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. 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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