東京都千代田区・膠原病科・リウマチ科の常勤医師求人(25-JQ306054)

    • 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 : 2025年08月06日   案件番号 : 25-JQ306054

    担当エージェントより

    募集形態:Clinical Trial Physician
    対象専門科目:膠原病・リウマチ内科、耳鼻科・皮膚科・内科・整形外科
    勤務地:東京都千代田区
    勤務地
    東京都千代田区
    路線
    科目
    膠原病科・リウマチ科
    勤務内容
    メディカルドクター
    勤務内容詳細
    Medical Monitoring
    Conducts medical data review of trial data, including eligibility review
    Holds responsibility for site interactions in partnership with the Japan Clinical Lead or Clinical Scientist for medical questions and education (including safety management guidelines)
    Holds responsibility for assessment of key safety-related serious adverse events of R&D clinical trials in partnership with Worldwide Patient Safety and oversees safety narratives
    Collaborate with Japan Clinical Lead or Clinical Scientist and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations)
    Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
    The range of CTP’s medical accountability/responsibility differs in global vs local studies. For global studies, Japan CTP is assumed to assist global CTP as needed from local perspectives, e.g. provide local medical related input, resolve local medical related issues.
    Japan CTP could be expected to take a primary CTP role for local initiated trials or program
    Clinical Development Expertise & Strategy
    In collaboration with the Japan Program Development Team such as Clinical Lead, designs and develops project/clinical plans and protocols with a strong strategic focus based on knowledge of asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
    Provides oversight and medical accountability for a group of studies
    Leads the analysis of benefit/risk for clinical development protocols and projects in a matrix team environment working with Japan TA
    Partners with Japan the Japan Program Development Team such as Clinical Lead to support executional delivery of studies (e.g., enrollment review, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
    →備考に続く
    給与
    年収1,000万円~(目安の金額になります)
    ※経験・スキルによります。
    勤務日数
    週5日(月~金曜日)
    日程/時間
    9:00~17:15(実働時間7時間15分) フレックスタイム制あり ※休憩時間:60分
    オンコール
    休暇・研究日
    完全週休2日制、国民の祝祭日、創立記念日、年末年始、公民権行使・公務休暇、生理休暇、ドナー休暇、社内ボランティア休暇、有給休暇(勤務年数に応じて付与最高20日/年)、その他慶弔休暇など
    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
    Identifies and builds relationships with principal investigators. Identifies and cultivates thought leaders in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge, and design of clinical development studies and programs
    Maintains a strong medical/scientific reputation within the disease area. Has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. Holds strong expertise in the disease area by attending scientific conferences and ongoing review of the literature
    Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
    Provides ongoing medical education in partnership with collaborating Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
    Health Authority Interactions & Publications
    Contributes to and serves as medical point of expertise in key Health Authority interactions and advisory board meetings as Clinical Trial Physician
    Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with TA such as Clinical Lead or Clinical Scientist


    【必須条件】
    ・医師免許
    ・臨床開発全般に関する5~10年の経験に相当する深い知識
    ・医薬品開発プロセス全体とその規制ガイダンス/ガイドラインに関する幅広い知識
    ・予算計画およびリソース管理のスキル
    ・ビジネスレベルの英語力

    【歓迎スキル】
    ・博士号

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