Clinical Pharmacologist
BioSpace · Shanghai
Job description
About the role
AbbVie is looking for a Clinical Pharmacologist to lead the China clinical pharmacology strategy, ensuring smooth opening of late‑phase studies and successful regulatory submissions. The role bridges Chinese regulatory requirements with global study teams and provides scientific input for drug development.
Key responsibilities
- Develop and execute China clinical pharmacology strategy covering intensive PK, popPK, PK/PD, exposure‑response, immunogenicity and QT analyses.
- Support opening of late‑phase studies in China and fulfill CP regulatory requirements for NDA registration.
- Represent clinical pharmacology in China AST/IEST, TARM meetings and global study teams.
- Collaborate with global CP counterparts to exchange information and provide Chinese regulatory and scientific input.
- Review and contribute to CP documents for CTA and NDA submissions, including protocols, reports, and briefing materials.
- Participate in CDE consultation meetings and ensure regulatory requirements are addressed.
- Manage relationships with local KOLs 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 experience in clinical pharmacology with a PhD or 4+ years with a Master’s degree in an industry setting.
- Strong interpersonal and communication skills in English (written and spoken).
- Experience working in multinational companies is preferred.
- Ability to think strategically and interact with internal and external stakeholders.
Required skills
- Pharmacokinetics (PK) analysis
- Population PK (popPK) modeling
- PK/PD modeling
- Exposure‑Response analysis
- Immunogenicity assessment
- QT interval analysis
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BioSpace
Shanghai