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ClinChoice
Data Science & Analytics 1d ago

Principal Pharmacokinetics Scientist

ClinChoice
United StatesUnited States
Full-time
Not Disclosed
Senior-Level

Job Description

Key Skills Required

Master these to land this role

R/R StudioModeling & SimulationData ScientistPharmacodynamicsPharmacokinetics

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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 Principal Pharmacokinetics Scientist to join our in-house team and support projects across a diverse client portfolio, including pharmaceutical, biotechnology, medical device, and consumer health companies of varying sizes.

Join our team: you can be part of making a difference in people's 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:

  • A 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.
  • A 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, 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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ClinChoice is a leading global Clinical Research Organization (CRO) dedicated to accelerating the development and commercialization of innovative drugs, medical devices, and diagnostics. Founded in 1995 and headquartered in Horsham, Pennsylvania, the company operates with a massive global footprint, boasting over 3,000 clinical experts across the Americas, Europe, and Asia. Under the hood, ClinChoice delivers end-to-end full-service and Functional Service Provider (FSP) solutions—spanning clinical operations, biometrics, regulatory affairs, and post-marketing safety. Their primary target audience includes emerging and mid-sized biotech startups, as well as top-tier global pharmaceutical giants (partnering with 6 of the top 10 pharma companies globally). What sets ClinChoice apart in the highly regulated life sciences sector is its deep therapeutic expertise and tech-enabled delivery model, having successfully supported over 3,000 clinical studies and 10,000 regulatory submissions worldwide to bring life-saving treatments to market faster.

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