求人詳細
| 非公開求人 東京都 MD-409 |
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2026.06.23 更新
＜NEW＞
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Japan Program Clinical Head (CRM)
大手外資系製薬メーカーでの就業です。（転職：医師求人）
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| 勤務内容 2026.06.23更新 | |
| 募集科目 |
一般内科
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| 日勤の仕事 |
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| オンコール | なし |
| 備考 | Education: Advanced degree in life sciences/healthcare (or clinically relevant degree: MD or equivalent, PhD, PharmD degree is preferable) required. Specialization in a subspecialty may be needed. Advanced clinical training/knowledge in medical/ scientific area aligned with TA required. Experience/Professional requirement: ≥5 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV, including submission dossiers (In case MD holder, equivalent medical experience is needed) Thorough knowledge of GCP and GPSP, clinical trial design, statistics, and regulatory/clinical development process Experience with submissions and/or health authorities required Demonstrated ability to establish strong scientific partnership with key stakeholders Demonstrated leadership and team management skills with a documented track record of delivering high quality projects/submissions/trials in pharmaceutical or biotech industry Considerable organizational awareness including extensive experience working cross-functionally and in clinical teams Excellent management, interpersonal, communication (both written and oral), and problem-solving skills Excellent negotiation and diplomatic skills English Skill: Fluent (or intermediate) oral and written English" "Job Description Summary The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or multiple compounds. The JPCH closely works with Japan Project Head (JPH) as well as Global Program Clinical Head (GPCH) and inputs the risk benefit assessment for the program(s), and as the member of Global Clinical Team(s) (GCT) provides the inputs regarding the design, implementation, and execution of a clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view. The JPCH may contribute to disease area strategy. Job Description １．Is an extended member of the GCT as representative of Clinical Development Japan (CD-J) ２．Is a member of JPT and drive the clinical development in Japan ３．Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD ４．Post-DDP, lead the development and execution of Japan clinical strategy. Provides Japan inputs to GPCH for developing an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful regulatory approval/market access for one or multiple treatment indications and/or multiple programs in Japan ５．Is responsible for Japan input to the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, Re-examination application dossier, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with CDP and TPP. Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, J-RMP, clinical benefit- risk assessment for license renewals) for the compound(s) ６．As the medical/scientific expert, contribute interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), Japan internal stakeholders (e.g., JPT, GDO/Trial management, Research, Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV), Health Economics & Outcomes Research, etc.), and internal decision boards lead clinical related health authority (HA) activities including development of briefing book and answers for questions from HA ７．Contribute to development of TA strategies (Rheumatology area) ８. Provide on-boarding, coaching, and/or mentoring support; develop and foster Clinical Development culture ９. Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures １０． 100% timely delivery of all training requirements including compliance ※記載の件数等は目安の数字です |
| 求人の特徴 |
勤務条件 原則オンコール呼び出しなし、土・日・祝休み、当直なし |
| 勤務日時 2026.06.23更新 | |
| 勤務日 |
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| 勤務時間 |
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| 休憩時間 |
60分
(概ね 12:00〜13:00)
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| 勤務条件 2026.06.23更新 | |
| 給与 |
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| 制度その他 | 雇用期間 有期 ※個別相談の可能性有/試用期間 有り ※個別相談の可能性有 |
| 契約期間 |
契約期間の定め
なし
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| 契約更新 |
更新
なし
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| 試用期間 |
試用期間の定め
あり
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試用期間
勤務開始日から3ヶ月
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試用期間中の労働条件変更
なし
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| 勤務開始時期 | 応相談 |
| 退職に関する事項 |
定年制
あり
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定年
60歳
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継続雇用制度
あり
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自己都合退職に関する手続き
就業規則による。退職は1ヶ月前までに申し出ること。
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解雇の事由および手続き
就業規則による。
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| 受動喫煙対策 |
対策
あり
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施設内における全面禁煙の実施
あり
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喫煙室の設置
なし
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| 勤務場所 2026.06.23更新 | ||
| 所在 |
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| 施設 |
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| 募集要項 2026.06.23更新 | |
| 選考方法 | 面接あり |
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| 提出書類 |
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| 照会先 |
■Dr.なび運営会社 株式会社エムステージ 医師担当コンサルタント宛て □連絡先 東京本社 TEL：0120-148-506 Email：cp@mstage-corp.jp 東京都品川区大崎2-1-1 ThinkPark Tower 5F https://www.mstage-corp.jp/ |
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