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Clinical Pharmacologist (China)

AbbVie · Shanghai

🇬🇧 English
CDE consultation

Job description

About the role

AbbVie is seeking a Clinical Pharmacologist to lead its China clinical pharmacology strategy, ensuring successful study execution and regulatory compliance for late‑phase trials and NDA submissions.

Key responsibilities

  • Develop and implement China clinical pharmacology strategy, including intensive PK, population PK, PK/PD, exposure‑response, immunogenicity and QT analyses.
  • Represent clinical pharmacology in China AST/IEST, TARM, and global study team meetings.
  • Collaborate with global clinical pharmacology partners to provide Chinese regulatory and scientific input.
  • Review and contribute to China CP documents for CTA and NDA submissions, such as protocols, reports, exposure‑response analyses, and briefing books.
  • Lead interactions with the Chinese regulatory agency (CDE), interpreting requirements and ensuring compliance.
  • Manage local key opinion leaders and coordinate communications between China and global teams.

Required profile

  • Master’s degree or higher in pharmacy, pharmacology, biology, medicine or related field; PhD preferred.
  • 0 + years of industry experience with a PhD or ≥ 4 years with a Master’s degree in clinical pharmacology.
  • Strong interpersonal and stakeholder‑management abilities.
  • Strategic thinking and high proficiency in written and spoken English.
  • Experience working in multinational companies is a plus.

Required skills

  • Pharmacokinetics (PK) and population PK (popPK) analysis
  • PK/PD and exposure‑response (E‑R) modeling
  • Immunogenicity and QT interval analysis
  • Clinical pharmacology expertise for regulatory submissions
  • CDE consultation and regulatory document preparation
  • Key opinion leader (KOL) management

What we offer

  • Opportunity to shape clinical pharmacology strategy in a leading global biopharma.
  • Collaboration with international scientific and regulatory teams.
  • Supportive, inclusive work environment.

Questions fréquentes

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Published 1 month ago

Expires 2 weeks from now

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AbbVie

Shanghai