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Senior / Principal Pharmacokinetics Scientist - (Fulltime-Remote)
at ClinChoice (View all jobs)
United States
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 :
- 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 :
Preferred Qualifications :
LI-DNP