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AbbVie is hiring a Clinical Pharmacologist

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Shanghai, Shanghai
Posted 10 days ago
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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

Skills & Technologies

Clinical PharmacologyPK/PD AnalysisPopulation PK (popPK)Exposure-Response (E-R) AnalysisRegulatory Knowledge (CDE, NDA, CTA)Data AnalysisRPythonMATLABClinical Research
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Salary Information

Salary: $120000-180000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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