US ~ Garnet Valley, PA
Senior PBPK Modelling and Simulation Scientist
Our growing and successful business comprises over 900 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Due to business growth, there is now an exciting opportunity for a scientist specializing in physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) to join the Scientific Consulting Group as a Senior PBPK Modelling and Simulation Scientist.
The Senior PBPK Modelling and Simulation Scientist will provide hands-on M&S scientific support and input throughout a project lifecycle (design, planning, delivery and reporting) to ensure client’s study objectives are achieved.
The successful candidate will work closely with the sponsor and Quotient team to perform the following tasks:
- Develop a thorough understanding of the biopharmaceutic, pharmacokinetic and metabolism profile of assigned compounds.
- Independently build and rigorously test PBPK models to support evaluation of absorption and systemic exposure potential for NCE’s.
- Use in vitro data and in silico tools to predict or describe the impact that formulation strategy/technology can have on in vivo performance.
- Provide in silico simulations to aid interim decision making during clinical studies regarding dose escalation and formulation selection.
- Investigate the existence of correlations between in vitro dissolution data and human plasma concentration-time data (IVIVCs) using either mechanistic models or traditional numerical deconvolution approaches.
In addition, the jobholder will be expected to perform additional support tasks including:
- Provide scientific support to other Quotient departments to effectively communicate Quotient’s M&S capabilities and identify and develop further opportunities.
- Review data packages and generate proposals for potential new projects.
- Train, mentor and support existing and new members of staff, as required to provide scientific background information on biopharmaceutics, formulation development, PK, M&S and DMPK.
- Produce high quality reports to present and summarise M&S project findings.
- At all times scientific data and interpretation must be communicated clearly and credibly. External presentation and publication in peer reviewed technical manuscripts is required.
The successful candidate will have extensive relevant pharma, CRO/CDMO experience. Hands on experience in the use of M&S in a pre-clinical/translational setting (late stage discovery/early clinical R&D), is essential and you should consider yourself to be a specialist in one or more of WinNonlin Phoenix, GastroPlus or SimCYP.
Other skills and experience required:
- A broad cross-functional knowledge of early drug development
- An effective member of multi-disciplinary teams and be able to deliver multiple projects to stringent timelines.
- Degree qualified, ideally with a PhD, in a discipline with a significant component of Modelling and Simulation.
- Occasional travel may be required in worldwide to meet clients, participate in global conferences, or present at workshops, seminars and conferences.
In return, you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.