Scientifique PK/PD
VITRY SUR SEINE
il y a 1 jour
About the Job
Excelya is seeking a skilled Pharmacokineticist to join our dynamic team. You will play a key role in supporting the pharmacokinetic (PK) evaluation of clinical trials across all phases, contributing to drug development and regulatory submissions. The consultant will contribute to pharmacokinetics (PK) activities across Phase I to Phase III clinical trials , ensuring the timely delivery of high‑quality PK analyses, interpretations, and documentation.
Key Responsibilities
- Contribute to the definition and implementation of PK strategies across clinical studies.
- Write and review pharmacokinetic sections of clinical study protocols.
- Support study set‑up, conduct, and follow‑up from a PK perspective.
- Perform pharmacokinetic analyses , primarily using Non‑Compartmental Analysis (NCA) .
- Interpret preliminary and final PK data and translate results into clear conclusions.
- Present PK results during internal project team meetings .
- Contribute to Clinical Study Reports (CSR) and/or standalone PK reports .
- Collaborate with cross‑functional teams including Clinical Operations, Biostatistics, and Data Management.
- Ensure all PK activities are delivered in line with study timelines and quality standards.
Qualifications and Experience
- Advanced degree (MSc or PhD) in Pharmacokinetics, Pharmacology, Pharmaceutics, or related field.
- Proven experience in pharmacokinetic data analysis, preferably within clinical drug development.
- Proficiency with PK analysis software such as Phoenix WinNonlin.
- Familiarity with PK/PD modeling and statistical programming languages (R, SAS) is a plus.
- Strong analytical, organizational, and communication skills.
- Fluency in English.
Entreprise
Excelya Group
Plateforme de publication
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