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. This position requires strong leadership in study concept development, protocol design, and the ability to work collaboratively with both internal teams and external clients.
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.
The Application ProcessOnce 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 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.
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