Description de l'offre
The field of responsibilities comprises the support of projects through specific pharmacokinetic expertise in a team-oriented way of working within the drug development process (predominantly biologics) at Sanofi.
You develop the PK and/or PK/PD parts of study protocols for preclinical and clinical studies, and you monitor the conduct of these trials. The analyses of the PK and/or PK/PD data in line with regulatory requirements are performed by yourself or under your supervision. In addition, you provide an assessment of the results and perform meta-analyses across studies. Furthermore, you develop modeling and simulation strategies for the projects. Finally, you leverage the preparation of regulatory documents by providing your PK expertise.
You foster and steer translational and quantitative pharmacology aspects throughout the drug development process.
As a project team member, you are permanently monitoring timeline adherence and you are representing PKDM (Pharmacokinetics, Dynamics and Metabolism) in interdisciplinary teams in all aspects. In addition, you are leading project-supporting groups.
Your work in the drug development process will take place in close interdisciplinary collaboration with colleagues within other internal functions (e.g. clinics, pharmacology, CMC), as well as with external partners or regulatory agencies.
· PhD or MD degree in natural sciences or medicine with a focus on PK.
· Experience in the clinical drug development, including the pharmacokinetic/statistical analysis of clinical data with common software packages (e.g. WinNonlin/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.
· Excellent communication skills for a highly effective teamwork within multidisciplinary, local and international teams are required.
· Highly effective verbal and written communication and presentation skills in English are essential.
· An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
· An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
· An individual and well-structured introduction and training of new employees.
· You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
· As a globally successful and constantly growing company, Sanofi provides international career paths as well.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.