Job Description 【職務内容】 ● CP2グループの責任者として、臨床薬理・ファーマコメトリクスの専門性を活かし、医薬品の開発戦略、臨床試験デザイン、用法・用量選択および承認戦略を科学的にリードする ● PK、PK-PD、Population PK、Exposure-Response、PBPK等のModeling & Simulation（M&S）を適切に活用し、Model-Informed Drug Developmentを推進する ● PMDA相談、承認申請、照会事項対応、電子データ申請等において、臨床薬理・ファーマコメトリクス領域をリードする ● HQを含むGlobal stakeholderと継続的かつ建設的なscientific discussionを行い、Global development strategyとJapan strategyをつなぎ、日本からGlobal developmentへ貢献する ● CP2メンバーのPeople Managerとして、業務・リソース・優先順位を適切にマネジメントするとともに、coaching、feedback、mentoring等を通じてメンバーの成長とキャリア開発を支援する ● オープンな対話、constructive challenge、knowledge sharingを促進し、多様なメンバーが専門性を発揮できるチーム環境を構築する ● CP2の中長期的なcapability向上を推進し、Clinical Pharmacology / Pharmacometrics領域における次世代人材の育成と組織力強化をリードする【応募要件（必須）】生命科学、薬学、医学、Pharmacometrics等の関連分野における博士号（PhD）製薬企業等における臨床薬理または関連領域での十分な実務経験（10年以上） Clinical Pharmacology、PK/PK-PD、M&S（Population PK、Exposure-Response等）および非臨床ADMEに関する知識・理解 People Managerまたはそれに準ずるLeadership経験、およびメンバーの育成経験 HQを含む海外stakeholderと科学的議論、提案、合意形成を行える英語コミュニケーション能力 Population PK、PK-PD、Exposure-Response、PBPK等のM&Sを自ら実施、またはscientific oversightした経験 PMDA相談、承認申請、CTD作成、照会事項対応、電子データ申請等の経験【歓迎（尚可）】 Global development teamにおいてClinical Pharmacology / Pharmacometrics strategyをリードした経験部門・専門領域を越えてstakeholderを巻き込み、組織横断的に課題解決・意思決定を推進するLeadership 組織のcapability building、talent development、succession planningを推進した経験新しいM&S methodology、technology、AI/data science等を導入し、業務プロセスを改善した経験 Additional location(s) Compensation Information: Required Skills: Biomarker Development, Clinical Study Design, Clinical Trial Development, Clinical Trials Marketing, Ethical Compliance, Ethical Standards, Immuno-Oncology, New Technology Integration, Patient Care, People Management, Pharmaceutical Development, Professional Networking, Protocol Development, Scientific Writing, Strategic Thinking Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 12/1/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

R&D Clinical Pharmacokinetics & Pharmacometrics Prin. Scientist.

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