東京都新宿区・内科・小児科の常勤医師求人(25-JQ304650)

    • 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06月13日   案件番号 : 25-JQ304650

    担当エージェントより

    募集形態:Global Clinical Development Strategy Expert
    対象専門科目:内科、小児科、免疫内科、感染症内科
    勤務地:東京都新宿区

    【必須条件】
    ・医師免許
    ・3~5年以上の臨床経験 ※小児科または内科の研修に加え、免疫学または感染症の研修または経験
    ・疫学、公衆衛生、感染症研究の経験
    ・ビジネスレベルの英語力

    【歓迎スキル】
    ・博士号
    勤務地
    東京都新宿区
    路線
    科目
    内科・小児科
    勤務内容
    メディカルドクター
    勤務内容詳細
    CDP implementation

    As team leader of the clinical study team, is accountable for the implementation of all clinical activities to move vaccine candidates through development, registration and commercialization in accordance with established ICH-GCP guidelines.

    Collaborates closely with Medical (GME/PMSL), Clinical Study Management teams in site and investigator selection and discusses options to ensure alignment with the CDP after obtaining input from regional stakeholders such as medical affairs representatives, regulatory affairs, etc.
    Engages in discussion with Clinical Operations Leader, Clinical Study Management, GBS and other members of the clinical team to ensure that studies are feasible and meet ICH-GCP quality and compliance standards; is a key source of information and education for internal and external stakeholders on ICH-GCP and regulatory requirements.
    Is accountable for global protocol and amendments development in order to obtain regulatory approval; ensures consistency across trials in the project in terms of site selection approval process, safety data quality review, audit preparations, study specific safety follow-up reports, interim analysis, iCSR and dear investigator letter development.
    Follows a consistent format and approach to investigators meetings, independent data monitoring committee meetings, safety management team meetings, product safety board meetings, clinical-regulatory strategic forum presentations, project team meetings.
    As appropriate, the lead GCDSE will support other GCDSEs to align on the CDP in the management of activities in their respective country/region.
    Project Planning and Reporting

    Is the clinical representative in the Global Project Team, or supports the Senior Global Clinical Development Strategy Expert in their role as primary clinical representative.
    →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、年末年始、公民権行使・公務休暇、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
    Is accountable for the timely reporting of project status to senior management and ensuring execution of project deliverables in coordination with clinical team members.
    Provides details of clinical assumptions that need to be factored into timing considerations, budgetary and resource planning processes.
    Regulatory Support

    Provides clinical input to regulatory strategy and submissions for clinical studies they are leading:

    Leads the creation of medical/clinical content of study documents (including briefing packs) and validates with GSO SAE management processes for the study, in conjunction with Global Pharmacovigilance and other representatives of the Project Team.
    For CTD/local dossier preparation:
    Responsible for the review and approval of clinical sections of the Common Technical Document/local dossier for submission for licensure
    Responsible for responding to clinical questions relating to the CTD/local dossier from Health Authorities
    Coordinates clinical development responses to health authorities (ethical committees, national regulatory agencies, ministries of health), to assure consistency, engaging other GCDSEs, central / regional /local teams and clinical operations as needed, in conjunction with the central RA representative of the Project Team.
    Attends relevant meetings with CTD task force and RA meetings relating to licensure.
    Interacts with regulatory authorities and other external parties as appropriate to review the conduct and / or data from the clinical program; engages in 'end-of-phase' meetings to discuss scientific points, Q&A on submitted data.
    Epidemiology

    Provides clinical and scientific support to epidemiology studies that are led by the epidemiology platform.

    Medical Monitoring

    Brings medical and scientific expertise to bear when acting as the medical monitor for clinical studies:

    Provides medical guidance related to the safety and wellbeing of study subjects and is responsible for ensuring the safety of research subjects in clinical trials*. (*If not a physician, requires supervision by a physician)
    Is the medical expert on call for site audits and inspections. (will delegate as appropriate to GCDSE in regions or countries)
    Proactively communicates any potential issues to central / regional teams and clinical R&D management and plays an active role in solving problems and issues.
    Medical/Scientific Data Interpretation and Communication

    Ensures a consistent, systematic approach to the analysis and interpretation of efficacy, immunogenicity and safety data. Leads the interpretation and critical evaluation of study results. Authors and reviews clinical study reports and clinical documents required for regulatory submissions.

    Meets with a) the (extended) clinical team and b) the global project team to report and discuss results. Also engages Global Head of Clinical Franchise as appropriate for review and discussion of results; includes analysis of data, impact on strategy, risk analysis, possibility of modifying program.
    Makes recommendations to Clinical Regulatory Strategic Forum (CRSF).
    For Publications:

    Contributor to the preparation and review of the Publication Plan/Integrated Scientific Communication Plan (iSCP).
    Clinical Development representative of the Publication Working Group (PWG) and, when applicable, the Publication Steering Committee (PSC).
    Author/Co-author of the publications of the study they are involved in.
    Attend/present results in Scientific Meetings or Congresses.
    As an ambassador for Clinical R&D is accountable for:

    Preparation of presentation materials; presents study results internally to senior management and presents externally to investigators, outside partners, regulatory and public health agencies.

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