Stellenbeschreibung - Clinical Expert Pharmacokinetics - all genders
connecticum Job 1584947 / R2662537
About the job
The Clinical Pharmacokinetics teams at Sanofi play an integral role in streamlining the development of innovative medicines in different therapeutic areas. We achieve this by developing M&S strategies and driving PK and PK/PD assessments in clinical studies. We have an exciting opportunity for a Senior Expert in Clinical Pharmacokinetics to join the team in Germany.
Develop modeling and simulation strategies for projects including translational and quantitative pharmacology aspects
Develop PK and/or PK/PD parts of study protocols for preclinical and clinical studies and monitor the conduct of these trials.
Analyze PK and/or PK/PD data in line with regulatory requirements either by yourself or under your supervision.
Provide your in-depth PK expertise in the preparation of regulatory documents and significant interactions with regulatory agencies.
Lead project-supporting groups and work in close collaboration with colleagues from different internal departments as well as with external partners or regulatory agencies.
Education and professional Experience
PhD or MD degree in natural sciences or medicine with a focus on PK and PK/PD.
Excellent oral and written communication skills.
The ability to present and discuss technical information with other stakeholders with less technical experience.
Passion and enthusiasm to work in a multi-disciplinary team within a global setting, and to ensure the timely delivery of required scientific input needed to make a remarkable impact on patients’ lives.
Experience in the clinical drug development, including the pharmacokinetic/statistical analysis of clinical data with common software packages (e.g. Phoenix).
Relevant software experience in physiology-based PK modelling (preferably PK-Sim or SimCyp), and population modeling for analyzing PK/PD data (NonMem, R) would be of advantage.