Clinical Pharmacologist – China Clinical Pharmacology Strategy

About the role

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

Key responsibilities

• Develop and execute China clinical pharmacology strategy, covering intensive PK, population PK, PK/PD, exposure‑response, immunogenicity and QT analyses.
• Represent clinical pharmacology in China AST/IEST and TARM meetings and in global study teams.
• Collaborate with global clinical pharmacology counterparts to exchange data and provide Chinese regulatory and scientific input.
• Act as the subject‑matter expert for clinical pharmacology in China, supporting global partners.
• Review and contribute to China CP documents for CTA and NDA submissions, including protocols, reports, population PK analyses, and exposure‑response assessments.
• Prepare and review CP sections of CDE consultation materials and facilitate communication with regulatory agencies.
• Interpret CDE requirements, ensure implementation in regulatory filings, and manage local KOL relationships.

Required profile

• Master’s degree or higher in pharmacy, pharmacology, biology, medicine or related field; PhD preferred.
• 0+ years of industry clinical pharmacology experience with a PhD, or 4+ years with a Master’s degree.
• Strong interpersonal skills and ability to work with internal and external stakeholders.
• Strategic thinking capability and high proficiency in written and spoken English.
• Experience in multinational pharmaceutical companies is a plus.

Required skills

• Intensive pharmacokinetic (PK) analysis
• Population PK (popPK) modeling
• PK/PD and exposure‑response (E‑R) analysis
• Immunogenicity assessment
• QT interval analysis
• Clinical pharmacology regulatory submissions (CTA, NDA)
• Chinese regulatory (CDE) processes and documentation