オンコロジー領域クリニカルディベロップメント【アソシエイトディレクター】の転職・求人情報 22573340

募集要項

仕事内容: 多数の革新的な製品を有する外資系バイオ製薬会社で、オンコロジー領域のクリニカルディベロップメント【アソシエイトディレクター】職を募集いたします！
オンコロジー領域経験は不問です。
Reporting to the Therapeutic Area Lead of Clinical Development Japan, the person in this position plays an integral role in the scientific planning, execution and reporting of clinical studies in Japan for our development compounds. Although generally assigned to a specific therapeutic area, the person in this position may support local clinical research activities across development programs.
The key activitiesinclude the following:
●Clinical Study
・Collaborate with Clinical Development in the US headquarters to develop and/or review study designs and protocol synopses.
・Author and/or review the clinical sections of study materials, CTN and briefing document for PMDA meeting.
●Key Opinion Leader (KOL) Engagement
●JNDA
●Publication
●Research Collaboration & Business Development
●When assigned as a Project Lead, leads the following project tasks
Track the progress and problems of development projects in Japan, and work with team members to solve problems.

応募資格

必須: ・理系修士卒以上
・Minimum of 7 years within clinical research or related activities.
・Cutting edge expertise in assigned therapeutic area.
・開発戦略経験
・新薬申請経験（J-NDA）
・プロトコル作成、ポートフォリオ戦略力の高い方
※オンコロジー領域のご経験は不問ですが、オンコロジー経験者の方は歓迎。
・英語上級レベル
・Communication skills including in English to collaborate with the relevant functions in the US Headquarters and the Japanese affiliate toward common goals and to share information in a timely manner.
・Scientific thinking and Medical Writing skills capable of authoring clinical study protocols, clinical sections of JNDA dossier and scientific manuscripts.
・Skills for comprehension and presentation of scientific data
・Knowledge of statistical analysis to understand the statistical data.
・Knowledge of clinical guidelines and related regulations in Japan, the US, and Europe.

歓迎: ・Advanced degree (i.e. MD, PharmD/Pharm.M, PhD) preferred and with industry experience.

フィットする人物像: ・Leadership and desirably project management skills to lead clinical development of new drugs.
・Logical thinking and problem-solving skills to analyze the root cause of the problem and develop and implement countermeasures.
・Skills for negotiation with regulatory authorities and investigators to facilitate clinical trials and JNDA reviews.
・Thinking and application ability of clinical development to formulate the optimal and expeditious development strategy in Japan with mindset to think globally and to act locally.

休日休暇: 完全週休2日制（休日は土日祝日）、年間有給休暇12日～20日（下限日数は、入社直後の付与日数となります）
年間休日日数125日、年末年始休暇、グローバル休暇、有給休暇は初年度は入社日により最大12日付与、傷病休暇

事業内容・会社の特長: 医療用医薬品の製造・販売など

多数の革新的な製品を創出している外資系バイオ製薬会社
アンメット・メディカル・ニーズのある分野で医薬品を提供することにより、世界中の患者さんの治療を前進させることを目指しています。
当社は25種類以上の革新的な医薬品を製品化し、HIV、ウイルス性肝炎、がんなどの疾患を抱える人々の治療に変革をもたらしてきました。