Bioanalytical Scientific Manager - United Kingdom
- Experience in the pharma or CRO industry supporting regulatory bio analysis of small or large molecules
- Extensive knowledge of a range of bio analytical techniques including LC-MS/MS, immunoassay, flow cytometry and quantitative PCR to support the analysis of pharmacokinetic and pharmacodynamics endpoints (e.g. NCEs, NBEs, ADA and biomarkers)
- Extensive knowledge of the latest regulatory standards required for GXP studies, including international guidance’s published by regulatory agencies such as FDA, EMA
- Experience working with a wide range of internal stakeholders, including non-clinical safety, DMPK, clinical pharmacologists, translational medicine, clinical operations and quality assurance colleagues.
- Previous experience managing CROs to ensure appropriate level scientific and technical content is provided in support of programs
- Demonstrated ability to influence teams to ensure bioanalytical data generated is of the highest quality
Role and Responsibilities:
- Perform the role of bioanalytical representative by acting as single point of contact for all bioanalytical actives of programs assigned for internal and external stakeholders. This will entail but not be limited to:
- Setting and refining the bioanalytical strategy for PK, ADA and biomarker analysis within preclinical and clinical studies
- Drive the scientific discussion and rational for all bioanalytical endpoints
- Evaluate a broad spectrum of available technologies to ensure quantitative assay are fit for purpose
- Actively contribute to teams such as NCD protect teams, clinical study teams and PSTs as appropriate
- Perform the role of study monitor for bio-analytical assay validation and sample analysis studies.
- Responsible for troubleshoot technical issues with the support of Bio-analytical scientist
- Well organized, capable of communicating clear instruction to partners and stakeholders
- Monitor and review technical and operational capabilities of CROs through tools such as KPIs, technical audits (typically once every two years), communication plans and ensure the bioanalytical outsourcing matrix is kept up-to-date via regular meetings with partners to ensure operational timelines are clearly communicated and consistently met.
- Contribute to the preparation and review of study protocols, reports, communication plans etc.
- Keep abreast of latest technologies and publications in the field of regulatory bioanalysis
- Ensure all contracts are in place prior to the start of the study and ensure all invoices are approved for payment
- Proven track record of engagement in the external bio analytical community, via publications and presentations at international conferences on a regular basis.
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