Job Description

Resonsible China Clinical Pharmacology strategy (including intensive PK, popPK, PK/PD, E-R, Immunogencitiy and QT analysis) to ensure: 1) smooth opening of late phase study in China; 2) relevant China CP regulation is fullfilled for a successful NDA registration
Serves as the clinical pharmacology representative in assigned China ASTs/IEST and TARM meetings
Serves as the (China) clinical pharmacology representative in assigned (global) study teams, to faciliate study execution
Work closely with related asset global Clin Pharm representatives in timely exchanging the relevant information and provide advise/input from the Chinese regulatory and scientific perspectives to support asset China CP strategy and study execution
Serves as the subject of expert of CP in China with close connection with global CP for professional support and collaboration
A critical reviewer and contributor for China CP documents for CTA and NDA submission, such as China PK study protocol/report/summary, related population PK report, exposure/response analysis report etc.
A key contributor/reviewer for CP part of local CDE consultation related documents (e.g. briefing book, CDE response letter), and CP part of CTA and NDA submission document (e.g. China specific clinical overview, IB and CTD, dose justification, study design justfication/China development plan).
Participate in local CDE consultation meetings and facilitate CP related communication with regulatory agency
Scienficly interpret CDE’s CP requirement in e.g. pre-CTA response, CTA letter, query/deficiency letter during NDA (working together with RA, CPPM and CD), ensure CDE’s requirement is implemented/fulfilled to derisk for regulatory activities.
Mangement of local KOLs
Manage related communications and collaborations between China AST and global AST/IEST in collaboration with the global CP counterparts
Deliver clinical pharmacology related knowledge to multi-functional teams to ensure CP deliverables
Streamline clinical pharmacology related prcess to ensure CP deliverables
Review clinical pharmacolgy guideline and provide comments to draft guidelines

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AbbVie is hiring a

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