Clinical Pharmacology, Modeling and Simulation

7 days ago

Billerica MA United States Parexel International Corporation Full time
Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globallyWe currently havetremendous opportunities available to join this extremely collaborative and super friendly team If you're looking for an opportunity to expand professionally, do more than a narrow scope of work, work alongside a large team of CPMS experts, and provide solutions to a variety of clients with various products in different stages of development across multiple therapeutic areas, we would love to connectWe are currently seeking highly experienced and highly innovativeClinical Pharmacology Modeling and Simulation (CPMS)professionalsto join our team and help our clients reduce the time to bring new treatments to patients.We currently have the following home-based opportunities available in the US and Canada:
  • Associate Director, CPMS
  • Director, CPMS
  • Senior Director, CPMSAnd the following roles in our other global locations:
    • PK Scientists
    • Senior PK Scientists
    • Associate Director, CPMS
    • Director, CPMS
    • Senior Director, CPMSQualifications:
      • Depth of experience and relevant experience will determine level of role.
      • Excellent written and verbal English communication skills are required. Chinese language skills are a plus.
      • Advanced science degree (PhD, PharmD, MSc) and/or relevant experience
      • Significant experience in clinical drug development of both NCEs and biologicals
      • Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectations
      • Experience using Phoenix WinNonlin to conduct non-compartmental and compartmental analysis.
      • Experience using other software such as NONMEM, GastroPlus or R are desirable.
      • Strong non-compartmental analysis experience
      • Previous popPK and/or PBPK experience are a plus.
      • Excellent interpersonal, verbal and written communication skills
      • Extensive clinical/scientific writing skills
      • Client focused approach to work ethic.
      • Exhibits and promotes a flexible attitude with respect to work assignments and new learning.
      • Ability to direct and manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
      • Willingness to work in a matrix environment and to value and promote the importance of teamwork.
      • Demonstrated understanding of the drug development process and a broad knowledge of FDA and EMEA guidelines, as well as global regulatory expectationsKnowledge And Experience
        • Significant experience with application of clinical pharmacology, modeling and simulation in drug development and clinical trial conduct in pharmaceutical industry, CRO or academia desired
        • Acknowledged as an expert in the industry for more senior roles.
        • Demonstrated knowledge of regulatory environment as it relates to CPMS and Drug DevelopmentQualified candidates who are seeking full-time or part-time employment will be considered in any of the 41 countries where Parexel has operations.
          #LI-REMOTE

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