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R&D Clinical Pharmacokinetics & Pharmacometrics Prin. Scientist

Merck470 open roles

Where
JPN - Tokyo - Chiyoda
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Hybrid
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Your applicationOpen nowR&D Clinical Pharmacokinetics & Pharmacometrics Prin. ScientistMerck · JPN - Tokyo - Chiyoda
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The clock on this job

Early applications get read.

13.3% of postings close within 7 days. Measured by our own scanner across the market. Merck postings stay open a median of 18 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.6%3 days
  3. 13.3%7 days
  4. 21.3%14 days
  5. 35.7%30 days
  6. 59.1%60 days
This job: posted today

Merck median: 18 days open

The posting

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:

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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

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VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

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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.

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