国際共同開発・当局対応の求人一覧

The Central Monitor plays a critical role contributing to the development, embedding, growth and health of the central monitoring capability in support of Risk Based Monitoring

仕事内容

< Position Summary / Objective >
The Central Monitor (CMN) plays a critical role contributing to the development, embedding, growth and health of the central monitoring capability in support of Risk Based Monitoring (RBM) methodology adopted The CMN is responsible for the remote assessment of Risk Indicators that identify issues and emerging risks in study-specific variables (trends / outliers / poor performing sites) through the review of aggregate data. Central monitors are responsible for the review of clinical and operational data. The CMN will interact with clinical teams and regionally based Site Monitors/Managers to support the oversight of the sites/studies as per the Risk Based Monitoring methodology adopted

< Position Responsibilities >
・ Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of programs and protocols.
・ Support execution of RBM processes as a part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).
・ Utilize analytics/visualizations to review aggregate data for the remote assessment of Risk Indicators that identify issues and emerging risks at the study, program, country, therapeutic and functional level, to ensure risks are addressed consistently.
・ Identify critical data issues and document findings for tracking and timely resolution.
・ Contribute to the development of or provide feedback on documented processes developed for risk based monitoring methodology being adopted .
・ Contribute to the development of or provide feedback on training material developed to support RBM methods.
・ Accountable for supporting global inspection readiness and inspections in regards to RBM monitoring process and tactics
・ Provide user input on IT needs necessary to support all aspects of RBM.
・ Contribute to the development and maintenance of metrics that inform the evaluation of central monitoring performance and effectiveness.
・ Accountable providing input on continuous improvement opportunities/initiatives within the GDMCM and GDO organization
・ Acts as a change agent with stakeholders across R&D, including educating, bridging knowledge across functions and developing effective partnerships with critical stakeholders.

応募条件

【必須事項】
< Experience Requirements >
3+ Years in drug development and/or,
3+ Years in the field of site management, site monitoring, data management or related.

・Demonstrated ability to effectively communicate ideas/concepts and to motivate others to accomplish challenging shared goals and objectives.
・Well-versed in analytical and conceptual capabilities
・Demonstrated ability to apply critical thinking and identify, distinguish relative importance and be able to work through issues remotely
・Demonstrated knowledge of clinical operations, inclusive of site monitoring, management and data management
・Demonstrated knowledge of Good Clinical Practices (GCP)
・ Demonstrated ability to absorb critical knowledge on relevant protocol/trial design requirements as well as relevant clinical/disease area knowledge
・Demonstrated ability to successfully manage competing priorities to achieve the goals of the department and the larger organization.
・Thorough knowledge of global regulatory and guideline (inclusive of ICH GCP) requirements with clinical experiences in a drug development capacity
・Demonstrated ability to build and maintain strong relationships across organizational and/or geographic boundaries through participation on cross-functional teams.
・ Basic office tools (e.g. MS Suite); tools (e.g. HRConnect, SuccessFactors Learning); Thorough knowledge of software and tools used for Central Monitoring activities (e.g. SAS and J-review reports; clinSIGHT; MS Excel); any new software identified to enhance the CMN role.
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

700万円～1050万円　経験により応相談

SMO管理やCRO CRAを主導および管理し臨床研究データを提供

仕事内容

・Manage a cross functional team of clinical experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality including documentations.
・Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).
・Oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.
・Lead and manage all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality.
・Plan and deliver a site selection strategy
Patient recruitment strategy including SMO managements
Lead and manage CRAs including CRO CRAs to deliver clinical study data
Develop and manage risk mitigation plans and contingency plans to execute site managements and monitoring from sites clarification to sites close on time.
・Manage the quality of clinical study data including queries and deviations and resolve issues as needed.
・Ensure the quality of monitoring visit reports focused on study specific contents.
・Lead activities associated with site audits in liaison with Clinical & Pharmacovigilance QA and contribute to regulatory inspection in the area of site management and monitoring
・Escalate issues related to site management and monitoring to an appropriate person and contribute to resolve.
Responsible for ensuring timely compliance by clinical delivery sub team with mandatory governance controls (such as Delegation of Authority, Study attestations, Letter of Assurance and Clinical Trial Disclosure).
Provide input and maintenance of up to date and appropriate quality, project and study plans (including timings and total costs) in agreed systems (such as IMPACT, OPAL and ACCORD).
・Lead a work package or manage a clinical study including scope, budget, timelines, risk management and communicate status (e.g. via generation of reports) and make a consultation with relevant function as required.
・Provide input along with the project team and functions the most efficient procedures to support delivery by taking the project situation and compliance requirements into account. This includes that ensuring sufficient appropriate training on processes, SOPs, standards and templates is provided to external partners.
・Ensure translation into Japanese of study documents such as CSP and MICF.
・Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
・Manage the study delivery related activities associated with regulatory inspections/audits in liaison with Quality Assurance and other relevant parties.
・May be assigned responsibility for project management and leadership of non-drug project work including applying lean sigma and change management techniques.

応募条件

【必須事項】
・University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
・At least 5 years’ experience from within the pharmaceutical industry or similar organization or academic experience.
・Extensive knowledge of clinical operations, project management tools and processes
Good experience of clinical development / drug development process in various phases of development and therapy areas
・Business English (Speaking level 7 or above, achieve common understanding at the context level)
【歓迎経験】
・腫瘍学の経験

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪、東京

年収・給与

550万円～950万円　

日本の研究開発における臨床業務のプロジェクト計画を主導する責任を担う

仕事内容

【Job Description】
Japan Associate Director Clinical Development (J-ADCD) is accountable/responsible for leading the project planning for clinical operation in Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/submission and post registration product maintenance phases and will include local and global working. The J-ADCD is responsible for planning, oversight on related studies and mediator among Japan study team, project team and Global project/clinical team. The J-ADCD is one of the key members of Japan project team to represent Clinical Operation arena and to contribute JPT deliverables.

応募条件

【必須事項】
・大卒以上
・Medical or biological science or discipline associated with clinical research
・At least 5 years’ experience in pharmaceutical industries or multinational healthcare organization.
Extensive knowledge of clinical operations, project management tools and processes
Proven experience of clinical development / drug development process in various phases of development and therapy areas.
Proven ability to learn by working in multiple phases, TAs and/or different　development situations.
Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).

・英語 English：Business English (Achieve common understanding at the context level with customers)
【歓迎経験】
・Working with external bodies, such as co-development companies and key opinion leaders, as a leading person.
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪、東京

年収・給与

600万円～1000万円　

プロジェクト計画と臨床プログラムの運用、およびプロジェクト管理業務を担っていただきます。

仕事内容

・Responsible for leading the project planning and operational delivery of Japan clinical work packages in CVRM TA, Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/submission and post registration product maintenance phases and will include local and global working.
・The role is to lead and manage defined clinical deliverables across a broad range of activities in Japan. This can include the responsibility to lead complex components of a clinical program such as Life Cycle Management, clinical submission activities, or indication development responsibilities or lead independent work packages or maintenance projects.
・Tasks involve project planning and operational delivery of clinical programs, and project management of the scope, schedule and budget. In addition to clinical work in drug projects, the J-ADCD may manage improvement or change projects in other business areas.
・The J-ADCD may be aligned to one or more projects depending on size and complexity.
・The J-ADCD may also cover Japan Clinical Delivery Manager concurrently to the clinical study which requires J-CDM contribution.

応募条件

【必須事項】
・製薬業界での10年以上の経験
・臨床開発、プロジェクト管理業務およびプロセスに関する幅広い知識
・開発、領域のさまざまな段階での臨床開発、医薬品開発プロセスの経験
・ビジネスレベルの英語力
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京、大阪

年収・給与

850万円～1200万円　経験により応相談

臨床開発戦略を生み出し、臨床開発オプションを設計

仕事内容

■ 職務内容 / Job Description

Clinical Scientist (CS) is accountable/responsible for the medical science expertiseto generateclinical development strategy, design clinical development options, and deliver successful clinical development of responsible products in Japan.

His/Her accountability/responsibility is mainly project-level, however, he/she is partially involvedin study-levelactivities, too, in order to achieve project-level delivery.

応募条件

【必須事項】
【経験 / Experience】

＜必須 / Mandatory＞
5 years or longer experience of working on drug development in pharmaceutical industry

【資格 / License】
＜必須 / Mandatory＞

Life Science related Bachelor degree required

【能力 / Skill-set】
＜必須 / Mandatory＞

Project management skill
Assertive communication skill
Strategic influencing skill
Conceptual Thinking
Negotiation skill
Logical thinking skill
Ability to work in a complex, business critical and high profile environment building credibility in ambiguous situations
Rapid adaptability to a new environment
Leadership capability
【語学 / Language】

＜必須 / Mandatory＞

英語 English：Business English


【歓迎経験】
Clinical science strategy planning in drug development
Negotiations with external experts
Planning of clinical science strategies as a Japan clinical science representative at the cross-functional team
Quality of knowledge on drug development strategy and clinical science
Experience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪、東京

年収・給与

600万円～1000万円　

ESR運用のマネージャーとしてプロジェクト管理を行う業務

仕事内容

■職務内容

Manager of ESR (Externaly Sponsored Research) operations is a leadership member of EOR (Evidence & Observational Research) and leading ESR operations team that includes Evidence Delivery Operation Specialist (EDOS), who has the ownership and accountability to ensure the effective delivery and management of entire ESRs planned and delivered in Japan

Accountabilities

・ Establish ESR operations organization and ensure the sufficient RWE/Project Management capabilities and capacity
・ Hold the ownership of the entire ESR operations and the accountability for delivering ESR contracts/amendments, tracking ESR progress (time/cost/quality), providing operational project management expertise to drive the effective ESR delivery as per the agreed evidence plans
・ Accountable for planning and controlling the entire evidence plans and budgets to support EOR　Director and TA (Therapeutic Area) heads, and managing the accurate inputs/updates to the business planning
・ Manage Contribution review, approval, contracting and payments including the management of relevant systems, tools and vendors
・ Establish collaborative relationships with Local R&D, Medical, Marketing, Regional teams, Other Marketing Companies and Global MEOR (Medical Evidence & Observational Research) to develop ’s approach to meet the evidence needs
・ Hold the shared-responsibility in developing organization strategy and capabilities

Manager of ESR operations will report to EOR director.

応募条件

【必須事項】
【経験】
＜必須＞
・ > 3years Clinical development experience as CRAs or equivalent and track record of successful study delivery
・ Successful line management experience OR track record in developing high performing people / team
・ Experience working with CROs for clinical studies

【資格】
＜必須＞
・ Bachelor or master degree in a scientific discipline

【能力】
＜必須＞
・ Leadership & Communication
・ Clinical Study Delivery
・ Project Management
・ External Service Provider (i.e. CROs) Management

【語学】
＜必須＞
・ Practical English communication skill /TOEIC > 800
・ Native Japanese

【その他】

＜必須＞
・ Cross-functional Stakeholder management skill

【歓迎経験】
・ Clinical Project Leader/Study Leader experience
・ Working both in R&D and Medical (>3 years each)
・ Line management experience
・ Working experience outside Japan
・ PhD in a scientific discipline or MD or MPH
・ Project management certification
・ Study Design, Statistics and Epidemiology
・ Medical writing & Scientific Publication
・ Demonstrated English communication skills in Global Team or outside Japan
・ Proven engagement capabilities ensuring broader business impacts across boundaries
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪

年収・給与

600万円～1000万円　

日本初のグローバルプロジェクトを管理する業務です。

仕事内容

当社の“日本主導のグローバル試験”において、
プロジェクトの進捗、品質、予算等を総合的に管理するグローバルプロジェクトマネージャーとして
日本発グローバルプロジェクトをマネージメントしていただきます。

■職務詳細
・スポンサーとの調整
・臨床開発プロジェクトのタイムラインの管理
・プロジェクトに関する提案、契約締結・社内(日本を含むアジア、ヨーロッパ、アメリカ)の調整・進捗管理
・プロジェクトの予算管理・調整

■メンバー構成
日本人はもちろん、ドイツ人・韓国人・台湾人が在籍しております。

応募条件

【必須事項】
・臨床開発におけるグローバルプロジェクトマネジメント経験者
・日本語：ビジネスレベル以上
・英語：ビジネスレベル以上

「臨床開発におけるグローバルプロジェクトマネジメント経験者」とは、グローバルプロジェクトのリーダー経験という意味ではなく、
複数国のリーダーをまとめているような方の事を指します。
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京・大阪

年収・給与

600万円～950万円　経験により応相談

カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担う

仕事内容

・海外本社カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担う
・試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする
・チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる
・試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う
・CRA（CRO含む）の相談窓口として、施設レベルの課題を解決する
・試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

【治験実施責任者】
・本社のカウンターパートと協力して、日本におけるエンドツーエンドの運用活動を主導する
・計画、開始、実行、完了を通じて日本のオペレーションチームを主導する
・メンバーとさまざまなベンダーを管理して、目標のタイムラインを維持する
・主要なマイルストーン、予算、および起こり得るリスクを管理する
・CRO-CRAの連絡窓口として調査サイトの問題に対処する
・研究の質と規制文書のコンプライアンスを確保

応募条件

【必須事項】
・製薬会社における臨床開発業務経験5年以上
・グローバル試験での複数の経験
・英語力（目安：TOEIC730点）（グローバル試験でのやり取りが可能なレベル）
【歓迎経験】
・オンコロジー領域でのプロジェクトマネジメント経験
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

550万円～1100万円　

トライアル管理の効率/生産性と品質の継続的な改善を確実にします。

仕事内容

Lead teams of Clinical Monitor Locals to ensure Japan country level Clinical Trial deliverables( quality, cost/resource, performances and timeliness)are successfully met;

With in-depth understanding of Japan and international regulations / guidelines / policies related to clinical trials, ensure implementation of BI SOPs/policies /systems for clinical trial management within COJ; ensure continuous improvement of efficiency / productivity and quality for trial management; Maintain strong network both within BI and in the Industry in Japan

Ensure proper trial planning in Japan by actively support and contribute to strategy feasibility, patient centric activities; TA discussions when required.

Hire and identify dynamic, competent talents to ensure proper resourcing of CMLs within COJ; establish a learning environment for talent development to ensure continuous talent pipeline for trial management

As a member of COJ leadership team, actively contribute to COJ initiatives; liaise with other functional leads to establish a collaborative, learning culture within COJ; when assigned, act as a representative of COJ for global projects / intiatives

Accountabilities

Ensure Clinical trials allocated to Japan are properly managed and trial deliverables are met:

・from trial planning to trial closure
・including quality, timeline, performance, cost and resources
・lead strategy for inspection related to trial management, including sponsor oversight responsibilities
・Ensure trial related training are provided to both internal and external trial team members
・ensure timely resolution of issues related to trials
・liaise with site monitoring function for proper trial oversight
・liaise with CDMA for external expert engagement in Japan

Liaise with relevant functions within COJ, to ensure implementation of BI trial management processes/systems and QMS:

・ensure CML team, and relevant parties are trained on BI trial management processes / systems
・Align COJ processes / systems with BI global systems / processes for minimum repetition to optimize efficiency and productivity, liaise with global process owner if required
・ routinely analyze data to identify areas for improvement of quality, efficiency and quality
・ be the escalation point of trial management related issues; ensure resolution of issues

Proper trial planning in Japan:
・ actively support and contribute to feasibility and patient centric activities
・participate in TA discussions when required
・proper planning of trial by conducting appropriate country allocation feasibility to optimize the site potential for efficiency and productivity

As a member of COJ leadership team, actively lead and contribute to initiatives to achieve COJ vision:
・identify areas for improvement of quality, efficiency productivity
・be innovative
・apply new technology
・establish collaborative, learning culture
・actively promote COJ within NBI and BI global

Development of trial management team:
・identify and hire both internal and external competent potentials for development in the area of country study management
・Liaise with TCM team lead, and Head COJ to identify potentials from CSM group to be developed as TCM; or other function areas within COJ, or NBI medicine; ensure implementation of development plan
・Liaise with head clinical site monitoring to identify potentials from site monitoring group to be developed as CML, and support the implementation of development plan

応募条件

【必須事項】
・大卒以上
・臨床医薬品開発、臨床業務に関する幅広い知識（10年以上）
・臨床開発におけるリーダーシップの経験
・臨床開発、人的管理、予算に関する知識、規制要件の十分な理解のある方
・ビジネスレベルの英語力
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

700万円～1200万円　経験により応相談

臨床試験に関連する活動のためのSOPとシステムの適切な実装を保証

仕事内容

Basic purpose of the job

Accountable for the operational management of Japan component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.

Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management on country-level.

Ensure proper implementation of SOPs and systems for clinical trial related activities; contribute to continuous improvement within COJ for quality, efficiency and productivity.


Accountabilities

Leads Japan trial team in the capacity of Clinical Trial Manager (CTM)

Trial Preparation, Conduct and Closeout:
1. Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP, Japan-GCP and all other relevant external regulations.

2. Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals.

3. All Regulatory Requirements are satisfied prior to trial/site initiation.

4. Where necessary, set up and manage external suppliers that meet requirements of Japan trial operations.

5. Set up, manage and review Japan trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.

6. Ensure appropriate trial-specific training of Japan internal and external partners in line with Trial Training Plan

7. Monitor trial quality in collaboration with Site Monitoring Lead and CRAs, ensure
- provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, SOPs (for staff and issue), and adherence to trial protocol.
- adequate trial supply distribution to sites.
- continuous and timely data entry and cleaning, and on time Data Base Lock.
- Ensure trial is inspection ready at any time.
- Ensures timely update of CTMS

8. Trial contact for CRAs, investigators and site staff.

9. In collaboration with Local Trial Record Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices and .

10. Oversees corrective actions and preventive actions (CAPA) and follows up actions on issue management on aasigned trial. Act as CAPA lead if assigned.


Management and Relationship Responsibilities:

Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level, and supporting CRAs in site contacts.

Collaborates with other functions to support Trial Management topics and and support integration across Medicine.

Participate in working groups related to Trial Management, represent trial on local and regional country level, providing updates on trial within Japan.



Issue escalations and management:
Manage and escalate identified issues to stakeholders appropriately and work with stakeholders (e.g. team members and COJ management) to solve issues in a timely manner.


Contributions to project and trial strategy :
1. Support CDP input from Japan where CTM is assigned as a COJ representative. i)Work with related working groups, COJ management team and actively contribute and support early input to CDP from COJ perspective
ii). Align with relevant medicine functions in Japan to ensure proper communication on CDP-related topics from CO aspects, including but not limited to, Japan integration strategy, trial design/timeline/budget for Japan, engagement of potential investigators in Japan.

2. May contribute to the collection of data for Project and Trial Feasibility that define key aspects of a CTP.



Promote continuous improvement and learning culture:
1. Takes initiatives for continuous improvement of quality, efficiency and productivity in COJ to achieve Our Vision and priorities.
2. Contribution to build a learning culture within COJ for shared learning


Regulatory and / or Organisational Requirements

Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices and regulatory requirements. Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Values.



Job Complexity

Leads local trial team to ensure integrity of trial conduct, assurance of patient safety, and that local/regional component of trial is planned, conducted and reported in line with regulatory requirements. Requires orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.

Works within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites. Represents the company for the function at internal and external meetings, e.g. with investigational sites or regulatory agencies/inspectors. Failure can have impact on project deliverables (e.g. timelines, costs, integrity of trial data), the reputation of BI with stakeholders and regulatory agencies. More than one assignment in parallel requires balancing conflicting priorities. Is involved in design and implementation of new innovative method as working group member.


Functional leadership role within a clinical trial and within responsible country /region with no direct reports.

Lead and/or project manage local/regional trial team members and colleagues including but not limited to: CRAs, Project Assistants, Local TMF Records Specialists, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Quality Medicine, local/internal Patient Advocacy Team.

Liases and partners with global trial team members including but not limited to: CT Leader, Site Monitoring Lead, Medical Monitor, Trial Data Managers, Pharmacovigilance, Clinical Trials Supplies Unit, Strategic Sourcing, TMM.

Provides oversight and relationship management with external partners including but not limited to: Investigators, Study Coordinators, Central Ethics Committees, Hospital Pharmacists, Research Networks, Local Suppliers

Within Japan, other functions within COJ, and other functions within Medicine or Marketing as appropriate



Job Expertise

Solid-level knowledge in clinical trial management including site activities in Japan.

Solid communication, project management, networking/stakeholder management and team leadership capability. Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements

応募条件

【必須事項】
Job Impact

BI sponsored trials conducted according to applicable regulations and BI SOPs/procedures to safeguard patient safety / wellbeing, and data integrity;
CT Manager’s oversight allows for
- delivery of trial commitments, including quality,timeline and budget;
- delivery of successful trial data towards provision of safe and efficacious medications.



Minimum Education/Degree Requirements

University degree in life sciences or related field, higher degree/qualification preferred (e.g. MSc, PhD).



Required Capabilities (Skills, Experience, Competencies)

Strong communication skills in complex cross-functional matrix structures. Enforce AAI approach and skills in the trial team and trial management. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Highly developed receptive communication skills, cultural sensitivity
Challenge the status qua of the site management enviroment in Japan and assumptions of your own and others, with no political bias
Technical Expertise: Demonstrates knowledge across all aspects of clinical trial operations and execution including risk management, vendor oversight on country-level, issue management, communication plan, budget/resource management. Knowledge in a relevant Therapeutic Area is an asset. Dimensions of trial complexity for this project management role include protocol, trial subjects, sites, countries, suppliers. Ability to work across several studies and in different Therapeutic Areas.

Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.

Strategic Mindset: Embraces cross functional initiatives, applying innovative learnings Identifies risks and plans mitigation.

Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources

learnings Identifies risks and plans mitigation.

Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

700万円～1200万円　

管理職候補としてモニターの管理や臨床試験一連のマネジメント業務を担っていただきます。

仕事内容

・プロトコル等の各種資材の作成義務、CROやその他委託先、ePROをはじめとする各種システム等の選定と管理
・モニター管理、その他担当プロトコル全般の問題対応等の臨床試験一連のマネジメント

応募条件

【必須事項】
・企業における、臨床開発組織の管理職経験
・英語力（TOEIC 730程度以上（目安））
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

750万円～　経験により応相談

抗癌剤プロジェクトのプロトコール作成に中心的に関わり、チームメンバーを率いて臨床試験を推進する臨床開発リーダー業務。

仕事内容

抗癌剤プロジェクトの臨床試験のプロトコール作成を推進し、スタディーチームをリードする

応募条件

【必須事項】
・抗がん剤（固形がん、血液がん）の開発経験（概ね3年以上）を有すること
・臨床試験推進のリーダー的な立場の経験を有すること
・Transformation・組織改革に果敢に挑戦するチャレンジ精神を有すること
・英語でのコミュニケーション力（英語で業務が十分できるレベル；TOIEC８00点程度以上）
・優れたコミュニケーション・プレゼンテーション能力
・課題を特定し対応策を提案できる課題解決力・論理的思考力
・チーム員および他部署関係者とも連携を図り良好な関係を構築するネットワーキング力
・固形がん、血液がんを含むがん領域の基礎・臨床知識の知識
・真摯さ、誠実さ
・チームプレーの経験
・適切なリーダーシップ
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

550万円～1000万円　経験により応相談

深い疾患理解に基づく臨床試験プロトコル骨子の作成

仕事内容

・適応疾患の検討および臨床開発計画（CDP）の立案
・開発段階に応じたTPP(Target Product Profile）の策定と成功確率の算出
・試験プロトコル骨子の作成
・海外カウンターパートや領域エキスパートなど国内外ステークホルダーとの交渉
・導入候補品の臨床科学的評価の実施
・申請業務に関連した薬制上の対応
・デジタル技術を活用した開発戦略の策定

応募条件

【必須事項】
・理系大卒（医・歯・薬・獣医学部など）以上
・医薬品臨床開発のクリニカルサイエンス業務の経験（3年以上，疾患領域は問わない）
・主担当としてプロトコル立案や開発戦略の策定に従事した経験
・または，上記2項目に該当しない場合，医薬品の非臨床開発の経験（5年以上）
・TOEIC800点以上か同等のビジネス英語スキル


【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円　

部門を超えた臨床業務ユニットを主導し、管理することにより臨床業務の効果を確実に提供

仕事内容

Purpose/Objective of the job
To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in CRO

Key Responsibilities and Major Duties
・ Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads to ensure timely execution consistent with R&D and local research goals and priorities
・ Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
・ Anticipates resource needs and provides workload evaluations and task assignments
・ Allocates and assign study resources in alignment with R&D and local research goals and priorities.
・ Supervises clinical trial execution at country level including supervising study metrics and team performance
・ Approves study fee funds and payments based on grant of authority
・ May propose and/or validate country study targets
・ May support Health Authority inspection and pre-inspection activities
・ May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
・ Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
・ Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met
・ Together with the CRO management tracks and manages performance metrics for Clinical Operations staff
・ Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
・ Point of Contact for FSP staff within the country
・ Managing the hiring, performance management and succession planning of staff
・ Performing general and human resource administrative functions
・ Participation in performance calibration and talent review meetings
・ Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
・ When managing all CRO staff in a given country, will represent CRO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
・ Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
・ Manage partnerships with critical accounts / sites

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Direct line reporting responsibility for CT Mgrs, CTMs, CTAs, Site Relationship Managers, Study Start-up Specialist and Site Contract Lead roles

Grade Level: D06

応募条件

【必須事項】
Degree/Certification/Licensure
Bachelors or Masters Degree within life sciences or equivalent

Experience - Responsibility and minimum number of years
・Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
・CT Monitor Line Manager - Prior monitoring experience required"
・Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
・Demonstrated ability to drive project related activities
・Previous supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team)
・Previous resource allocation experience preferred
・Experience mentoring and providing feedback to others

Competencies - knowledge, skills, abilities, other
・ In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
In depth knowledge and understanding of clinical research processes, regulations and methodology
・Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
・Demonstrated organizational and planning skills and independent decision-making ability
・Strong organization and time management skills and ability to effectively manage multiple competing priorities
・Outstanding interpersonal, oral and written communication skills to influence, inform or guide others
・Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance
・Microsoft Suite
・Clinical Trial Management Systems


Travel Required (nature and frequency)
Domestic travel to clinical trial sites
International travel where required
【歓迎経験】
・Degree/Certification/Licensure
Bachelors or Masters Degree within life sciences or equivalent
・Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs
・CT Monitor Line Manager - Prior monitoring experience required"
・Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
・In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

850万円～1200万円　経験により応相談

担当薬剤のさまざまな研究開発と市販後メディカルアフェアー業務をリードすることにより、患者さんのQOLの改善に貢献

仕事内容

ニューロサイエンス（精神・神経）領域において、医学、科学的な専門性にもとづいて、担当薬剤のさまざまな研究開発と市販後メディカルアフェアー業務をリードすることにより、患者さんのQOLの改善に貢献します。

・ニューロサイエンス（精神・神経）領域においての、メディカルアフェアーズ活動を医学専門家としてリード
・ニューロサイエンス（精神・神経）領域においての、臨床開発、すなわち臨床試験の計画、プロトコール作成、および試験遂行や、その結果に基づく承認申請・論文公表を医学専門家としてリード
・外部顧客（医学専門家、治験協力医師など）との良好なパートナーシップを維持

応募条件

【必須事項】
・日本の医師免許
・ニューロサイエンス（神経・精神）領域での臨床経験　5年以上
・ニューロサイエンス（精神・神経）領域の臨床開発およびメディカルアフェアーズ業務に興味のある方
・英語・日本語によるビジネスコミュニケーション能力（TOEIC 750以上（目安））
【歓迎経験】
・ニューロサイエンス（精神・神経）領域での臨床経験、臨床試験への参加の経験
・臨床試験プロトコール作成、もしくは査読付き論文作成の経験
・クロスファンクションをリードした経験
・製薬会社の経験は問わない、ただしあれば、尚可
・留学経験
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】兵庫

年収・給与

950万円～　経験により応相談

大手製薬メーカーにてワクチン領域の開発品の本邦臨床開発に関わる開発計画の立案かから資料作成まで担う

仕事内容

ワクチン領域の開発品の本邦臨床開発に係る以下の業務を担当：

・グローバル開発戦略における本邦臨床開発計画の立案・作成
・本邦で実施する治験の科学的側面からのリード
・臨床開発に係るPMDA相談資料の作成
・実施計画書の立案・作成（米国本社等、ステークホルダーへの説明・交渉を含む）
・ローカル試験：試験骨子から作成
・グローバル試験：日本で実施するために計画書を適性化
・他の治験関連資料（同意説明文書案、症例報告書、関連手順書、等）の作成サポート
・治験実施のサポート
・治験データのメディカルモニタリング
・治験総括報告書の作成（メディカルライターと協働）
・承認審査における臨床関連パートのリード
・承認申請資料（CTD）臨床関連パートの作成（メディカルライターと協働）
・臨床関連照会事項に対する回答作成
・治験に関する学会発表及び／又は論文作成、あるいはそれらのサポート

応募条件

【必須事項】
・製薬企業における臨床開発経験（５年以上）
・医学、薬学あるいは生命科学に関する学位（修士以上）
・バイオ医薬品開発に関連する領域の研究経験（3年以上）
・未経験分野にチャレンジするフロンティア精神とリーダーシップ
・国内外のチームメンバー及び社内外のステークホルダーと密接に協同するためのソフトスキル
・英語力：TOEICスコア800点以上（目安）に相当する英語力

【歓迎経験】
・ワクチン、バイオ医薬品又は再生医療等製品に係る業務経験
・医薬品臨床開発業務の経験、特に治験実施計画書の作成経験
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

650万円～1100万円　経験により応相談

日本における臨床開発のための部門横断的な議論においてプロジェクト管理を保証

仕事内容

・日本における臨床開発のための部門横断的な議論においてプロジェクト管理を保証する
・日本から企業や他の地域に戦略的提案を提供する
・日本での臨床開発の成功と患者にとっての製品の価値の最大化を可能にする

Accountabilities
Sets up and leads a cross-functional team in Japan (i.e., Japan Core Team) to make strategic proposals and/or resolve cross-functional issues for clinical development.
Manages timelines and information collected from internal and external stakeholders to make strategic proposals.

Ensures strategic proposals made by the Japanese team are aligned with/endorsed by the management in Japan

Ensures that the progress of clinical development projects is communicated to the Japanese team and management for making or updating strategic proposals whenever necessary during the course of clinical development.

Assists in discussions for assigned projects at the challenge committee in Japan (i.e., Japan Development Committee) and documenting the decisions as a secretariat.

Contributes to the global team as a Regional Integration Lead (RIL) by discussing and negotiating strategic proposals from Japan with the global team and reviewing that the Clinical Development Plan (CDP) and/or the Target Product Profile (TPP) reflects the proposals in support of product milestone releases at the Human Pharma Steering Committee.
Leads a cross-regional RIL team when assigned as the Coordinating RIL of a particular clinical project and facilitates communication between the global team and the RIL team.

・Ensures close partnerships with key stakeholders across Medicine, Marketing, Market Access, Research & Development, and International Project Management and/or regions (with focus on Asian markets) and synergy, acting as the liaison between Medicine and Business functions.
・Assists in implementation of global RIL strategies and processes.
・Supports development of peers.

・Regulatory and / or Organisational Requirements
・Follows government regulations and company standard operating procedures relevant to clinical development process.
Be compliant and acts within ethics at all times.

Job Complexity：
・Manages on a daily basis multiple stakeholders at all levels in different functions and regions of the organisation.

Interfaces：
・Leads the Japanese team and participates in global teams for clinical development.
Participates in the challenge committee in Japan as a secretariat.

Job Expertise：
・Provides project management for cross-functional discussions and takes a high degree of initiatives to balance multiple priorities based on strong knowledge of clinical development processes and related interfaces including medical, regulatory and market access environment and requirements.

Job Impact：
・Responsible for ensuring that Japanese needs are appropriately reflected in CDP and TPP.

応募条件

【必須事項】
・修士卒以上
・製薬業界での8年以上の経験
・臨床開発および医薬品開発における4年以上のプロジェクトマネジメント経験
・4年以上国際的な業務経験がありビジネスレベルの英語力をお持ちの方
【歓迎経験】

【免許・資格】
プロジェクトマネジメントプロフェッショナル（PMP）尚可
【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

850万円～1200万円　経験により応相談