Senior/Principal Pharmacokinetics Scientist
Company
ClinChoice
Location
USA
Type
Full Time
Job Description
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:
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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-pharmacodynamic 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 Master’s 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.
Preferred Qualifications:
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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.
#LI-TT1 #LI-Remote #Senior #Contract
Date Posted
08/16/2024
Views
1
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