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Senior/Principal Pharmacokinetics Scientist - (Fulltime-Remote)

Pharmiweb
Jersey, NJ Remote Full Time
POSTED ON 1/17/2025
AVAILABLE BEFORE 4/16/2025

Senior / Principal Pharmacokinetics Scientist - (Fulltime-Remote)

at ClinChoice (View all jobs)

United States

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Senior / Principal Pharmacokinetics Scientist in the United States. The ideal candidate will possess a deep understanding of pharmacokinetics (PK) and pharmacodynamics (PD) theory and practice and will play a key role in the design, execution, and analysis of clinical pharmacology studies and other projects involving PK / PD. This position requires strong leadership in study concept development, protocol design, and the ability to work collaboratively with both internal teams and external clients.

Join our team : you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!

Key Responsibilities :

  • Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and creating modeling and simulation plans.
  • Conduct PK-PD, Pop PK-PD, and related analyses to support clinical trials, ensuring accurate data interpretation and integration into regulatory filings, clinical publications, and presentations.
  • Provide technical expertise and support in the use of standard PK and PD data analysis software, including Phoenix WinNonlin, NLME, R / R Studio, Monolix, NONMEM, and similar tools.
  • Collaborate closely with clients to understand project needs, provide expert guidance on clinical pharmacology, and deliver high-quality outcomes.
  • Prepare and review comprehensive PK / PD analysis reports, ensuring clear and precise communication of study results to clients and stakeholders.
  • Apply significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology to ensure compliance and support regulatory submissions.
  • Work effectively in cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations, to ensure seamless project execution.
  • Provide mentorship and leadership to junior pharmacologists, contributing to the development and implementation of best practices within the team.
  • Stay current with advancements in clinical pharmacology, applying the latest knowledge to enhance project outcomes and client satisfaction.

Qualifications :

  • PhD in pharmaceutical sciences, pharmacology, life sciences, clinical pharmacology, pharmacokinetics, or a related discipline, with at least 3 years of relevant research or clinical experience in clinical pharmacology and pharmacokinetic-pharmacodynamic modeling within the pharmaceutical or biotechnology industry.
  • PharmD in a relevant discipline with a minimum of 5 years of experience in clinical pharmacology and PK / PD modeling and simulation.
  • Alternatively, a Master’s degree in a related field with at least 7 years of relevant experience in Clinical Pharmacology and Modeling & Simulation.
  • Robust knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK / PD data analysis.
  • Hands-on experience and expertise with standard PK and PD data analysis software such as Phoenix WinNonlin, NLME, R / R Studio, Monolix, and NONMEM.
  • Strong communication and organizational skills, with the ability to present complex data to both scientific and non-scientific audiences.
  • Proven ability to manage multiple projects simultaneously and work effectively in a dynamic, client-oriented environment.
  • Preferred Qualifications :

  • Experience in working across a variety of therapeutic areas.
  • Prior experience working in a CRO setting is highly desirable.
  • Relevant certifications in clinical pharmacology or related disciplines are a plus.
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