Pharmacokineticist Expert
About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
As an Operational PK/PD Expert, you will provide operational support to the Global Early Phases Clinical Expert and contribute to the development, registration, and commercialization of products across the portfolio.
Responsibilities include:
- Lead and coordinate PK/PD activities across early-phase clinical programs.
- Oversee outsourced PK/PD studies and manage relationships with external CROs and vendors.
- Ensure the quality, integrity, and regulatory compliance of PK/PD data generated throughout studies.
- Review and contribute to clinical, regulatory, and scientific documentation (e.g., submissions, investigator brochures, briefing books).
- Support the design, execution, and interpretation of pharmacokinetic and pharmacodynamic studies.
- Perform and/or review PK analyses and modeling activities using industry-standard tools.
- Provide scientific expertise on bioavailability, bioequivalence, drug-drug interaction, and bioanalytical topics.
- Ensure studies are conducted in compliance with ICH-GCP, SOPs, and applicable regulatory requirements.
- Collaborate with cross-functional teams to support evidence generation and decision-making.
- Contribute to the delivery of high-quality data suitable for regulatory submissions, publications, and commercial use
Profile
Experience: Proven experience in Pharmacokinetics within the pharmaceutical, consumer healthcare, FMCG, or related industries, Proven experience in the design, execution, and/or management of PK clinical studies, Experience overseeing outsourced studies and managing external CROs or vendors is highly desirable, Exposure to OTC products and clinical evidence generation is a strong advantage.
Skills: Strong expertise in Pharmacokinetics/Pharmacodynamics and PK modeling concepts, Proficiency with pharmacokinetic analysis tools, particularly Phoenix, Solid knowledge of clinical development processes and early-phase clinical research, Good understanding of international regulations and guidelines (ICH-GCP, GMP, bioequivalence, pharmaceutical regulations).
Language: Fluent English, both written and spoken.
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique !
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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