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Manager, Non－clinical Pharmacology | Non－line manager | R＆D Alliance, Kobe Pharma Research Institute

年収： 900万～ 1100万

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部署・役職名	Manager, Non－clinical Pharmacology \| Non－line manager \| R＆D Alliance, Kobe Pharma Research Institute
職種	非臨床研究
業種	電気・電子医薬品メーカー
勤務地	兵庫県
仕事内容	Basic Purpose of the job: Prepare and finalize non-clinical pharmacology documents for PMDA submission. Be representative for key interactions with PMDA in terms of non-clinical pharmacology, aiming for commercial success of Boehringer's products Make value propositions for all New Molecular Entities (NMEs) in the Japanese market from a biopharmaceutical perspective Accountabilities - Related Performance Indicators: Understand Global Master Dossier for each NME and prepare its Japanese version of non-clinical section to fit the local requirement, and to address unmet medical needs clearly ・Development of strategic plan for Japanese version preperation to differentiate the product (e.g. additional data, wordings, etc) ・Implementation documentation/review process with well alignment with overall J-NDA submission timeline ・Finalize non-clinical pharmacology section for each submission in timely manner Make value propositions for NME in the Japanese market from a biopharmaceutical perspective in collaboration with MAHA: ・Deep understanding of competitive landscape and SoC in the field ・Alignment with MAHA interms of pricing strategy ・Preparation of non-clincal paharmacology section of the pricing claims to clarify key differentiators of NME from competitors as well as from SoC in line with the pricing strategy Act as the interface between Japan team and Global Discovery Research (non-clinical pharmacology group) ・Communicate with the non-clinical pharmacology group for each project to obtain sufficient infromation and data, which are not included in GMD, to strengthen value proposition ・Keep Japan team updated in terms of non-clinical feature of the project Propose and plan non-clincal studies for NMEs that create meaningful differentiation from competitors and SoC ・Identify key differentiators of NME during early clinical phase ・Propose non-clinical studies if similar studies have not been conducted in house in timely manner ・Plan and lead the studies if applicable Actively participate Development Japan Interfaces: Project management, Clinical operation, Non-clinical pharmacokinetics, Non-clinical toxicology, Non-clinical analytics
労働条件	契約期間：期間の定めなし試用期間：あり（3カ月）就業時間：8:45～17:20（うち休憩45分間）休日：土日、祝日　その他各種会社休日あり（年間127日：2025年）休暇：年次有給休暇（入社初日に6～16日を付与）、慶弔休暇・リフレッシュ休暇等各種有休特別休暇制度あり残業：あり給与改定：年1回（4月）通勤手当：会社規定に基づき支給社会保険：健康保険、厚生年金、労災保険、雇用保険就業場所：神戸
応募資格	【必須（MUST）】 Required Education: Doctoral Degree eg. PhD or MD　博士修了 Biology　生物学 Pharmacology Required Capabilities (Skills, Experiences, Competencies): Special Skills • Proven track records in regulatory science activites in non-clinical pharmacology • High communication skills in English / Japanese, especially in conflicted situation • Strategic thinking • Knowledge of regulatory related laws and guidelines in drug development Language Skills & Proficiency: Japanese: Native/Fluent English: Native/Fluent Requires Experience: International Experience: Int'l exposure in daily business (>50%of international business / customers / staff) > 1.5 years ～ 4 years Special Work Experience • > 5 years experiences of working for pharmaceutical R&D (ideally international pharma) • Proven performance record of working in the field of responsibility (>10 drug development projects) • Good connection with academia and authorities
アピールポイント	Uターン・Iターン歓迎完全土日休みフレックスタイム
リモートワーク	可「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策	屋内禁煙
更新日	2026/07/03
求人番号	8889527

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日本ベーリンガーインゲルハイム株式会社

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