Role Description
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. 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.
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Significant experience leading study concept and protocol design, authoring clinical pharmacology development plans, and creating modeling and simulation plans.
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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.
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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.
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Collaborate closely with clients to understand project needs, provide expert guidance on clinical pharmacology, and deliver high-quality outcomes.
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Prepare and review comprehensive PK/PD analysis reports, ensuring clear and precise communication of study results to clients and stakeholders.
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Apply significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology to ensure compliance and support regulatory submissions.
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Work effectively in cross-functional teams, including bioanalytical scientists, biostatisticians, and clinical operations, to ensure seamless project execution.
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Provide mentorship and leadership to junior pharmacologists, contributing to the development and implementation of best practices within the team.
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Stay current with advancements in clinical pharmacology, applying the latest knowledge to enhance project outcomes and client satisfaction.
Qualifications
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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-pharmacynamic modeling within the pharmaceutical or biotechnology industry.
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PharmD in a relevant discipline with a minimum of 5 years of experience in clinical pharmacology and PK/PD modeling and simulation.
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Alternatively, a Masterβs degree in a related field with at least 7 years of relevant experience in Clinical Pharmacology and Modeling & Simulation.
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Robust knowledge of pharmacokinetics, pharmacodynamics, translational sciences, and PK/PD data analysis.
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Hands-on experience and expertise with standard PK and PD data analysis software such as Phoenix WinNonlin, NLME, R/R Studio, Monolix, and NONMEM.
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Strong communication and organizational skills, with the ability to present complex data to both scientific and non-scientific audiences.
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Proven ability to manage multiple projects simultaneously and work effectively in a dynamic, client-oriented environment.
Requirements
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Experience in working across a variety of therapeutic areas.
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Prior experience working in a CRO setting is highly desirable.
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Relevant certifications in clinical pharmacology or related disciplines are a plus.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.