求人詳細

NEW

R&D CS, Head of Neuroscience TA Clinical Development Departmen

コンサルタントから…

大手外資製薬会社 R&D CS, Head of Neuroscience TA Clinical Development Departmen

募集要項

業務内容

Compound life cycle management:
・ Leads Japan Compound Team by co-working with Associate Director to develop Integrated Evidence Generation Plan that to be approved at annual ISD process and/or relevant MC meeting such as strategy MC.
・ Leads R&D KOL management.
Development planning and execution:
・ By co-working with Associate Director, develops Japan Development Plan that to be approved at JSRB and executes all approved studies and/or any activities.
・ Provides leadership, as Responsible Medical Officer or its local delegate, to execute clinical studies in Japan whatever local or global from study start to study completion, and study report creation including original article/presentation publication.
・ Provides leadership to file CTD as JNDA including labeling discussion.
・ Approves the members of study implementation structure of Japan company each of clinical studies which are conducted in Japan.
・ Executes own authority defined in the “authorization matrix” attached.
Post marketing activities:
・ Contributes to launch readiness development.
・ Supports to develop risk management plan including post marketing surveillance studies led by JSS. (Japan Safety)
・ Provides leadership to execute post marketing clinical study from early preparation to completion if post marketing clinical study in Japan is considered.
Reporting lines and talent pipelines:
・ Responsible to assign Associate Director(s) to be reported to Head of TA-Dev.
・ Responsible for assessing potential in-house scientist/physicians, identifying gaps in the talent pipeline and providing opportunity to region/global.

求められる経験

Experience/Knowledge
・ 5 years of pharmaceutical industry experience overall including clinical
development experience at least three years. Preferable to demonstrate
leadership in at least one development program which led to successful clinical
trial execution and registration in Japan.

Skills/Capabilities
・ Demonstrates ability of strategic thinking and contingency planning with respect to pharmaceutical objectives.
・ Strong oral and written communication skills in both English and Japanese.
・ Good planning and tracking skills.
・ Demonstrates influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority.
・ Good problem solving skills for developing creative solutions.

Qualification/Certificate
・ M.D., Ph.D., or equivalent is required.

求められるスキル

CRITICAL LEADERSHIP IMPERATIVES:
・ Builds strong and positive relationships with MC members, senior R&D leaders and partners, colleagues and related functions.
・ Identifies unsolved needs per insights, and find effective solutions thought-out company-wide collaborations.
・ Delivers add-value solutions from insights, and challenge against status-quo for positive change onto the organization.
・ Takes risk and manage it without jeopardizing quality and/or compliance.
・ Responses talent development, talent fulfillment, and performance improvement, by having diverse visions, experiences, and ability.
・ Contributes high performance organization by transparent conversation.
・ Empowers to direct reports/organizations to allow staff to act speedy, agility and accountability.
・ Acts to help his/her organizations to make global-wi ide decision-making, which makes balance between short-term performance and long-term vision.

免許・資格

普通自動車第一種運転免許

語学力

給与

年俸制
当社社内規定準じる

雇用形態

正社員

勤務地

東京都

通勤交通費

全額支給

休日

土、日、祝日、会社規定
年間休日122日

福利厚生

各種社会保険完備

この案件に似た求人もご紹介できます

この求人に応募

企業情報

事業内容

■総合医療・健康関連用品の輸入・製造販売

業種分類

医療機器、素材・化学・バイオ・医薬品

あなたにぴったりの求人をご案内します

職種
業種
絞り込み条件を設定する
勤務地
年収
キーワード
職種
業種
勤務地
  • 北海道
  • 東北
  • 関東
  • 北信越
  • 東海
  • 関西
  • 中国・四国
  • 九州・沖縄
  • 海外
年収
キーワード

最新の求人から
貴方に最適なものをご紹介

正社員転職サポートエントリー 無料

求人を探す
  • U・Iターン転職サポート
  • 履歴書・職務経歴書の書き方
  • MyStyle ~ワタシらしく働く~ 女性の活躍・両立支援
  • 障がい者就職支援 多くの方々に就業機会を提供いたします!