Biotechnology Jobs

499 jobs for “Clinical Supply Irt Specialist”

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GSK · 10000+ people · Public

Medical Director Clinical Development- Respiratory

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  • Stevenage
  • Hybrid · 2 days in office
  • US$222,750 – US$371,250 pa
  • Director

Provides clinical and scientific leadership across early and late-stage respiratory programmes, shaping clinical development plans, study designs and regulatory documents. Leads a cross-functional Clinical Matrix Team, oversees medical monitoring and safety governance, and partners with biology, regulatory, commercial and statistics groups to advance differentiated medicines.

3 months ago
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GSK · 10000+ people · Public

Medical Director Clinical Development- Respiratory

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  • USA - Pennsylvania - Upper Providence
  • Hybrid · 2 days in office
  • US$222,750 – US$371,250 pa
  • Director

Provides clinical and scientific leadership across early and late-stage respiratory programs, designing clinical development plans, protocols and regulatory documents while overseeing medical monitoring and participant safety. Leads a cross-functional Clinical Matrix Team, shaping translational strategy, target validation and evidence generation in partnership with biology, regulatory and commercial groups.

3 months ago
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GSK · 10000+ people · Public

Director, Cardiovascular and metabolic diseases, Clinical Pharmacology Modeling and Simulation

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  • 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

Last week
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GSK · 10000+ people · Public

Director, Oncology Translational Medicine, Clinical Biomarkers

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  • 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

2 days ago
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GSK · 10000+ people · Public

Director, Oncology Translational Medicine, Clinical Biomarkers

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  • 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

2 weeks ago
GSK logo

GSK · 10000+ people · Public

Director, Oncology Translational Medicine, Clinical Biomarkers

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  • London
  • 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. 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

2 weeks ago
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GSK · 10000+ people · Public

Senior Director, Cardiovascular and Metabolic Diseases, Clinical Pharmacology Modeling and Simulation

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  • 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

Last week
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GSK · 10000+ people · Public

Senior Director, Cardiovascular and Metabolic Diseases, Clinical Pharmacology Modeling and Simulation

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  • 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

Last week
GSK logo

GSK · 10000+ people · Public

Director, Cardiovascular and metabolic diseases, Clinical Pharmacology Modeling and Simulation

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  • 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

Last week
GSK logo

GSK · 10000+ people · Public

Director, Cardiovascular and metabolic diseases, Clinical Pharmacology Modeling and Simulation

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  • 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

Last week
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GSK · 10000+ people · Public

Principal Programmer Analyst

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  • 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.

R

Last month
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GSK · 10000+ people · Public

Principal Programmer Analyst

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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.

R

Last month
GSK logo

GSK · 10000+ people · Public

Principal Programmer Analyst

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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.

R

Last month
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GSK · 10000+ people · Public

Senior, AI Product Manager (Process Development Science)

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  • Stevenage
  • Hybrid · 2–3 days in office
  • Senior

Sits within GSK's Chemical Manufacturing & Control function, identifying and sizing AI opportunities across process development science for oligonucleotides, ADCs and monoclonal antibodies. Partners with forward deployed engineering pods to turn ambiguous business problems into scoped, buildable products, and shapes self-driving lab and in silico modelling initiatives.

Self-Driving Labs · Agentic Workflows · Physical AI

Last week
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GSK · 10000+ people · Public

Senior, AI Product Manager (Process Development Science)

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  • London
  • Hybrid · 2–3 days in office
  • Senior

Sits within GSK's CMC function, identifying and sizing AI opportunities across process development science for oligonucleotides, ADCs and monoclonal antibodies. Partners with forward deployed engineering pods to turn ambiguous business problems into scoped, buildable products, and shapes self-driving lab and in silico modelling initiatives.

AI Platforms · ML Platforms

Last week

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