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DMPK Project Leader
- Provide leadership, design and successful delivery of DMPK/PKPD strategies for siRNA drug discovery and development projects.
- Develop strategies and technologies (in house or via outsourcing) to advance the understanding DMPK and therapeutic index of ds Gal-Nac conjugated siRNA
- Develop and execute effective non-clinical PK/PD strategies for novel extrahepatic targeted siRNAs.
This is an exciting opportunity to join an expanding group supporting a growing pipeline of leading edge siRNA projects. We are looking for an individual with solid knowledge and experience in DMPK and with additional expertise/ a keen interest in bioanalysis. Development of ds siRNA is highly specific and innovative. It demands resourcefulness as well as sound scientific and regulatory understanding. A background involving relevant experience in the development of oligonucleotides, RNA or similar modalities is desirable.
- Develop and execute effective non-clinical ADME and PK/PD strategies from early discovery through to development.
- Delivery of project goals through interpretation of results and integration of data with other disciplines. This includes the optimisation of ADME and PK properties, DDI assessments, formulation recommendations, PKPD.
- Support the DMPK portion and bioanalysis of preclinical in vivo studies for the Silence portfolio: contribute to study plans and interpretation of DMPK and bioanalytical data
- Ensure robust estimations of human PK and dose prediction to guide project direction and clinical potential.
- Engage external experts to challenge, review and adjust currently applicable regulatory thinking and ADME framework.
- Author relevant high level regulatory documents.
The candidate will be able to demonstrate the following competencies and behaviours:
- PhD or equivalent experience in DMPK, bioanalytical sciences or comparable
- Expert level understanding of pharmacokinetics and PKPD
- Experience in PK, PKPD and/or PBPK modelling
- A track record of transitioning projects from discovery to the clinic, able to demonstrate successful prediction of pharmacokinetics using a variety of methods.
- Extensive experience and knowledge of the full drug development processes in the Pharma Industry environment with proven experience in successfully developing and executing effective nonclinical PK/PD strategies from early discovery through to development.
- A calm leader and team player with a proactive and positive problem-solving mindset, confident to contribute strategically and implement ideas. You should be comfortable working in a fast-paced, dynamic environment and on multiple projects with changing priorities and deadlines.
- Excellent communication skills, able to collaborate with internal and external colleagues at all levels.
- Resourceful and innovative