【1400～2000万円】Director Clinical Pharmacology

【求人No NJB2352009】
日本の規制当局対応を中心に、国内外の臨床薬理活動を科学的かつ規制面でリードします。
PK/PD評価や日本特有の規制要件に基づくフェーズI試験の設計支援、非臨床データの解釈、規制当局との交渉資料作成を担当。グローバルチームと密接に連携し、日本の規制要件を反映した開発計画を推進します。CRO管理や関連文書作成も担い、幅広い分子種の経験を活かして臨床薬理活動を統括。国内外の関係者と協働し、科学的整合性と規制対応の一体化を図ります。

■Experience / Knowledge
10+ years of experience in clinical pharmacology or PK/PD roles within the pharmaceutical industry PMDA or equivalent institutions.
Deep understanding of:
PK/PD principles
Japan specific clinical pharmacology data requirements
Japanese Phase I data requirements
Regulatory expectations for Phase I designs involving healthy Japanese subjects
Nonclinical PK/ADME interpretation and nonclinical・clinical bridging concepts
Experience preparing PMDA consultation materials and scientific justification packages.
Experience with CTD clinical pharmacology modules.
Demonstrated experience with both small and large molecule modalities （e.g. AAV antibodies protein therapeutics） is required to effectively support the Insmed portfolio as the sole CP representative in Japan.

■Skills / Capabilities
Strong PK/PD analytical and scientific communication skills
Ability to clearly explain CP and regulatory concepts to global stakeholders
High autonomy and flexibility
Strong cross functional and global teamwork skills
CRO/vendor management experience
Native level proficiency in Japanese is strongly preferred and business level proficiency in both written and spoken Japanese and English is required. The role requires the ability to actively participate in meetings clearly communicate complex concepts and engage in scientific discussions with global and Japan based stakeholders

■Qualifications
Advanced degree （PhD PharmD MS） preferred; bachelor’s with extensive experience considered.

■Travels
Willingness and ability to travel approximately 10% （domestic and international） including overnight travel as required.