医師転職・バイトは民間医局

東京都・内科・外科の常勤医師求人（26-JQ313660）

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    • 常勤
    • 企業
    • 土・日・祝休み可

    大手外資系製薬メーカーでの就業です

    掲載更新日 : 2026年06月16日   案件番号 : 26-JQ313660

    担当エージェントより

    募集形態：Japan Program Clinical Head (CRM)
    対象専門科目：内科、外科、膠原病科
    勤務地：東京都
    勤務地
    東京都
    路線
    科目
    内科・外科
    勤務内容
    メディカルドクター
    勤務内容詳細
    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
    →備考に続く
    給与
    ～1,500万円（スキル・経験による）
    勤務日数
    週5日（月～金曜日）
    日程/時間
    本社・事業所勤務：9:00～17:45（就業時間7時間45分）※外勤は事業所外みなし労働時間に関する規定を適用。左記以外はフレックスタイム制規定を適用。 ※休憩時間：60分
    オンコール
    休暇・研究日
    完全週休2日制、祝祭日、年末年始、ゴールデンウィーク、夏季休暇、年間休日125日（前年度参照）、有給休暇（初年度15日、次年度20日）
    勤務開始時期
    応相談
    医療機関情報
    医療機関形態：企業

    屋内の受動喫煙対策：あり（禁煙）
    備考
    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


    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

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内科系 外科系 内科・一般内科 外科・一般外科 関東 東京 企業 土・日・祝休み可

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