Biotechnology Jobs

• Zug, Switzerland
• Hybrid · 2 days in office
• US$340,500 – US$567,500 pa
• Director · manages people

Leads global development of a cancer vaccine asset from late-stage transition through approval and launch, acting as single point of accountability across major markets. Builds and directs a matrix Medicine Development Team spanning clinical development, immunology/biomarkers, manufacturing, regulatory, safety, medical affairs and commercial, and serves as asset spokesperson to senior governance boards.

mRNA · Checkpoint Inhibitors

• London
• Hybrid · 2–3 days in office
• Director · manages people

Leads a global oncology labelling team, managing the labelling process from early development through lifecycle management and ensuring regulatory compliance. Serves on the Global Labelling Committee, advises senior R&D, Safety, Regulatory and Commercial leaders, and engages with regulatory authorities on labelling standards and policy.

• Stevenage
• 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, translational imaging and modelling specialists. Based in Stevenage with a planned relocation to Cambridge, UK by early 2029.

MIDD · QSP · AI/ML

• Durham, 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 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

• Waltham, United States
• 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. 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

• 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

• Baar Onyx
• 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 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

• USA - Pennsylvania - Upper Providence
• 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 partners with digital medicine, translational imaging, biostatistics and AI/ML teams. Sits in the newly formed Clinical Pharmacology and Quantitative Medicine organisation, reporting into the Respiratory, Immunology & Inflammation Research Unit.

AI/ML · Digital Medicine · Translational Imaging +2

• 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

• London
• Hybrid
• Lead

Lead programming activities for one or more clinical studies, developing, maintaining and validating complex analysis packages to CDISC and Good Programming Practice standards. Act as technical mentor to junior programmers and lead programming support for regulatory interactions with the EMA and FDA. Works in an agile, squad-based team bridging scientific requirements with technical solutions, with R proficiency preferred.

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• Stevenage
• Hybrid
• Lead

Leads statistical programming for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Acts as a technical mentor to junior programmers and leads programming support for regulatory interactions with bodies such as the EMA and FDA, working in an agile, squad-based team alongside clinical, statistical and operational stakeholders.

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• USA - Pennsylvania - Upper Providence
• Hybrid
• Lead

Lead programming activities for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Mentor junior programmers, support regulatory interactions with EMA and FDA, and bridge scientific requirements with technical solutions in an agile, squad-based global team.

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