Biotechnology Jobs

497 jobs for “Clinical Supply Irt Specialist”

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GSK logo

GSK · 10000+ people · Public

VP, Medicine Development Leader - Specialty Product Development

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  • London
  • Hybrid · 2 days in office
  • US$242,250 – US$403,750 pa
  • Director · manages people

Leads the global development of a medicine from clinical Proof of Concept to approval in first major markets, acting as single point of accountability. Builds and directs a matrixed Medicine Development Team spanning clinical, medical, commercial and manufacturing, driving strategy, governance and go/no-go decisions. Hybrid role with at least two days per week on-site.

3 months ago
GSK logo

GSK · 10000+ people · Public

VP, Medicine Development Leader, Oncology - GI

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  • USA - Pennsylvania - Upper Providence
  • Hybrid · 2 days in office
  • US$266,250 – US$443,750 pa
  • Director · manages people

Strategically leads global development of an oncology medicine from clinical Proof of Concept to approval in first major markets, acting as single point of accountability. Builds and leads a matrixed Medicine Development Team spanning clinical, medical, commercial and manufacturing, driving evidence packages, governance decisions and lifecycle plans.

6 days ago

IQVIA

Clinical Research Associate II

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  • Manchester
  • Mid-level

Conducts site qualification, initiation, monitoring and close-out visits for clinical trials, ensuring GCP compliance, patient safety and data integrity. Builds relationships with investigators, resolves data queries, mentors junior staff and travels up to 40-60% within the region. Embedded in a sponsor-dedicated functional service partnership model.

Investigator Site Files · Trial Master Files

2 days ago

IQVIA

Clinical Research Associate II

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  • Bath
  • Mid-level

Conducts site qualification, initiation, monitoring and close-out visits for a CRO embedded within pharmaceutical sponsor teams, ensuring GCP compliance, patient safety and data integrity. Manages site relationships, recruitment strategies, TMF/ISF documentation and risk escalation, with mentoring of junior staff and up to 40-60% regional travel.

Investigator Site Files · Trial Master Files

2 days ago

Fortrea

Unblinded CRA I (Scotland, North of England)

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  • Maidenhead
  • Mid-level

Unblinded monitoring of pharmacies at clinical trial sites across Scotland and the North of England, with possible additional UK and Ireland sites. Involves Investigational Product oversight, ICH-GCP compliance, eTMF documentation and acting as primary contact for pharmacy monitoring, within a sponsor-dedicated team.

eTMF

Last week

Fortrea

Medical Writer I Yorkshire

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  • Leeds
  • Hybrid · 3 days in office
  • Entry level
  • Permanent

Develops protocols and clinical study reports for early-phase trials (I-IIa), focusing on safety and pharmacokinetics. Coordinates cross-functional teams and client stakeholders to drive documents from draft to final deliverable, with on-the-job training in medical writing.

5 days ago

Thermo Fisher Scientific

Senior CTM, Internal Medicine (Dermatology, Nephrology, Cardiovascular, Women's Health, GI, Immunology, Rare Disease)

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  • United Kingdom
  • Remote
  • Senior

Accountable for delivering clean clinical data on complex internal medicine trials within contract timelines, managing operational and quality aspects in compliance with ICH GCP. Leads clinical teams, develops monitoring tools and Trial Master File documentation, and may take on Lead CTM or Clinical Study Manager duties across therapeutic areas.

Outlook · Excel · Word

5 days ago

Thermo Fisher Scientific

Scientist – Extended Characterization Europe - Client-dedicated - FSP

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  • Stevenage
  • On-site
  • Mid-level

Performs complex sample preparation and quantitative analysis of small molecules and biotherapeutics using instrumentation such as GC-MS, ICP-OES, HPLC and LC-MS, supporting both GMP and non-GMP stability studies. Works largely independently to set up, maintain and troubleshoot analytical instrumentation, interpret data for technical validity and compliance, and report results to client teams. Based full-time onsite at a pharmaceutical client site as part of a functional service provider partnership.

GC-MS · ICP-OES · HPLC +2

Last month
CSL logo

CSL · 10001+ people · Public

Associate Director, Biostatistics

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  • Maidenhead
  • Hybrid · 3 days in office
  • US$212,000 – US$251,000 pa
  • Director

Leads the full statistical contribution to a clinical development programme, defining statistical strategy for trial design, analysis and regulatory submissions, and representing Biostatistics in interactions with the FDA, EMA and PMDA. Also manages outsourcing to CROs/FSPs and contributes to governance and development-plan decisions across therapeutic areas.

SAS · R

Last week
CSL logo

CSL · 10001+ people · Public

Associate Director, Biostatistics

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  • Breda, Netherlands
  • Hybrid · 3 days in office
  • US$212,000 – US$251,000 pa
  • Director

Leads the full scope of statistical contribution to a clinical development programme, defining statistical strategy and methodologies for trial design, analysis and regulatory submissions. Represents Biostatistics in interactions with authorities such as FDA, EMA and PMDA, and manages outsourcing or internal statistical programmers. Two positions support multiple therapeutic areas.

SAS · R

Last week
Novartis logo

Novartis

Director, Translational Medicine Expert (Neurodegeneration)

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  • London
  • Hybrid
  • Director

Leads end-to-end translational strategy for neurodegenerative and neuromuscular programs, bridging preclinical research to Phase 1–2 clinical development. Accountable for biomarker strategy, clinical endpoint selection and early-phase trial design, and serves as the Translational Medicine representative within global cross-functional project and clinical trial teams.

3 weeks ago

Moderna · 1001–5000 people · Late stage

Principal Scientist, Immunogenicity and Ligand Binding Assays

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  • Oxford
  • Hybrid · 3–4 days in office
  • Lead
  • Permanent

Provides scientific and hands-on leadership for immunogenicity and ligand binding assay bioanalysis supporting mRNA-LNP therapeutic programs, spanning assay development, validation, clinical sample testing and regulatory submissions. Ensures GcLP compliance and partners with cross-functional teams, with opportunities to work alongside data and AI-enabled analytical approaches.

ECL · Gyrolabs · Reporter Gene Assays +3

Visa sponsorship 5 months ago

Moderna · 1001–5000 people · Late stage

Scientist, Genetic Assays

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  • Oxford
  • On-site
  • Senior

Sole-contributor scientist role developing and executing biochemical and molecular biology assays for PK/PD analysis, spanning genomic DNA/RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA and immunoblotting. Works within Moderna's Clinical Bioanalytical team at Harwell, Oxfordshire, ensuring GcLP-compliant assay qualification and validation, troubleshooting with external CRO partners, and building internal and external mRNA-based bioanalytical capability.

MSD · LIMS · eLNB +1

Last month

Parexel

Senior Regulatory Affairs Manager - CMC bio/vax (various European locations - home or office based)

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  • Harrow
  • Remote
  • Senior

Senior regulatory affairs consultant role focused on CMC writing and variations strategy for vaccines and biological products. You will draft CMC sections and scientific rationales for submissions, coordinate activities across multiple projects, liaise with global affiliates and manufacturing sites, and manage client relationships on a dedicated project without people-management duties. Work is home or office based across various European locations.

FDA · EMA · MHRA

Last week

University of Exeter

PhD Studentship: From Variants to Placental Function: Using Cell-free DNA to Dissect the Functional Genomics of Adverse Pregnancy Outcomes

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  • Exeter
  • Entry level
  • Contract

Computational PhD project using cell-free DNA sequencing to infer placental gene activity and dissect how genetic variants linked to adverse pregnancy outcomes affect placental function. The student develops tools to map nucleosomal footprints, integrates them with single-cell RNA-seq markers and GWAS summary statistics, and may generate new plasma data.

scRNA-seq · cfDNA Sequencing · GWAS

Last week

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