519 jobs for “Research Associate In Biomaterials And I”
Leads precision diagnostics strategy for oncology programmes, defining biomarker selection, assay validation and sample collection across multiple assets. Oversees project plans, budgets and regulatory submissions while managing external diagnostic partners and clinical labs. Hybrid role based in Stevenage, relocating to Cambridge by early 2029.
FDA · EU IVDR · PMDA/MHLW Japan +2
Leads precision diagnostics strategy for oncology programs, defining diagnostic requirements for trials and overseeing biomarker selection, assay validation, and sample collection. Partners cross-functionally with research, clinical, regulatory, and commercial teams, and engages external diagnostic companies and labs to accelerate assay development. Hybrid role based in Waltham, MA.
FDA · EU IVDR · PMDA/MHLW Japan +2
GSK · 10000+ people · Public
Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Coordinates CPMS activities across assets, approves study designs and regulatory documents, and works with digital medicine, translational imaging and modelling specialists. Based in Stevenage with a planned relocation to Cambridge, UK by early 2029.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Coordinates CPMS activities across assets, approves study designs and regulatory documents, and partners with digital medicine, translational imaging, biostatistics and AI/ML teams. Reports into the Respiratory, Immunology & Inflammation Research Unit within the new Clinical Pharmacology and Quantitative Medicine organisation.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Drafts regulatory content for FDA, EMA, CDE, PMDA and ICH submissions, and partners with digital medicine, translational imaging, modelling and data science teams to embed quantitative approaches into asset-level decisions.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Sits in the Clinical Pharmacology and Quantitative Medicine organisation, partnering with digital medicine, translational imaging, modelling and data science teams, and drafting regulatory content for FDA, EMA and ICH submissions.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Lead end-to-end application of Model-Informed Drug Development across the drug development lifecycle, from first-in-human studies through filing and lifecycle management, providing clinical pharmacology strategy and evidence generation. Draft and review regulatory content for FDA, EMA, CDE, PMDA and ICH, and build cross-functional partnerships across digital medicine, translational imaging, AI/ML and biostatistics. The role sits in the newly established Clinical Pharmacology and Quantitative Medicine organisation, reporting into the Respiratory, Immunology & Inflammation Research Unit.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Leads end-to-end application of Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Partners with digital medicine, translational imaging, modelling and biostatistics teams, and drafts regulatory content for FDA, EMA, CDE, PMDA and ICH submissions. Based in the newly formed Clinical Pharmacology and Quantitative Medicine organisation, with a strong publication and scientific leadership remit.
MIDD · QSP · AI/ML
GSK · 10000+ people · Public
Leads model-informed drug development for oncology programmes, defining and executing model-based strategies from late pre-candidate selection through life cycle management. Conducts population PK, exposure-response and simulation-based trial design work across small molecules, biologics and antibody drug conjugates, applying AI/ML and quantitative systems pharmacology methods. Presents and defends modelling outcomes to governance boards and regulators, and contributes to protocols, analysis plans and submissions.
NONMEM · R
GSK · 10000+ people · Public
Joins the Genomic Technologies group within Translational Sciences, working in an existing Statistical Genetics team. Develops and tests production methods for analysing large-scale human genetic data, integrating genetic association data across omic and phenotypic layers to identify causal genes, drug targets and biomarkers. Collaborates with Data and Predictive Sciences, Biostatistics, AI/ML and disease area teams to influence portfolio decisions.
PySpark · BigQuery · Docker +3
GSK · 10000+ people · Public
Leads the design and execution of clinical biomarker and translational medicine strategies for late-stage oncology assets, defining patient segmentation and decision criteria within Clinical Matrix Teams. Validates predictive, pharmacodynamic and resistance biomarkers using platforms such as NGS, FISH, PCR, IHC/IF, flow cytometry, liquid biopsy/ctDNA and multi-omic analyses, and oversees sample testing plans and biomarker data packages for clinical and regulatory decisions.
NGS · FISH · PCR +6
GSK · 10000+ people · Public
Leads global medical writing for the Respiratory, Immunology and Inflammation portfolio, directing strategy, resource planning and vendor oversight to deliver regulatory-compliant clinical documentation. Drives submission acceleration, digital innovation and cross-functional partnerships across R&D, with accountability for talent development and operational excellence.
Content Management Systems
GSK · 10000+ people · Public
Leads the design and execution of clinical biomarker and translational medicine strategies for late-stage oncology assets, defining patient segmentation and decision criteria within Clinical Matrix Teams. Validates predictive, pharmacodynamic and resistance biomarkers using platforms such as NGS, ctDNA, flow cytometry and multi-omic analyses to inform dose selection and go/no-go decisions.
IHC/IF · Liquid Biopsy · ctDNA +3
GSK · 10000+ people · Public
Leads the design and execution of clinical biomarker and translational medicine strategies for late-stage oncology assets, defining patient segmentation and decision criteria within Clinical Matrix Teams. Oversees biomarker assay development, sample testing plans and data packages across platforms such as NGS, IHC, flow cytometry and ctDNA, working with internal and external partners.
IHC/IF · Liquid Biopsy · ctDNA +3
GSK · 10000+ people · Public
Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Coordinates CPMS activities across assets, approves study designs and regulatory documents, and partners with digital medicine, translational imaging and modelling specialists. Reports into the Respiratory, Immunology & Inflammation Research Unit within the new CPQM organisation.
MIDD · QSP · AI/ML
