Clinical Pharmacologist (China)
AbbVie · Shanghai
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.
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Published 1 month ago
Expires 2 weeks from now
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AbbVie
Shanghai