Biotechnology Jobs

• Baar Onyx
• Hybrid
• US$189,750 – US$316,250 pa
• Director

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

• USA - Pennsylvania - Upper Providence
• Hybrid
• US$189,750 – US$316,250 pa
• Director

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

• London
• US$188,100 – US$313,500 pa
• Director

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

• Stevenage
• US$188,100 – US$313,500 pa
• Director

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

• Durham, United States
• US$188,100 – US$313,500 pa
• Director

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

• Stevenage
• Hybrid
• £119,250 – £198,750 pa
• Director

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

• Baar Onyx
• US$188,100 – US$313,500 pa
• Director

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 biostatistics teams, and drafting regulatory content for FDA, EMA and ICH submissions.

MIDD · QSP · AI/ML

• USA - Pennsylvania - Upper Providence
• US$188,100 – US$313,500 pa
• Director

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. Designs MIDD and ClinPharm evidence strategies, drafts regulatory content for FDA, EMA, CDE, PMDA and ICH, and partners with digital medicine, translational imaging, modelling and data science teams. Sits in the newly formed Clinical Pharmacology and Quantitative Medicine organisation.

MIDD · QSP · AI/ML

• Waltham, United States
• Hybrid
• £188,100 – £313,500 pa
• Director

Leads model-informed drug development for oncology programs, defining and executing model-based strategies from late discovery through lifecycle management. Conducts population PK, exposure-response, simulation-based trial design and dose selection, applying AI/ML, quantitative systems pharmacology and model-based meta-analysis. Presents to governance boards and regulators and works across matrix teams on small molecules, biologics and antibody drug conjugates.

NONMEM · R

• London
• Hybrid
• £119,250 – £198,750 pa
• Director

Leads model-informed drug development for oncology programmes, defining and executing model-based strategies from late candidate selection through life cycle management. Conducts population PK, exposure-response and simulation-based trial design work, applying AI/ML and quantitative systems pharmacology methods, and defends results to governance boards and regulators. Sits within Oncology Translational Medicine's Clinical Pharmacology Modelling and Simulation group, working across small molecules, biologics and antibody drug conjugates.

NONMEM · R

• Belgium-Wavre
• Hybrid
• €119,250 – €198,750 pa
• Director

Leads model-informed drug development for oncology programmes, defining and executing model-based strategies from late candidate selection through life cycle management. Conducts population PK, exposure-response and simulation-based trial design work, applying AI/ML, quantitative systems pharmacology and model-based meta-analysis to small molecules, biologics and antibody drug conjugates. Presents and defends modelling outcomes to governance boards and regulators, and contributes to protocols, analysis plans and submissions.

NONMEM · R

• USA - Pennsylvania - Upper Providence
• Hybrid
• US$188,100 – US$313,500 pa
• Director

Leads model-informed drug development for oncology programmes, defining and executing model-based strategies from late 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

• Durham Blackwell Street
• Hybrid
• US$188,100 – US$313,500 pa
• Director

Leads model-informed drug development for oncology programmes, defining and executing model-based strategies from late candidate selection through life cycle management. Conducts population PK, exposure-response and simulation-based trial design work, applying AI/ML and quantitative systems pharmacology methods, and defends results to governance boards and regulators. Sits within a matrixed Clinical Pharmacology Modelling and Simulation group working across small molecules, biologics and antibody drug conjugates.

NONMEM · R

• Waltham, United States
• Hybrid
• US$222,750 – US$371,250 pa
• Director

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 cross-functional partners in digital medicine, translational imaging and systems modelling. Based in the newly established Clinical Pharmacology and Quantitative Medicine organisation.

MIDD · QSP · AI/ML

• London
• Hybrid
• US$222,750 – US$371,250 pa
• Director

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, imaging, modelling and data science partners. Reports into the Respiratory, Immunology & Inflammation Research Unit.

AI/ML · Digital Medicine · Translational Imaging +3