A Global Biopharmaceutical company who specialise in the development of therapies for neurological and autoimmune diseases are growing their Pharmacometrics team. This growth is caused by the need to meet the increasing volume of clinical trials. Along with their drive to continue to improve their capabilities as a Group as they continue to remain at the cutting edge of the sector.
There are two opportunities available within the team as a Lead Pharmacometrician and a summary of the responsibilities is:
- Responsibility for leading & delivering the Pharmacometrics strategy to support their assets across all phases of clinical trials.
- Including extrapolation, dose selection, trial design, PIP development and ongoing evaluation as data is generated.
- Performing simulations for PBPK, QSP, and clinical trilas for your assigned projects.
- Convert the analysis of PBPK & QSP analysis into actionable insights. Then communicate these to stakeholders and project teams.
- Develop the Pharmacometrics analysis of plans & reports to be used for projects that are submission ready.
- As a senior member of the team you will support the development of team from a technical & scientific perspective. With the purpose to ensure state of the art mechanistic approaches are used to optimise drug discovery & development.
- Have a working knowledge of regulatory pathways on a global basis to seek opportunities for collaboration with health authorities in relevant disease areas.
As a Lead Pharmacometrician you will report directly to the Global Head and work closely with QCP leads. This is a very visible position which influences the integration of pharmacometrics aspects of the programmes.
For this position you will need to have:
- PhD or MD in Pharmaceutical Sciences, Statistics, or related area.
- With experience in PBPK and QSP modelling in the Biotech / Biopharmaceutical / Pharmaceutical sectors.
- Experience in the use of relevant software such as PK- Sim / Mobi / SimCyp. If you have direct experience with NONMEM and / or Python that is an advantage.
- Strong communication skills and working in a fast paced & dynamic environment.
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