求人・転職情報
13件中の1〜13件を表示
外資製薬会社
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
<必須 / Mandatory>
People management
SFCE/SFE, sales planning role or consultant in healthcare sector
Decision analyst both qualitative and quantitative
Company-wide scale project lead
Proven track record of success in current position
■資格 / License:
<必須 / Mandatory>
Bachelor
<歓迎 / Nice to have>
MBA or equivalent strongly recommended
■能力 / Skill-set:
<必須 / Mandatory>
Business understanding including SFE-related strategy like Omnichannel sizing, S&T, Field incentive
Knowledge of Quotative analytical methodologies (e.g., regression analysis, Variance, STD)
Project management skills for company-wide scale projects
Negotiation and Stakeholder management skills for executive level business partners including global colleagues
Team management skills to manage diverse background colleagues
<歓迎 / Nice to have>
VBA, Python, SPSS, SQL, Power Automate
複数あり
1,400 万円 ~ 1,920 万円
外資スペシャリティファーマ
学士号以上(MBA尚可)
業界または関連分野で15年以上の経験
メディカルアフェアーズでの実務経験が10年以上
変化の激しい環境での成功実績があり、自律的に業務を遂行できる能力
成長機会や改善点、リスクを先読みできる能力
優れた口頭・書面コミュニケーション能力
外部ベンダー管理や明確な指示ができること
影響力と動機付けを発揮し、部門横断でのコンプライアンス遵守を促進できるリーダーシップ
■必須スキル
プログラムマネジメント
影響力のあるリーダーシップ
戦略的・論理的思考
変革マネジメント
高度なコミュニケーション能力(日本語・英語)
高い傾聴力
優れた問題解決能力
メディカルアフェアーズの深い知識
製薬業界の規制環境に関する知識
高い倫理観
結果志向
東京都
1,400 万円 ~ 2,000 万円
グラクソ・スミスクライン株式会社
This role leads Japan’s short- to long-term demand forecasting across the full GSK Japan portfolio (Medicine and Vaccines), translating business strategy into an aligned demand plan. Partner with Marketing, Finance and Supply teams to connect demand decisions to supply plans, protecting availability and healthy inventory.
【Why this role】
・Strategic commercial impact: influence growth decisions for Japan - GSK’s 2nd largest market after the US by turning brand strategy and market dynamics into the demand plan.
・Executive visibility: work closely with Business Unit Heads, partnering with Marketing and Finance to align assumptions and make decisions through monthly governance.
・Unique vantage point & growth: Japan is uniquely positioned under Supply Chain, giving you an end-to-end view from brand ambition to supply execution—while leading a team and building new forecasting capabilities with modern tools and methods.
【Key responsibilities】
・Develop and own the short- to long-term demand not only baseline forecast but upside and downside forecast for Japan, grounded in company strategy and market insight.
・Attend monthly cross-functional governance with Commercial and Finance to review, explain, and agree the forecast and key assumptions.
Provide expertise to drive launch excellence for key new products and manage lifecycle changes (pack changes, discontinuations, divestments).
・Support business development cases by building demand scenarios with limited information, applying structured assumptions and judgment.
・Provide Supply Chain expertise for business alliance / partnership initiatives, assessing feasibility, supply implications, and operational risks.
Translate the agreed demand plan into supply plans - communicating with domestic and global supply teams to secure supply continuity.
・Continuously improve forecast accuracy to support healthy inventory and service levels across the portfolio.
・Lead and develop the demand forecasting team, creating growth opportunities through coaching, new tools, and new forecasting approaches.
・Responsible for forecast submission into the system as key part of core commercial cycle.
■スキル Skills
・Relevant knowledge of marketing, finance or supply chain to maximize portfolio growth.
・Demonstrated strength in leadership and the development of a team
・Creating a performance culture and driving results, prioritization, execution, delivering performance.
・Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit.
・Experience communicating with and influencing/managing stakeholders up to Japan leadership team level.
・Experience in project implementation & a track record of successfully closing out these activities in a timely and efficient manner.
・Agile and distributed decision-making under pressure and with incomplete information using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox.
■経験 Experience
・10+ years of experience in supply chain, manufacturing, Sales, Marketing, or Finance
・Experience working with industry standards, trends, and expectations with ability to interact with and influence third parties.
・Experience modelling scenarios with multiple variables incorporating identification of key drivers, risks, financials, and sensitivity analysis.
・Experience with performance and capability in enabling and driving change, identifying, and implementing holistic business solutions.
■学位/資格/語学力 Education/Certification/Language
・Bachelor's degree (Preferably in Supply Chain, Finance, Logistics, Business, Economics, Math, Engineering) or practical experience in a relevant field
・Proficiency written and verbal communications skills in Japanese and English (Native-level Japanese, High business-level English)
【望ましい条件 Preferred Experience】
・Proven ability in Statistical forecasting, modeling, analysis and evaluation
・Understanding of the pharmaceutical industry
・Experience problem solving in Pharma/Biotech commercial
・Experienced in a matrix environment, able to drive impact across a range of functions
・Experience with SAP/ECC, APO or OMP
東京都
1,300 万円 ~ 1,810 万円
グラクソ・スミスクライン株式会社
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.
■Minimum Level of Education
・University degree or equivalent in an appropriate business / technical area (Engineering / Pharmacy / Business)
■Area of Specialization
・Industrial Engineering / Mechanical Engineering
・Lean / Six Sigma Certification
・Data Analytics
・Robotics & Automation
■Preferred Level of Education
・University degree in core function with master’s in business administration
・Lead / Six Sigma Certification
【Job-Related Experience】
・Minimum 3 years’ experience of managing functional or continuous improvement role with good learning agility.
・Understand manufacturing processes.
・Have experiences to work in or as part of Supply Chain.
・Has led multi stakeholders, cross-functional projects.
・Has worked in multiple departments/functions.
【Other Job-Related Skills/Background】
・Key talent of a functional role
・Good interpersonal skills
栃木県
1,200 万円 ~ 1,980 万円
グラクソ・スミスクライン株式会社
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.
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- Advanced degree in epidemiology, public health, biostatistics, or related field (Master’s minimum; doctoral preferred).
- At least 5 years of applied epidemiology experience, including work with real-world data or observational studies.
- Experience in pharmaceutical or healthcare industry, contributing to drug or vaccine development or post-marketing evidence.
- Strong skills in study design, protocol development, analytic planning and interpretation of observational research.
- Proven stakeholder management in matrix teams and working with cross-functional partners.
- Fluent in Japanese and proficient in English to operate in a global environment.
■Preferred Qualification
If you have the following characteristics, it would be a plus:
- Doctoral degree in epidemiology, public health or a related discipline.
- Experience with regulatory submissions and interactions with Japanese regulators.
-Experience in therapeutic areas relevant to Japan or Asia, such as infectious disease, vaccines, immunology or chronic disease.
- Familiarity with Japanese healthcare databases, claims, electronic medical records or disease registries.
- Track record of peer-reviewed publications or presentations at scientific meetings.
- Experience managing external vendors and multi-site collaborations in Japan and Asia.
東京都
1,000 万円 ~ 1,800 万円
グラクソ・スミスクライン株式会社
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.
• Master of Science or equivalent.
• MD, PhD, PharmD preferred
• Vaccine development experience in the Japan market preferred
• Considerable pharmaceutical industry experience is required
• Filing experience, JNDA as a core responsibility and have led development programs and deep experience in all phases of product development, especially in late phase development is preferred
• Experience of working with Japan regulators and regulatory requirements including an understanding of the legal and government frameworks
• High-business level Japanese and English
東京都
1,000 万円 ~ 1,800 万円
日本ベーリンガーインゲルハイム株式会社
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.
-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.
-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.
-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.
-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)
-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
・1+years’ experience at Experience at pharmaceutical industry at medicine department
・Experience in the field of clinical development is highly preferable
Job Impact
Conduct and Establish internal/external collaborations by sharing best practices
Minimum Education/Degree Requirements
Medical doctor
Experience as clinician
Required Capabilities (Skills, Experience, Competencies)
Knowledge and experience ・Substantial knowledge about local GVP/GPSP regulation and global GVP regulation.
・Knowledge and experience of preparation of periodic report/RMP/EPPV
・Knowledge and experience of performing signal monitoring
・Knowledge and experience of PJ management
・Experience on industry activities (e.g. participating working group across companies) (preferable)
・Excellent command of English language (toeic score more than 785)
Skill and Competencies
・Proactive and assertive attitude to establish team and networking
・Problem solving skill and crisis-management skills
・Analytical skills on industrial trend.
・Conceptual and strategic thinking
・Project management and decision-making skills
・Ability to mentor, coach and train others
・Proactive and assertive attitude with customer service orientation
・Excellent communication and presentation skills
Language skills:
• Japanese: Native
• English: Fluent
Required English speaking CEFR level : B2
東京都
1,000 万円 ~ 1,800 万円
ロシュ・ダイアグノスティックス株式会社
■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
【必須(MUST)】
■NGS(次世代シーケンサー)および関連するゲノム技術、業界に関する深い知識
※ライフサイエンス関連の修⼠、または博⼠号をお持ちであれば尚可
※臨床現場、またはアカデミア等での研究のバックボーンがあれば尚可
■NGS(次世代シーケンサー)の豊富な営業やアカウントマネジメント経験
■ビジネスレベルの英語⼒
※本国とのやり取り発⽣あり
■普通⾃動⾞免許
【歓迎(WANT)】
■代理店様との関係構築経験
東京都
1,000 万円 ~ 1,800 万円
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
4年制大学(理系学部)卒業以上(修士以上であることが望ましい)
<実務経験>
以下の業務の知識経験が10年程度以上
・化学合成品、バイオ医薬品及びコンビネーション医薬品の医薬品の研究開発、製造、試験に関わる知識経験
・医薬品開発及び承認申請業務及び市販後の変更管理に基づく薬事手続きの知識経験
・日本の規制当局との面談及び相談の実務経験
・国内外のステークホルダーとの良好な関係構築及びコミュニケーション
・組織運営/人材マネジメントの実務経験(5年以上の経験を持つことが望ましい)
<スキル・資格>
・医療用医薬品に関する規制要件・ガイダンス(ICH、薬機法、欧米の要件、等)に関する知識
・GMP(治験薬含む)に関わる業務経験を有することが望ましい
<語学>
ビジネスレベルの十分な日本語及び英語でのコミュニケーション能力(TOEIC 750点以上等)
<その他>
勤務地は大阪又は東京で、会社オフィスで5回/月以上の勤務が必要
求める人物像
1)新薬開発業務に熱意を持って取り組むことができる人間性
2)実務経験に裏打ちされた専門性
3)社内外の人間をまとめていけるリーダーシップ
4)規制当局や社内外Stakeholderとの交渉力
5) グローバル組織の一員として活躍する国際感覚
6)新しいことにチャレンジできる気概
7) 読み手に合わせた適切な文書作成力(日本語・英語)
複数あり
1,400 万円 ~ 2,000 万円
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
4年制大学(理系学部)卒業以上(修士以上であることが望ましい)
<実務経験>
以下の業務の知識経験が10年程度以上
・化学合成品、バイオ医薬品及びコンビネーション医薬品の医薬品の研究開発、製造、試験に関わる知識経験
・医薬品開発及び承認申請業務及び市販後の変更管理に基づく薬事手続きの知識経験
・日本の規制当局との面談及び相談の実務経験
・国内外のステークホルダーとの良好な関係構築及びコミュニケーション
・組織運営/人材マネジメントの実務経験(5年以上の経験を持つことが望ましい)
<スキル・資格>
・医療用医薬品に関する規制要件・ガイダンス(ICH、薬機法、欧米の要件、等)に関する知識
・GMP(治験薬含む)に関わる業務経験を有することが望ましい
<語学>
ビジネスレベルの十分な日本語及び英語でのコミュニケーション能力(TOEIC 750点以上等)
<その他>
勤務地は大阪又は東京で、会社オフィスで5回/月以上の勤務が必要
求める人物像
1)新薬開発業務に熱意を持って取り組むことができる人間性
2)実務経験に裏打ちされた専門性
3)社内外の人間をまとめていけるリーダーシップ
4)規制当局や社内外Stakeholderとの交渉力
5) グローバル組織の一員として活躍する国際感覚
6)新しいことにチャレンジできる気概
7) 読み手に合わせた適切な文書作成力(日本語・英語)
複数あり
1,400 万円 ~ 2,000 万円
株式会社Splink
当社の最大の強みは、予防から診断、治療後のサポートまでを一貫して設計し、患者様と医療現場双方にシームレスな体験を提供できる点にあります。
CTOはこの包括的なPatient Journeyを支える技術基盤の設計・開発を統括し、プロダクトのスケーラビリティ・セキュリティ・パフォーマンスを最適化することで、事業成長を加速させる重要な役割を担います。
医療知識は不問で、Webアプリやソフトウェア開発の経験があれば、技術的バックグラウンドを活かしてキャッチアップ可能です。
技術的な意思決定をリードし、エンジニア組織の強化を通じて、より高品質な医療体験の実現に貢献いただくポジションです。
■業務内容(雇入れ直後)
①技術戦略の策定と実行
事業目標に基づき、成長に対応可能な技術基盤を構築・改善。技術的負債の管理・解消を通じて、システムの拡張性とスケーラビリティを強化。
②アーキテクチャ設計と技術選定
将来的な事業成長を見据えたアーキテクチャ設計と、レガシーシステムのモダナイズを推進。データ統合と横断的活用により柔軟なシステムを実現。
③組織・チームマネジメント
エンジニアの採用・育成・評価を通じて、技術的意思決定の属人化を防ぎ、チームの自走化を促進。技術カルチャーの醸成にも貢献。
④経営・事業との連携
経営層と連携し、技術とビジネスの橋渡し役を担う。技術投資の優先順位を判断し、外部パートナーと協力して最新技術の導入を推進。
変更の範囲:会社の定める業務
■このポジションで実現できる未来
・医療の未来を支える技術基盤の構築:
予防から診断、治療後のサポートまで、患者体験全体を支える技術基盤の構築・改善を主導。医療業界に新たな技術標準を創出し、社会的意義の高い領域で技術リーダーとして活躍できるポジション。
・専門家との連携による成長機会:
Ph.D.保有者や医療機関のトップランナーなど、社内外の専門家と協働することで、先進的な医療技術に触れながら技術的視野を広げ、スキルを高められる希少な環境。
・裁量とスピード感のある技術戦略主導:
スタートアップならではの裁量と迅速な意思決定の中で、技術戦略の策定・実行をリード。市場ニーズを反映した技術選定や組織構築を通じて、事業成長に直接貢献できるダイナミックなポジション。
■経営と事業成長を支える役割
このポジションでは、経営チームの中核として技術戦略を通じて事業全体の成長に直接貢献します。
AI・データ解析・遠隔医療などの革新的技術を活用し、医療分野の変革をリード。技術基盤の構築だけでなく、投資判断・新規事業開発・パートナーシップ構築など、幅広い経営課題にも関与します。
技術と事業の両面から会社の成長を牽引し、認知症領域のヘルスケア市場における当社のビジョン実現を技術面から支える重要なポジションです。
・事業会社でエンジニアチームを牽引したご経験
・経営層との事業計画を策定したご経験
・エンジニア組織のマネジメント、評価制度の設計・運用のご経験
・TypeScriptを用いたWebアプリケーション開発の実務経験
【歓迎スキル】
■開発プロセス改善・生産性向上
CI/CD環境の構築、コード品質向上施策、技術ドキュメント整備、開発効率化ツールの導入経験。
■スタートアップ経験
CTO・技術責任者としての経験、シリーズA以降の技術戦略策定、ゼロイチ開発からグロースまでの組織スケール経験、限られたリソース下での技術的意思決定。
■クラウドインフラ・アーキテクチャ設計
GCP/AWS/Azureでの構築・運用、IaC導入、クラウドコスト最適化の経験。
■SNS連携・プロダクトグロース
LINEやFacebookなどのSNS連携機能開発、OAuth2.0/OpenID Connectによる認証設計、外部API/Webhook活用によるリアルタイム連携、SNSを活用した成長戦略の実行経験。
【求める人物像】
■周囲を巻き込むリーダーシップ
技術・事業の両面で主体的に課題を発見し、
関係者を巻き込みながら推進できる方。
■ユーザー視点と事業視点の両立
ユーザーのニーズを理解しつつ、
事業成長に貢献できるバランス感覚を持つ方。
■柔軟で前向きな課題解決力
不確実な状況でも柔軟に対応し、解決思考で物事を前に進められる方。
東京都
1,200 万円 ~ 1,800 万円
株式会社ヘンリー
【具体的な業務内容】
・シリーズC以降の資金調達における投資家コミュニケーション・交渉
・機関投資家・VCへのIR活動および投資家開拓
・事業計画・財務モデルの策定・アップデート
・バリュエーションロジックの構築・投資家向け資料作成
・IPO準備に向けた体制整備・証券会社との折衝
・M&A案件の検討・デューデリジェンス対応
・管理本部・経営企画チームとの連携によるコーポレート機能の強化
【ポジションの面白さ】
・代表と共に資金調達・IRの最前線に立ち、会社の成長を直接牽引できる
・シリーズC〜IPOフェーズという、スタートアップファイナンスの醍醐味を経験できる
・医療DXという社会的意義の高い領域で、ファイナンスを通じて業界変革に貢献できる
・経営陣・投資家・金融機関など、多様なステークホルダーとの折衝経験を積める
以下いずれかの経験3年以上
・投資銀行(IBD)でのM&A・ファイナンス業務経験
・事業会社での資金調達・IR・経営企画の実務経験
・財務モデリング・バリュエーション構築のスキル
・投資家・金融機関向けプレゼンテーション・交渉経験
・複雑な情報を整理し、ロジカルに伝えるコミュニケーション能力
【歓迎スキル】
・外資系投資銀行でのVP以上の経験
・スタートアップでのエクイティファイナンス・IPO準備経験
・プライベートエクイティファンドでの投資・バリューアップ経験
・総合コンサルでのビジネスデューデリジェンス経験
・MBA取得
・ヘルスケア・医療領域への知見
【こんな人と働きたい】
・自らディールを仕切り、最後までやり切れる実行力のある方
・投資家目線とオペレーション目線の両方を持てるバランス感覚のある方
・数字とストーリーの両面から事業の魅力を伝えられる方
・不確実な状況でも前向きに課題解決に取り組める方
・医療DXという社会課題の解決にコミットできる方
東京都
900 万円 ~ 1,800 万円
外資スペシャリティーファーマ(プライマリー・その他領域)
・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
・ラインマネジメント5年以上
・英語ビジネスレベル
東京都
1,500 万円 ~ 1,900 万円
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