中文

Position Title:Senior Principal Scientist / Principal Scientist / Clinical Pharmacologist
Department:Clinical Pharmacology
Location:Shanghai

Position Summary

As a clinical pharmacologist, you will play a key role in PK/PD sciences including clinical trial study design, PK analysis, results reporting and implementation of a modeling and simulation plan that conforms with best practices.


Key Responsibilities

  • Serves as scientific lead to provides expertise on designated clinical programs and studies for various therapeutic areas.
  • Study design and protocol development for various studies, such as dose selection for the first in human study, BA/BE, biosimilar, drug-drug interaction, special populations etc.

  • Review CRF
  • Data analysis plan preparation and TLF design
  • Independently perform and review PK/PD analyses.
  • Non-compartment PK/PD analysis
  • Compartment PK/PD analysis, modeling and simulation
  • Responsible for ensuring appropriate summary and interpreting results of PK/PD analyses with respect to their impact on development of study drugs
  • Ensure working process following good practice of study requirement and SOPs.
  • Establish scientific credibility inside and outside the company (e.g., abstracts, posters, podium presentation at conferences)
  • Provide project management of the clinical pharmacology projects, or play a key role in projects delivery and guidance
  • May involve in junior member training, coaching, and mentoring

  • Education and Key Competency Requirements
    Professional Experience and Education Requirements

  • Master in Pharmaceutical Sciences, Pharmacology, biochemistry, Toxicology, Statistics, Mathematics, Bioengineering, or related discipline. Ph.D. or Pharm.D. is preferred.
  • Generally, 5 or more years in clinical pharmacology or related experience
  • Working knowledge of China, US, European, or other countries / regions regulatory requirements and guidelines
  • Must be proficient with at least one modeling and simulation software such as Phoenix WinNonlin, NONMEM etc.
  • Demonstrated understanding of model-based drug develop principles and tools as well as ability to apply these tools

  • Key Competency Requirement

  • Ability to think critically and scientifically
  • Strong industry/academic/consulting experience in PK analysis and modeling and simulation skills
  • Ability to interpret PK and PD results, author report sections, and prepare presentations to illustrate findings
  • Strong organizational, interpersonal, self-motivation, and high personal integrity
  • Proficient in spoken and written English
  • Ability to communicate professionally and courteously with clients
  • Well-developed of time management, communication, presentation, analytical and interpersonal skills
  • Proactively seeks out process improvements, efficiencies, and innovations
  • Continuous learning capability
  • Excellent team player and team leader skills
  • Apply for the position
    Submit

    China:
    298 Xiangke Road, 3/F, 301-305, Zhangjiang Hi-Tech Park, Pudong, Shanghai 201210, China
    Tel: +86 21 5090 0085 Fax: +86 21 6875 5515
    US:
    261 Madison Avenue, 24th fl. New York, NY 10016 US
    Phone: +1-212-681-2100
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