Clinical Expert Pharmacokinetics - all genders

About the job

Our Team:

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.

Main responsibilities:

• 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.

 
About you

Education and professional Experience

• PhD or MD degree in natural sciences or medicine with a focus on PK and PK/PD.

Soft skills

• 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.

 
Technical skills

• 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.

 
Languages

• English is a prerequisite; German is a plus.