Clinical Science

【求人No NJB2333851】
承認および承認後の臨床プログラムを統括し、戦略立案やリスク評価をリードします。臨床試験の設計・実施・管理を担い、規制承認や市場アクセスを支援。国内外の関係者と連携し、高品質な臨床文書作成や安全性評価を行います。医療・科学的専門知識を活かし、チーム育成やプロセス改善にも貢献し、製品価値最大化を目指します。

■Education
・ Advanced degree in life sciences/healthcare （or clinically・relevant degree: MD or equivalent PhD PharmD degree is・preferable） required.Specialization in a subspecialty may be needed. Advanced・clinical training/knowledge in medical/ scientific area・aligned with TA required.

■Experience/Professional・requirement
: ・5 years of involvement in clinical research or drugdevelopment in an industry environment spanning clinical・activities in Phases I through III/IV including submission・dossiers （In case MD holder equivalent medical experience・is needed）
・ Advanced knowledge of assigned therapeutic area・required with the capability to innovate in clinical・development study designs that provide relevant evidence・to decision makers and to interpret discuss and present・clinical trial or section program level data
・ Thorough knowledge of GCP and GPSP clinical trial design ・statistics and regulatory/clinical development process
・ Experience with submissions and health authorities required・ Demonstrated ability to establish strong scientific・partnership with key stakeholders
・ Demonstrated leadership and team management skills・with a documented track record of delivering high quality・projects/submissions/trials in pharmaceutical or biotech・industry・ Considerable organizational awareness including extensiveexperience working cross functionally and in clinical teams
・ Excellent management interpersonal communication （both・written and oral） and problem solving skills・ Excellent negotiation and diplomatic skills・

■English Skill:
・ Fluent oral and written English