求人・転職情報

Basic purpose of the job

Based on sound medical knowledge, this role defines the local Patient Safety & Pharmacovigilance (PSPV) strategy not aonly for the delegated asset (AT) but also other products as needed and ensures the consistent implementation of the BI risk mitigation strategy to safeguard patients and / or clinical trial subjects by providing benefit/risk (B/R) expertise to the cross-functional teams based on the framework provided by Global PSPV .
Together with the LPSL, the local Patient Safety Physician (PSP) ensures by contributing to the local PSPV strategy and by responsibly taking care of delegated parts of the local PSPV system to establish and maintain a high-quality local PSPV system which is compliant with external regulations and internal processes.

Accountabilities
As an expert of benefit/risk (B/R) profile, which are assessed by global BR team and aligned among global and local, engage to take safety assurance measures such as preparation of J-RMP, proper use of drugs and closely work with evidence/asset team by providing B/R knowledge and work with global team by inputting local needs/insight.
ž -Lead to prepare local Risk management Plans in response to Japanese specific requirements (e.g. country-specific format) and content in liaison with GPV functions.
ž -Implementation and progress of global risk minimization measures, lead to prepare local RMP development and implementation not only for the delegated asset (AT) but also other products as needed. Provide PV input and insights to local labelling documents and educational materials (e.g. SPC, PIL) in time and quality.
ž -Perform local safety data monitoring not only for the delegated asset (AT) but also other products as needed. Timely information of the respective PVWG Chairperson on any relevant new safety information received from local sources for BI products or for products of the same class.
ž -Promote implementation of safety assurance measure such as proper use of drug, including preparation of guidelines for them in collaboration with stakeholders (e.g.LRA, legal &complaince)
ž -Perform Medical Quality Review of all fatal / life-threatening cases as needed and defines appropriate follow-up measures. Complete ‘fatal case investigation’ report as needed.

Manage health authority requests, potential safety issues and / or crisis management not only for the delegated asset (AT) but also other products as needed and together with global/local stakeholders.

Contribute to the PSPV Culture, Local PSPV Strategy & the establishment and maintenance of a high-quality local PSPV system, Review controlled documents (e.g. PV Working Instruction, PV Repository, applicable sections in PSMF annexes, local SOPs, etc.) also contribute to Japan initiatives to promote Patient Safety & Pharmacovigilance concepts and conduct PV trainings, where the training needs were identified, for internal and external customers.

To be ready for inspection and support to management of non-compliance
-Reporting of non-compliances as soon as becomes aware of the issue and Contribute to investigate non-compliances and associated CAPA (Corrective and Preventive Actions) activities. Take over CAPA Lead Function, if required.
-Establish and support local inspection readiness, participate in PV audits and PV/GPSP/GCP inspections.

Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations

Proactively cooperation with Global PSPV on any upcoming new regulations or BI processes to assess the local impact and their implementation within the team.
-Contribute to seting up/optimizing of local PSPV processes including the takeover of subtasks e.g. creation/revision of the related documentation (Standard Operating Procedures (SOPs), Local PV System Framework, KMed Assets, etc.)

Regulatory and / or Organisational Requirements

Excellent knowledge of applicable global, regional and local PV regulations, BI processes and relevant GxP requirements.
Be compliant and acts within ethics at all times.

Job Complexity
The position requires extensive regulatory,scientific knowledge and balanced risk-based decision making. This needs to take into account needs and requirements of other functions, departments and units.

Interfaces
Local Medical Director, Global Patient Safety & Pharmacovigilance, MSG,CDMAs, LRA, MKT, SL, RWD
GRA, CD&O

職務内容

日本における医薬品（化学合成品、バイオ医薬品）の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者

・申請戦略・申請計画のCMCパートについて立案・遂行
・薬事関連の当局相談に係る戦略策定及び遂行
・製造販売承認申請業務（CMCパート）
・導入案件のCMC薬事関連の評価
・グループメンバーの教育訓練及び人財育成

Job Description
As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company’s vision/mission/value.

・Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
・Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discussions are anticipated.
・Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.
・Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.
・Lead a group of individuals to support group’s goals according to agreed timelines, standards and business priorities

職務内容

日本における医薬品（化学合成品、バイオ医薬品）の新規申請及び承認取得後のCMC薬事に関連する下記業務に責任を持つグループの責任者

・申請戦略・申請計画のCMCパートについて立案・遂行
・薬事関連の当局相談に係る戦略策定及び遂行
・製造販売承認申請業務（CMCパート）
・導入案件のCMC薬事関連の評価
・グループメンバーの教育訓練及び人財育成

Job Description
As a leader of Japan CMC & Devices RA New Drug Application group, lead the group to fulfill expected roles and responsibilities according to Global RA vision/mission and Company’s vision/mission/value.

・Oversee the development and execution of regulatory CMC development and registration strategies of all assigned products throughout clinical development and NDA approval.
・Successfully communicate and negotiate with Health Authorities as necessary, directly and indirectly, especially when difficult discussions are anticipated.
・Develop constructive relationships with and proactively escalate potentially critical issues to key internal and external stakeholders, including Alliance Partners.
・Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines and provide guidance to direct reports and all group members for their training and developments.
・Lead a group of individuals to support group’s goals according to agreed timelines, standards and business priorities

＜業務内容＞
■がんや免疫疾患、神経変性疾患といった複雑な疾患の解明おいて、次世代シーケンシングの需要は拡⼤
し、更に迅速かつ⾼精度な解析技術が求められてます。ロシュ・ダイアグノスティックスでは、2025 年
に画期的次世代シーケンシング技術「Sequencing by Expansion（以下 SBX）」を発表しました。
■従来の短鎖リード法では読み取り⻑や速度に制約がありましたが、SBX は DNA を物理的に拡張しなが
ら⻑鎖リードを⾼速で読み取るシーケンシング技術で⾰新的な速さを実現し、検体からゲノム解析まで数
⽇かかっていたプロセスをわずか数時間に短縮。加えて、従来の短鎖リード技術では解析が難しかった遺
伝⼦発現やメチル化パターン、空間解析を可能にしました。
◾ 2025 年 10 ⽉に⽶国ボストンで開催された⽶国⼈類遺伝学会（ASHG2025）において、Broad
Clinical Labs はこの技術を⽤いて「DNA サンプルから変異検出まで 4 時間以内」という記録を樹⽴し、
ギネス世界記録として認定されました。
◾この進歩はゲノム研究を⼤きく前進させるとともに、将来のトランスレーショナルリサーチや臨床応⽤
においてもその効果を発揮することが期待されます。
◾今回のポジションは業界に精通した次世代シークエンス顧客管理スペシャリストとして、シーケンス業
界変⾰の最前線に⽴ち、⾰新的な製品市場成功を推進頂く、アカウントマネージャー（管理職）の増員採
⽤です。
◾具体的な期待役割は以下の通りです。
・⽇本におけるシーケンス領域営業戦略や計画を策定し、収益と⽬標達成の実現。
・リード発掘と育成︓セールス機会を発⾒し、主要なステークホルダーと新規ビジネス関係を構築
・案件リードとして、マーケティング、製品管理、サービス、サポートチームと緊密に連携
・代理店様との関係構築と価格交渉

Job Purpose
GSKの製造拠点におけるGSK生産システム（GPS）の戦略策定と実行をリードし、サイト全体での品質・安全・コスト・デジタルイノベーション等の業務成績向上を推進します。サイト経営陣と強固な関係を築き、GPSの能力向上を通じて戦略展開を支援し、全階層・全機能での継続的改善（CI）マインドセットの定着を図ります。


1. Strategic Planning
今市サイトが年間プログラムを定義・明確化できるよう支援し、ブレークスルー目標や戦略的課題に照らして優先順位付けが適切に行われるよう促進します。
サイト経営陣（SLT）と連携し、継続的改善（CI）施策や活動のための適切なチャネルを構築して、正しい戦略と方向性にフォーカスさせます。

2. オペレーショナル・ビジネス
パフォーマンス管理システムを主導・展開し、目標達成あるいはそれ以上のパフォーマンスを維持するためのトラッキングとガバナンスを確立します。
戦略立案や問題解決の支援に向け、データ分析、自動化、デジタル技術を活用します。

3. コンプライアンスおよび手順実行
今市サイトのGPS成熟度目標に沿って、GPS基準が確実に組織に定着するよう実行・フォローします。

4. 人材マネジメントと能力開発
今市サイト全体で一貫したGPS能力を構築（例：パフォーマンス管理、リーンリーダーシップ、問題解決、ムダ排除 等）します。
今市サイト経営陣と協働し、優れたリーダーおよびチームの育成・定着を推進します。
自チーム内のチェンジプロジェクトを遂行し、他チームが自走できるよう支援します。
サイト全体で戦略展開がGPSおよびPSM目標と整合するよう、あらゆるレベルで人員を動員（プッシュ・プル）します。
個々のメンバーをエンパワーし、コーチングや指導を通じて各自が役割を全うし、持続可能な変革を実現できるよう導きます。


注記（略語）
GPS：GSK Production System（GSK生産システム）
SLT：Site Leadership Team（サイト経営陣）
PSM：Process Safety Management（プロセス安全管理）

■Job Purpose
Be accountable for leadership and development of site GPS (GSK Production System) strategy and implementation.  Build strong relationships across the site to deliver the business strategy and improve business performance (quality, safety, cost and digital innovation), GPS lead provide teaching and coaching to site leadership team to enable the site to deploy its strategy by building GPS capability to achieve maturity and a CI mindset across all levels and functions.

■Key Responsibilities
1. Strategic Planning
・Facilitate the site to define and articulate its annual programs.  Ensure the annual programmes are appropriately prioritized in line with breakthrough objectives and strategic imperatives. 
・Lead the site with the SLT to focus on the right strategy and direction by a channel for CI initiatives and activities. 

2. Operational Business
・Lead and deploy performance management systems, in order to track, on or above target performance.  Ensure appropriate governance and rigor in place. 
・Leverage Data Analytics, Automation and Digital technology to support strategy development and problem solving. 

3. Compliance and Procedural Implementations
・Ensure GPS standards are embedded as per site GPS Maturity targets.    

4. People Management & Development
・Build broad and consistent GPS capabilities throughout the site, from a strategic and operational perspective (e.g. performance management systems, lean leadership capability, problem solving capability, waste elimination capability, etc.) 
・In partnership with SLT, develop, drive and evolve the establishment of outstanding leaders and teams across the site. 
・Deliver change projects within own team and support others to do the same for themselves.
・Lead and mobilise (push and pull) across the site, at all levels, to ensure strategy deployment is prioritized and aligned to GPS and PSM goals.
・Empower, coach and guide individuals in order for them to fulfill their roles and deliver effective, sustainable change. 

■Position Summary
You will lead epidemiology initiatives in Japan to inform development and lifecycle decisions. You will partner across clinical, safety, regulatory and commercial teams. You will shape study design, manage external partnerships, and translate real-world evidence into clear recommendations. We value curiosity, collaboration, and a practical approach that balances scientific rigour with timely decision-making. Join us to grow your career while helping GSK unite science, technology and talent to get ahead of disease together.

■Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:- Lead design, delivery and interpretation of epidemiology studies and real-world evidence projects in Japan.- Provide clear epidemiologic input to cross-functional teams including clinical development, safety, regulatory and market access.- Manage external partnerships and vendors to access data, deliver studies and ensure quality and timelines.- Produce study documents and outputs: protocols, analysis plans, final reports, regulatory input and scientific communications.- Represent GSK in scientific and regulatory discussions in Japan and with external experts.- Mentor colleagues and contribute to knowledge sharing and process improvements across the Epidemiology team.

[Job Purpose]
The Japan Vaccine Development Lead (J-VDL) is accountable for a vaccine development in Japan to ensure delivery differentiated vaccines of value for patients, stakeholders and markets in Japan. The J-VDL serves as the asset level point-of-contact for Vaccine Development Leader (=VDL), and asset single point of contact to Japan senior management and Japan governance board. JVDL must work closely with VDL not only successful launch for Japan but also overall success for GSK Global as one of the key leaders in Global Vaccine Development Team (=VDT).
[Key Responsibilities]
• Provide leadership and collaborates with the central Vaccine Development Team (VDT) to create overall integrated development strategies that support optimal medicine development for Global as well as Japan, including Integrated Evidence Plan (IEP) and Vaccine Profile. Serves as the asset level point-of-contact for the central Vaccine Development Leader (VDL).
• Acts as a single point of accountability for all aspects of a vaccine development in Japan from initiation of Japan development to launch in Japan. Provide clinical leadership and asset/disease expertise for the clinical trial program and indications in scope
• Delivers differentiated vaccines 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.
• Provide Matrix Leadership in Japan (i.e. Japan Vaccine Development Team) to ensure integrated approach, robust planning, and execution oversight. Also supports differentiated development for team members; owns the performance of J-VDT and partners with line managers to drive performance. Serves as the single accountable decision maker to resolve disputes among the J-VDT.
• 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 between the J-EDL (accountable from C2CS to initiation of Japan development) to J-VDL (accountable from initiation of Japan development to the first approval in Japan) and from J-VDL to J-MAL/JCL (accountable after the first approval in Japan).
• 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.
• Responsible for making recommendations to TAL/IET Leader and senior stakeholders on benefit risk assessment, Go/No-go criteria, and Clinical PoS for the program in scope
• To create the communication strategy and represent GSK externally and keep good relationship with Regulatory and government organisations
• Ministry of Health, Labor, and Welfare, PMDA
• Japanese Government (Cabinet minister, Minister office)
• National Center, Researech Institute (National Cancer Hospital etc) Scientific Societies, EEs
• Patient Groups
• CRO（PPD）
• 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.
• J-VDL is accountable for delivering and managing the asset resourcing plan in Japan. In addition, the J-VDL is accountable for managing the asset budget in Japan.

■Mission
Design and operate Go-To-Market (GTM) model, optimizing the salesforce and multi-channel promotion structure. Your proposals will accelerate brand value delivery to customers and patients and directly drive business performance

■Key Deliverables
- Business impact: Shape resource allocation and execution from strategy to field operations, directly influencing revenue growth and market penetration
- Data-driven strategy: Leverage advanced analytics and AI to design personalized, evidence-based sales activities, from planning through monitoring
- Stakeholder influence: Partner with senior leaders, sales, and cross-functional brand teams to facilitate decisions and secure alignment

■Key Responsibilities
- Manage SFCE planning managers/associate and contribute as Insights & Business Excellent's Leadership team
- GTM model design: Define and optimize sales organization structure and the role of promotion channels
- Segmentation & targeting: Set customer, institution, and therapy-area priorities and actionable playbooks
- AI-driven activity planning: Provide personalized activity plans to sales reps using AI-driven insights and iterate for impact
- KPI target setting & monitoring: Establish goals, track performance, and drive continuous improvement (including dashboards and reviews)
- Field incentive design: Build transparent incentive rules, run simulations, and manage payout calculations
- Sales quota allocation: Set quotas, develop allocation logic, and oversee progress tracking
- Territory design: Design and maintain sales territories
Sales systems management: Administer territory settings, call planning, and related sales operations systems
- Cross-functional collaboration: Represent SFCE in cross functional brand teams
- Sales plan execution: Partner with sales managers and sales implementation teams to drive plan delivery

本ポジションは、Medical Affairsの戦略的最適化を担い、戦略、VPS（価値・エビデンス・アウトカム・出版・科学コミュニケーション）、メディカルエデュケーション、フィールドメディカルの4機能間の連携を促進します。業務効率と効果向上のための新基準やツールの開発・実装を支援し、タイムラインや予算管理を行います。業界動向を活用し、業務プロセスの改善提案や課題分析を実施、組織改善をリードします。グローバルとローカルの最適バランスを目指し、リソース管理やプロセス開発を推進。社内他部署と連携し一貫性あるメディカルアクションプランの策定を支援します。コミュニケーション計画の立案・管理や活動効果の指標設定と最適化も担当。クロスファンクショナルな課題解決をリードし、会社全体目標と医療施策の整合を図ります。交渉力や文化的感受性を活かし他部署と協働し、メディカルガバナンスの整備やコンプライアンス遵守を推進。メディカルアフェアーズの変革と高パフォーマンスチームの構築に重要な役割を果たし、社内外への情報発信を通じて貢献します。

・各ブランド・適応症の中心として、PVU/Franchiseのポートフォリオ戦略に基づき、商業・メディカル両面でのビジネス活動をリード
・部署横断でリソースプランを作成し、L&Dと協力してトレーニングプランを策定
・ソリューション、セールス、メディカルチームと連携し業務課題を特定、解決策を提案
・販売実績や事業進捗の月次分析をI2IやSOMと行い、定期的なビジネスレビューを主導