クリニカルリサーチ - バイオ製薬企業

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お問合せ Eureka Teramura
参照 JO-2012-452275
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※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
外資系バイオ製薬企業

  • 感染症治療の製品を中心に事業を展開しています
  • 専門知識やスキルに関するトレーニングも充実しています
  • グローバルは大きいが日本では小規模なので一丸となってビジネスを拡大していける
  • HQとのつながりが深く、本国と入り込んで一緒に仕事が出来る
  • 組織がコンパクトな分、上層部の意思決定もスピーディ
  • 大手企業に比べ一人一人の職責範囲が広く、新薬の開発プロセスにより深く関われる環境
  • 主体的に動ける。自分で試行錯誤し、開拓できる・やりがいが感じられる
  • 幅広くチャレンジングな仕事に取り組める。経験が偏っている方はここで経験の幅を広げられる
  • Cross functionalでコミュニケーションが多く発生する
  • 穏やかで協調性の強い方が多い
  • 希少性の高いパイプライン
  • オンコロジー領域の日本参入のパイオニアメンバーとして会社を背負っていく
  • ハンズオンでいながら組織作り・会社の運営にも貢献出来る

[Responsibilities]
Reporting to the Therapeutic Area Lead of Clinical Research Japan, the Senior Manager or Associate Director (SM/AD) in Clinical Research plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for company's development compounds in oncology, liver disease inflammation and HIV therapeutic area.

Although generally assigned to a specific therapeutic area, the SM/AD may support local clinical research activities across development programs.

※業務の詳細はご紹介時にお伝えします。

[Requirements]

  • MS degree or above.
  • Minimum of 3-7 years of experience (depending on the grade) within clinical research / clinical development.
  • Experiences in preparing the CTD and query responses in JNDA.
  • Leadership and project management skill to drive clinical development of new therapies in Japan.
  • Communication skill enabling timely information sharing with Foster City and other functions at Gilad Japan.
  • Problem solving skill to analyze the problem and develop/execute action plans.
  • Medical writing skill to prepare study protocols and regulatory documents related to clinical.
  • Negotiation skill with investigators and officials in the Health Authorities to move the study forward.
  • Deep knowledge of clinical guidelines and regulatory requirements.
  • Extensive experiences in clinical development to put together the best and fastest development strategy.
  • Up-to-date expertise in the responsible therapeutic area.

[Employment Type]
Full time

[Salary]
15M-25M yen
※Experiences and skills will be considered

[Location]
Tokyo


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Further details about the company and position will be notified at a later date.