therapeutic area through the total process of the clinical development phases, in collaboration with

仕事内容

Keep development timeline
Description of Japan needs, plans and timeline in the CDP
Continuously update Japanese development plan and issue with TMM(s).
Confirm “Integration of Japan” section in Management Summary is
correctly reflecting updated Japanese situation.
Ensure adequacy of Japanese submission package and adequacy of trial
design.
Integrate feedback from the aspect of “post launch” medical needs into
Japanese clinical development plan in the therapeutic area.
Japanese version IB update within 3 months after global IBP update
Maximize external expert engagement in order to gather valuable
Writing crinical overview in CTD and supervise of module 2 as clinical
scientific reviewer
Ensure Japanese RMP (Risk Management Plan) document is sufficiently
qualified as a part of J-CTD.
Responsible for the clinical part until approval, such as preparation of
responses to PMDA queries.
Confirm project level documents related with regulatory interaction.
PMDA consultation meeting materials and answers to PMDA inquiries.
Advice to trial team about eligibility of patients when requested.
Yearly budget management within ± 10%
Keep approprite FTE for project
Provide project overview to HPDC (collaboration with PM (Project
Management) Group)
Assess respective therapeutic area compounds’ safety profile in
collaboration with Safety Evaluation Committee (SEC) and external
medical advisor(s) in the therapeutic area
Supports market access activities（pricing negotiation，proper use
promotion etc.）where necessary
Transfer knowledge and network through clinical development to Medical
Affairs function and other relevant business function(s).
Support medical affairs to build evidence in Asia and Japan
Build network with key Japanese external experts through clinical
development in collaboration with Medical Affairs Group
Provide training to members in Clinical Development
Support Medical Affairs Leader to educate/train colleagues in other
functions (MSL, Marketing, etc.)

応募条件

【必須事項】
TA experience in clinical or research setting with or without own publications, 3+ years industry experience in
Japan in Clinical Drug Development and Medical Affairs. Leadership.
The therapeutic area in either clinical development or
clinical practice more than 5 yrs
【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～800万円

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

応募条件

【必須事項】
・理系大卒（医・歯・薬・獣医学部など）以上
・医療用医薬品の臨床開発経験者で，特にプロトコル立案や開発プランの策定に従事した経験がある者（疾患領域は問わない）
・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

アジア、アメリカ、ヨーロッパ地域の臨床事業における研究の遂行実績、戦略的取り組みおよびコミュニケーションの管理を支援

仕事内容

This role will be the strategic and operational partner to the Head of Regional Clinical Operations Asia/Americas/Europe and specifically support the management of budget, resources, study country allocation, study execution performance, strategic efforts and communications.

Key Responsibilities and Major Duties
・Assist functional leaders in delivering transformative operating model enhancements that improve pipeline delivery and enhance business performance
・Assisting functional leaders in the design and implementation of short- and long-term business strategies
・Manage resourcing model for the region and help manage workforce management plan in collaboration with CTP&OE; and RDSP
・　Manages regional budget to ensure proper and efficient use of allocated budget
・Support communication flow and plan for the region, including creating materials for regional and global meetings. Work with Country Clinical Operations Heads to plan annual Lead Country Unit Meetings
・Assure that initiatives within the region are kept on track and managed effectively through use of formal Charter review and approval process, and oversight involvement in key global initiatives
・Drive & coordinate regional input to the synopsis, country allocation & site identification at the country-level with CTP&OE; & Country Clinical Operations Head, and be responsible for the creation of the operational execution plan across the region in collaboration with CTP&OE;
・Line management of one or more Vendor Operations Managers, assuring the application of a unified and robust Vendor management & oversight process for countries with challenging clinical outsourcing environments in the region.
・Drive & coordinate regional review of study execution progress and overall performance metrics.
・Work with RCO Head to implement strategies to develop people and culture in alignment with GCO and company
(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Supervisory Responsibility
・Direct line management of Vendor Operations Manager(s)

Key Stakeholders/Contacts
・Major customers are study teams across R&D including senior managers as well as external customers e.g. CROs, academic institutions, and other external suppliers.

応募条件

【必須事項】
・製薬業界またはヘルスケア関連業界における最低8～10年の関連する業務経験
・臨床研究研究の運用面での強力なバックグラウンドを持つ、実証済みのプロジェクト管理経験
・臨床研究のプロセスと規制についての深い理解
・非常に強力な書面および口頭によるコミュニケーションスキル、ならびに強力な対人関係および組織的スキル
【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

800万円～1300万円

部署の体制強化のための増員募集となります。

仕事内容

・海外臨床試験の取扱いや、FDA申請業務
・海外医師、メーカーとのコミュニケーション（電話、面談）

応募条件

【必須事項】
必須条件：
・ビジネス英語によるメール作成、および英文読解力
・理系大学程度の知識（生物・化学系、医薬系）

【歓迎経験】

歓迎条件：
・医学統計、法規制、臨床試薬に関する知識
・外部とのコミュニケーション能力（電話、面談）
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】新潟

年収・給与

400万円～500万円