Clinical Scientist(Hematology & Early Development/ Oncology

外資製薬メーカーにてClinical Scientistとして臨床開発のプロジェクトリードを担います

仕事内容

Clinical Scientist (CS) is a clinical project lead with strong experience in multidisciplinary aspects of drug development and is accountable/responsible for generating clinical development strategy, designing clinical development options, and delivering successful clinical development programs for responsible assets in Japan.
His/Her accountability/responsibility is balanced between project-level and study-level activities, depending on his/her experience and expertise, in order to achieve deliveries of both projects and studies.

Other major responsibilities/accountabilities include but are not limited to:
・Co-developing the documents for regulatory interactions such as BD for regulatory consultation, query responses, Sakigake application, ODD application, etc,
・Authoring clinical/medical part of CTD and responses to queries
・Acting as a key point of contact for clinical development related relationship with external experts.
・Leading development of clinical science part of clinical trial documents, and providing support for the Study Level Safety Review activity, for Japanese standalone development projects,
・Inputting to publication strategy and contents/quality of publications.

For more information about responsibilities/accountabilities, refer to the full version of the Job Description for Clinical Scientist

応募条件

【必須事項】

・ライフサイエンス関連の学士号以上
・製薬企業での臨床開発のリードやプロマネ経験を有する方(目安:5年以上)（プロトコル作成までご経験をお持ちの方）

スキル：
・Assertive communication skill
・Medical writing skill
・Business English
・Project management skill
・Logical thinking skill
・Strategic influencing skill
・Leadership capability
・onceptual thinking skill
・ Negotiation skill
・ Ability to work in a complex, business critical and high-profile environment building credibility in ambiguous situations
・Rapid adaptability to a new environment

語学力：
英語 English： Business English
日本語: Native level

【歓迎経験】

・Doctor of Philosophy preferred
・Clinical science strategy planning in drug development
・Negotiations with external experts
・Planning of clinical science strategies as a Japan clinical science representative at the cross-functional team
・ Quality of knowledge on drug development strategy and clinical science
・Experience on negotiation with PMDA/MHLW, and getting JNDA/sJNDA approval and supporting launch activities

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、大阪、東京

転勤の有無

転勤なし

受動喫煙防止措置

敷地内禁煙（喫煙場所なし）

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）

勤務開始日

応相談

休日休暇

年間休日数：125
土日祝
年間有給休暇：入社半年経過時点12日（入社月に応じて4日～最高20日）　 ～ 20日
法定休暇：年次有給休暇、産前産後休暇
その他休暇：リフレッシュ休暇、頭痛休暇他

年収・給与

年収　　600万円～1200万円　経験により応相談

諸手当

住宅手当、通勤手当、単身赴任手当、休日手当ほか

昇給

年１回

賞与

年間標準6ヶ月

採用人数

1名　

待遇・福利厚生

通勤手当：有
確定拠出年金、財形貯蓄制度・持株会制度・慶弔見舞金・健康診断・福利厚生倶楽部ほか

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
退職金制度：有

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接