JPT’s deliverables, such as JPT minutes, JPT objectives, strategic documents, such as tollgate presentations, and executive communication, input to key updates and portfolio review
• Ensure the quality and content of management communication, such as Monthly Update and JPT minutes
• Ensure alignment with other JPMs and JPTs to utilize same project management processes
• Ensure project forecast such as budget, timeline, milestones and sales forecast is developed with consistent quality and method across GPM-J
• Accountable to champion transparency in discussion and communication in JPTs
• May lead JPTs for non-high priority/complicated projects when delegated, under supervision by JPH
• Monitor progress of assigned projects/programs by communicating with JPT members locally and collaborating with GPD representatives globally
• Drive risk assessment and contingency planning by JPT
• Ensure integration of Global project management tools and processes in the day-to-day project team practice
• Support JPH to build high performing JPTs
• Leads or serves on process improvement, and/or contributes to GPM/DUs initiatives or other cross-functional activities
• Provides on-boarding, coaching, and/or mentoring support; develops and fosters GPM-J culture
• Quality accountability: Ensure adequate reporting of adverse events/technical complaint/compliance issue in accordance with company procedures and 100% timely delivery of all training requirements including compliance

■休日：完全週休二日制

■Job Purpose
Drive pipeline maximization for dedicated Development Units (DU) by providing portfolio analysis and supporting portfolio review for portfolio-related decisions. Contribute to strategic and efficient Japan drug development by providing portfolio insights, managing portfolio and project governance, the status and projection reports for pipeline and project resources

■Major Accountabilities：
I. Dedicated Development Unit(s) (DU(s)) per disease areas:
1. Lead portfolio review process in dedicated DUs in close collaboration with the DUs and
Franchise leadership team in Japan and global portfolio/pipeline team to maximize
pipeline value in alignment with franchise/disease area strategy in Japan
2. Monitor the dedicated DU pipeline value by portfolio analysis and provide the strategic
portfolio insights to the DU
3. Guide JPTs to prepare for strategic discussion and decision at Japan Development Point
(JDP) in portfolio/project governance (e.g. FLT-J/IDB-J, JPLT), which may include to
support business case analysis for specific projects/assets/disease areas
4. Ensure to capture and manage the pipeline/project information appropriately in
dedicated DU by building partnership with the DU (DUH/JPH) mainly, GPM and global
portfolio/pipeline functions
II. Portfolio/Pipeline level:
5. Provide regular status updates and projection on pipeline projects and project resources
to enhance productive execution
6. Manage portfolio and project governance platform/mechanism (e.g. JPLT Meeting/
Japan Development Point (JDP)) which enable to deliver quality alignment by sharing
the appropriate project information, priorities and portfolio status
7. Develop and manage efficient data processing and quality analysis/reports by utilizing
state-of-art methodology and technology in collaboration with global portfolio/pipeline
functions
8. Ensure to update the external pipeline disclosure with appropriate quality by managing
review process and to provide external surveys/benchmarking exercises
9. Make synergy with other members of Pipeline management team, lead collaboration
across functions and guide stakeholders to be better outcomes as a team
III. Others (Mandates in Novartis Japan):
10. Ensure adequate reporting of adverse events / technical complaint / compliance issue
in accordance with company procedures
11. 100% timely delivery of all training requirements including compliance

■休日：完全週休二日制

【Job Description Summary】
The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or multiple compounds. The JPCH closely works with Japan Project Head (JPH) as well as Global Program Clinical Head (GPCH) and inputs the risk benefit assessment for the program(s), and as the member of Global Clinical Team(s) (GCT) provides the inputs regarding the design, implementation, and execution of a clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view. The JPCH may contribute to disease area strategy.

■Job Description
１．Is an extended member of the GCT as representative of Clinical Development Japan (CD-J)
２．Is a member of JPT and drive the clinical development in Japan
３．Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD
４．Post-DDP, lead the development and execution of Japan clinical strategy. Provides Japan inputs to GPCH for developing an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful regulatory approval/market access for one or multiple treatment indications and/or multiple programs in Japan
５．Is responsible for Japan input to the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, Re-examination application dossier, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with CDP and TPP. Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, J-RMP, clinical benefit- risk assessment for license renewals) for the compound(s)
６．As the medical/scientific expert, contribute interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), Japan internal stakeholders (e.g., JPT, GDO/Trial management, Research, Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV), Health Economics & Outcomes Research, etc.), and internal decision boards lead clinical related health authority (HA) activities including development of briefing book and answers for questions from HA
７．Contribute to development of TA strategies (Rheumatology area)
８.　Provide on-boarding, coaching, and/or mentoring support; develop and foster Clinical Development culture
９. 　Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures
１０． 100% timely delivery of all training requirements including compliance

■Key Performance Indicators
The indicators below are applied for clinical related activities in Japan
Excellence in establishing clinical development and Re-examination strategy across various indications and programs with alignment across functions
Apply effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area
Robust evidence of quality medical/clinical review of trial data, development of CSRs
Support TA through high quality contributions to CDP and protocol reviews
Timely development of quality disease/program clinical standards, publications, and internal/external presentations
Timely delivery and submission of high-quality clinical program data in a cost-effective manner
External acceptance of clinical data and risk-benefit assessments by key decision makers including Health Authorities, pricing, and reimbursement bodies
Well contributed, effective, and engaged GCT(s) and GPT (as needed)
Clearly demonstrate Novartis Values and Behaviors

■休日：完全週休二日制

■プロジェクトの開始、メンテナンス、および終了までの全てのプロジェクトに関わる活動が計画通りに動くよう、関連各部署との調整及び管理
■Medpace Japanにおける担当試験の代表として、スポンサーと良好な関係を構築し（グローバルが窓口となる場合は、グローバルと密に連携し、グローバルを支援する）、適宜、情報共有、課題解決に向け協議
■Medpace Japanにおける担当試験の代表として、グローバルチームの関係者と良好な関係を構築し、適宜、情報共有、課題解決に向け協議
※グレードII以上のCTMには、ラインマネージャーとして部下の管理、指導、教育

Important duties and responsibilities associated with the job.
・Effective Management of a project including:
・ Coordinate and manage project start-up, project maintenance, and project close-out activities;
・Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
・Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;
・Serve as primary contact for protocol interpretations and logistical project-related issues (internal and external);
・Provide management oversight for Clinical Research Associates and Project Coordinators on project team;
・Interpret contract-related issues and coordinate Medpace activities according to current scope;
・Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;
・Communicate change in scope to Sponsor clinical team and Medpace Contract Manager.

Provide input for following (when applicable):
・Study protocol
・Edit Check Specifications
・Data Analysis Plan
・Data clean-up results
・Analysis
・Final study report

Contacts
Principle recurring contacts, including their frequency and purpose.
・Frequent contact with Sponsor, other contractors, and sites (external); and
・ Ongoing review of process and timelines for study progress with project team members and supervisor (internal).

Physical Demands and Working Conditions
Description of disagreeable conditions, physical activities, potential hazards, and travel associated with the job.
・The employee will be expected to travel for project-specific meetings.

■休日：完全週休二日制, 年末年始