Department Manager, Clinical Programming

2週間前

Tokyo GSK OTHER
Nama Site: Japan - Tokyo - Akasaka
Tanggal Posting: Apr

GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people worldwide.

We are seeking an experienced programmer to lead the Japan clinical programming team. This is an exciting opportunity to actively contribute to the GSK Japan organization, through delivery of accelerated and quality submissions, embracing new technologies to support efficient ways of working and influencing the external programming environment.

GSKは、サイエンス、テクノロジー、人財を結集し、力を合わせて病に先手を打つ、という高い志と存在意義を持った、バイオ医薬品のグローバルリーダーであり、世界中の何十億人もの人々の健康に貢献しています。

GSK Japanは日本のクリニカルプログラミングチームを率いる経験豊富なリーダーを募集しています。本ポジションは、質の高い成果物を迅速に提供すること、新しいテクノロジーを活用して作業の効率化を支援すること、また社外活動により製薬業界にも影響を及ぼすことなどにより、GSK Japanの業績に積極的に貢献することができるエキサイティングな役割を担います。

As head of the clinical programming group:

  • Acts as an expert in relation to Japan submission regulations and collaborates with other regions to ensure efficiency in global development
  • Takes accountability for quality of deliverables within department, including execution of analyses and submission documents, planning the resource strategy, with accountability for budget, CRO oversight and cycle times of deliverables.
  • Acts as an expert representing programming function on departmental and cross-departmental initiatives providing input and influencing groups outside of own discipline
  • External visibility and active in cross industry working group to influence the future direction of programming within Japan
  • Allocates decision-making authority and task responsibilities to appropriate direct reports / team members, utilizing time, skills, and potential effectively
  • Proactively supports development of team, working with individuals to set stretched goals aligned to business need and plans/creates development opportunities.
  • Promotes new innovations and efficient ways of working.

クリニカル・プログラミング・グループの責任者の役割:

  • 日本の新薬承認申請に係る規制に関する専門家として、他国のGSKと連携しながら効率的にグローバル開発を行う
  • 部門内の成果物の品質の担保、臨床試験の解析や申請用業務の遂行、計画的なリソース戦略と予算の立案、外部委託業務管理、成果物のサイクルタイムラインの管理に対して責任を果たす
  • 部門内および部門を越えた取り組みにプログラミングの専門家として参画し、必要な情報を提供するとともに他部門に影響を与える
  • 製薬業界内のワーキンググループで活躍し、社外からも存在が認識され、日本のプログラミング業界の将来の方向性に影響を与える
  • 時には意思決定権限やタスクの責任をメンバーに適切に委譲することで、チームの時間・スキル・能力を効果的に活用する
  • ビジネスニーズに沿った挑戦的な業務目標をメンバーと協力して設定し、チームが成長できる機会を計画/創出することで、チーム全体の能力開発の支援を積極的に行う
  • 新たな技術の革新とそれによる働き方の効率化を促進する

※職務内容および勤務地の変更範囲は会社の定めるところとする。

必要な条件 / Basic Qualification:

スキル / Skill

  • Statistical programming and leadership experience in clinical R&D is required
  • Advanced proficiency in one or more programming languages, such as R, Python, and/or SAS
  • High communication and negotiation skills in written and spoken Japanese and English
  • 臨床研究開発、特に統計プログラミング分野で発揮できるリーダーシップ
  • R、Python、SASなどの1つ以上のプログラミング言語を高度に習熟していること
  • 日本語と英語の双方における高いコミュニケーション能力・交渉能力(筆記、口頭とも)

経験 / Experience

  • Experience in leading a team, either as direct manager or as part of a cross-functional effort
  • Experience of New Drug submission to PMDA and/or FDA/EMA at Pharmaceutical companies.
  • ラインの管理職として、または部門横断的なタスクのリーダーとしてチームを引率した経験
  • 製薬会社における、各国の規制当局(PMDA、FDA、EMA)への新薬承認申請の経験

学位・資格・語学力 / Education・Certification・Language

  • A BSC, BA or equivalent in Mathematics, Statistics, Computer Science or related subject
  • 数学、統計学、コンピュータサイエンス、または関連科目の学士号(BSC、BA、または同等のもの)

望ましい条件 / Preferred Qualification

スキル / Skill

  • Expertise in therapeutic area specific requirements
  • Expertise in representing programming function in cross-functional meetings, initiatives, and working group
  • 各治療領域に関する専門知識
  • 部門横断的な会議やワーキンググループ等の取り組みで、プログラミング部門を代表できる専門知識

経験 / Experience

  • Experience with working within a global team and managing expectations across different time zones
  • Strong interest in or experience contributing to external organizations (e.g., PHUSE, PharmaSUG, etc.)
  • グローバルチームでの業務経験や、異なるタイムゾーンにおける成果の管理経験
  • 外部活動(PHUSE、PharmaSUG等)へ強い関心があり、実際にその活動に貢献した経験

学位・資格・語学力 / Education・Certification・Language

  • MSc or PhD (or equivalent) in Mathematics, Statistics, Computer Science or related subject preferred
  • 数学、統計学、コンピュータサイエンス、または関連科目の修士号または博士号(MSc、PhD、または同等のもの)

Tujuan kami adalah menjadi salah satu perusahaan perawatan kesehatan yang paling inovatif, berkinerja terbaik, dan tepercaya di dunia. Kami meyakini bahwa kami semua membawa sesuatu yang unik ke GSK, dan dengan memadukan pengetahuan, pengalaman, dan gaya kami, dampaknya akan luar biasa. Bergabunglah dengan petualangan kami di GSK, di mana Anda akan terinspirasi untuk melakukan yang terbaik bagi pasien dan konsumen kita. Tempat di mana Anda menjadi diri sendiri, merasa baik, dan terus berkembang.

Pemberitahuan penting kepada Bisnis/Agen ketenagakerjaan

GSK tidak menerima rujukan dari bisnis ketenagakerjaan dan/atau agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini. Semua bisnis/agen ketenagakerjaan harus menghubungi departemen pengadaan komersial dan umum/sumber daya manusia GSK untuk memperoleh otorisasi tertulis sebelum merujuk kandidat ke GSK. Mendapatkan otorisasi tertulis sebelumnya merupakan prasyarat sebelum perjanjian apa pun (lisan atau tertulis) antara bisnis/agen ketenagakerjaan dan GSK. Jika otorisasi tertulis tersebut tidak diperoleh, maka tindakan apa pun yang dilakukan oleh bisnis/agen ketenagakerjaan akan dianggap telah dilakukan tanpa persetujuan atau perjanjian kontrak dengan GSK. Dengan demikian GSK tidak bertanggung jawab atas biaya apa pun yang ditimbulkan oleh tindakan tersebut atau biaya apa pun yang ditimbulkan oleh rujukan apa pun oleh bisnis/agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini.

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