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Senior Medical Director Therapeutic Area (Medical…

【Purpose Scope】 ・Accountable and responsible for development and implementation of a global medic…

求人会社名:アステラス製薬株式会社

メンバー
1500万円~1800万円

募集要項

  • こだわり条件

    従業員1000名以上 設立50年以上 語学(英語)を生かす 年間休日120日以上 土日祝日休み

  • 仕事内容

    【Purpose Scope】
    ・Accountable and responsible for development and implementation of a global medical development plan on a large complex late phase project or on a group of complex
    earlier phase projects.
    ・Serves as global medical lead (GML) on one or multiple Astellas Pharma Global Development (APGD) Core teams including late stage and complex projects.
    ・Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
    ・Responsible for the medical interface with research through regulatory authorities and the commercial organization.
    ・Provides medical leadership on the Global Project Team and chairs the Global Clinical Team meetings.
    ・Supports to other projects as required.

    【Essential Job Responsibilities】
    ・Accountable and responsible for design and final recommendations in clinical development plan for their drug (s) after soliciting appropriate input and review from colleagues within Regulatory Affairs Commercial and Medical Affairs (Global and Regional) Manufacturing Clinical Pharmacology Statistics Health Economics and Outcomes Research and other line functions.
    ・Leads the global medical team(s) to design implement and conduct multi phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval.
    ・Leads APGD medical programs when required as part of post marketing requirements.
    ・Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Global Development Project Leader (GDPL)).
    ・Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
    ・Negotiates milestones and ensures clinical development objectives are met (in conjunction with Global Project Development Leader).
    ・Plans for resources required both within the Medical Sciences organization and in conjunction with the Global Development Project Lead (GDPL) and the Glob…

  • 職種分類

    素材・化学・食品・メディカル系技術者 > 医療・医薬・メディカル系技術者 > 研究・開発(医療・医薬・メディカル)

  • 業種分類

    医薬・バイオ

  • 応募条件

    【Qualifcations】
    The candidate must be a strong physician scientist with several years of experience in the global pharmaceutical industry.
    Capable of designing and executing clinical development plans providing medical leadership to a project team and to junior medical staff providing clear updates on progress to milestones and strong medical and product development acumen to programs and the team.
    <Required>
    ・Medical Degree (or Medically Qualified) with post graduate qualification and specialization in the appropriate specific therapeutic area/or one of the groups preferred
    ・Should have at least 5 years relevant experience in drug development in a biotech/ pharmaceutical company or equivalent experience in an academic clinical research role(NCI NIH Academic Research groups etc)
    ・Proven record of being a successful medical leader and a study clinician.
    ・Experience managing drug development programs.
    ・Experience designing implementing and conducting clinical studies to produce both timely and high quality data.
    ・Proven ability to get results in a matrixed management environment

    <Preferred>
    ・Additional post doctoral training or additional qualifications such as PhD PharmD certificate in Pharmaceutical Medicine highly desirable
    ・Prior experience in leadership role in EU/US regulatory filing.

  • 年収

    1500万円~1800万円
    1500万円 - 1800万円

  • ポジション

    メンバー

  • 雇用形態

    正社員

  • 勤務地

    東京都

  • 勤務時間

    08:45 ~ 17:45

  • 休日・休暇

    【有給休暇】15
    【休日】完全週休二日制


    祝日
    GW
    夏季休暇
    年末年始
    ※有給休暇:4月入社の場合、初年度15 日 ( 1 か月目~ )以降、入社月に応じて変動
    土日、祝日、年末年始、夏季休暇、慶弔休暇、赴任休暇、特別療養休暇、看護休暇、生理休暇、骨髄ドナー特別休暇他

    詳細はオファー時に通知いたします

  • 福利厚生

    【通勤手当】全額支給 当社規定により支給あり(上限5万円/月)
    【社会保険】健康保険
    厚生年金
    雇用保険
    労災保険
    【その他手当】住宅手当

求人会社情報

  • 設立

    Apr-23

  • 資本金

    103001(百万)円

  • 従業員

    15455人

  • 事業概要

    医薬品の製造・販売および輸出入

職種PR

アステラス製薬株式会社での募集です。
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