Clinical Scientist, Late Development Oncology

外資製薬メーカーにてオンコロジーー領域におけるクリニカルサイエンティストとして担う

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 important responsibilities include:
・PMDA/MHLW interaction: Co-develop the documents for regulatory interactions such as BD for regulatory consultation, query responses, Sakigake application, ODD application, etc, as a clinical development expert through collaboration Project Physician.
・JNDA: Lead JNDA clinical satellite team activities and be point of contact to JNDA Lead and global CPT.
・KEE management: Act as a key point of contact for clinical development related relationship with external experts.
・The measure of success includes: 1) The quality and quantity of medical/clinical deliverables mentioned above for ensures patients access to valuable medicines. and 2) Leadership and appropriate behaviors.

応募条件

【必須事項】

・Life Science related bachelor’s degree
・Experience of working on drug development in pharmaceutical industry
・Experience of working Oncology TA in pharmaceutical industry

スキル：
・Assertive communication skill
・Business English
・Logical thinking skill
・Leadership capability
・Rapid adaptability to a new environment

語学力：
日本語 Japanese：Native level
英語 English：Business English (英語でのBusiness discussion可能なレベル）TOEIC700点以上

【歓迎経験】

・Doctor of Philosophy
・ 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

スキル：
・Medical writing skill
・Project management skill
・Strategic influencing skill
・Conceptual thinking skill
・Negotiation skill
・Ability to work in a complex, business critical and high-profile environment building credibility in ambiguous situations

【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

通常（実質労働時間との連動）
就業時間：00:00 ～ 00:00

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