Biotechnology Jobs

497 jobs for “Clinical Supply Irt Specialist”

Results

GSK logo

GSK · 10000+ people · Public

VP, Medicine Development Leader- Cancer Vaccines, Oncology Research Unit

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  • London
  • Hybrid · 2 days in office
  • US$340,500 – US$567,500 pa
  • Senior · manages people

Leads global development of a cancer vaccine asset from late-stage transition through approval and launch, acting as single point of accountability and chairing a cross-functional matrix Medicine Development Team spanning clinical, translational, regulatory, manufacturing and commercial. Drives strategy, go/no-go decisions and lifecycle plans for novel vaccine platforms such as mRNA and neoantigen-based therapies.

mRNA · Checkpoint Inhibitors

3 weeks ago
GSK logo

GSK · 10000+ people · Public

VP, Medicine Development Leader- Cancer Vaccines, Oncology Research Unit

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  • Waltham, United States
  • 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 represents the asset to senior governance boards.

mRNA · Personalized Vaccine Manufacturing · Checkpoint Inhibitors

3 weeks ago

IQVIA

Clinical Research Associate II

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  • Livingston
  • Mid-level

Conducts site qualification, initiation, monitoring and close-out visits for a dedicated clinical trial program, 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.

Investigator Site Files · Trial Master Files

2 days ago

IQVIA

Senior Clinical Research Associate

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  • Reading
  • Senior

Monitors clinical trial sites across the UK, handling selection, initiation, monitoring and close-out visits in line with GCP and ICH guidelines. Manages multiple protocols, drives subject recruitment, tracks regulatory submissions and CRF data, and maintains Trial Master File documentation. Based in Reading with regular travel to investigative sites.

3 weeks ago

Fortrea

CRA II - SCRA I - Midlands - FSP

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  • Maidenhead
  • Mid-level

Monitors and oversees clinical trial sites across the Midlands, handling site initiation, monitoring visits and closeouts while ensuring GCP compliance and patient safety. Also supports feasibility assessments, investigator recruitment, vendor coordination, SAE reporting and mentoring of junior team members within a global FSP team.

3 weeks ago

Thermo Fisher Scientific

Senior CTM, Hematology/Oncology

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  • United Kingdom
  • Remote
  • Senior · manages people

Accountable for delivering clean clinical data on time and within contract for low-to-moderate complexity haematology/oncology trials, managing operational and quality aspects in line with ICH GCP. Develops monitoring plans, CRF documents and Trial Master File content, tracks timelines and metrics, and may handle start-up, ethics submissions and project financials. Works within a team of CTMs, with travel to sites and a focus on radiopharmaceuticals, cell & gene therapy and CAR-T studies.

Outlook · Excel · Word

Last month
CSL logo

CSL · 10001+ people · Public

Associate Director, Biostatistics

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  • Opfikon, Switzerland
  • 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 and internal statistical programmers, and supports departmental improvement initiatives.

SAS · R

Last week

Parexel

Executive Director, Biostatistics Scientific Advisory

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  • London
  • Remote
  • Director

Provides statistical consulting and strategic advice on optimal study designs and analyses across drug, device, and diagnostic clinical development, including preparation for regulatory authority interactions. Serves as a leader in innovative study designs for client accounts and supports new business through proposals, bids, and client presentations, representing clients at key regulatory meetings.

FDA · EMEA · MHRA +2

2 weeks ago

Hudson Shribman

Preclinical In-Vitro Toxicology Scientist

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  • United Kingdom
  • £55,000 – £70,000 pa

This role involves leading in-vitro toxicology studies within a regulated preclinical environment, focusing on assay development and execution for product safety assessment. The scientist will apply advanced cell-based methods including Neutral Red, Ames, and micronucleus assays, interpret complex biological data, and support regulatory submissions. Collaboration with internal teams and external partners is key, alongside method validation and scientific reporting in a quality-assured laboratory setting.

Last month

Parexel

Medical Director/Study Physician - CD Inflammation - Sponsor Dedicated

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  • London
  • Remote
  • Director

Medically responsible at trial level across preparation, conduct and reporting phases, providing medical expertise and oversight from Trial Design Outline to Clinical Trial Report. Dedicated to a single sponsor in the EMEA region, the role involves authoring high-quality clinical trial protocols, co-authoring Clinical Quality Monitoring plans, integrating medically relevant data into risk-based quality management, and performing ongoing reviews of medical data.

4 months ago

Thermo Fisher Scientific

Sr/CRA I/II - UK (numerous locations)

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  • United Kingdom
  • Remote
  • Senior

Monitors investigator sites using a risk-based approach, conducting remote and on-site visits to assess protocol and regulatory compliance, performing SDR, SDV and CRF review, and documenting findings in reports. Acts as a site processes specialist ensuring trials follow ICH-GCP, applicable regulations and SOPs, while developing collaborative relationships with investigational sites and supporting audit readiness.

CTMS · Microsoft Office

3 weeks ago

Fortrea

Senior CRA

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  • Maidenhead
  • Senior

Lead and manage clinical trial sites across a diverse portfolio spanning oncology, neuroscience, cell & gene and CAR-T therapies. The role emphasises patient safety, data integrity and building trusted relationships with investigators, with autonomy and support for complex, innovative study designs.

8 months ago
CSL logo

CSL · 10001+ people · Public

Senior Pharmacovigilance Scientist (Vaccines/ Products of National Significance)

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  • Opfikon, Switzerland
  • Senior

Leads safety review and end-to-end signal detection across a product's lifecycle, using quantitative and qualitative methods alongside Global Safety Leads. Contributes to aggregate safety reports, risk management plans and regulatory responses, and mentors junior PVS staff. Works cross-functionally with Development, Medical Affairs and Regulatory teams on vaccine and national-significance products.

Microsoft Excel

2 weeks ago
Novartis logo

Novartis

Lead Central Monitor

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  • London
  • Hybrid
  • €63,600 – €118,000 pa
  • Lead · manages people

Lead and develop a team of Central Monitors while shaping risk-based monitoring strategies across a global clinical development portfolio. Oversee trial-data surveillance, signal detection and Key Risk Indicators, translating complex risk signals into actionable insights for Clinical Trial Teams. Works in a global matrix with clinical, data and risk-surveillance teams, driving continuous improvement through analytics and technology.

Artificial Intelligence

Last month
Novartis logo

Novartis

Lead Central Monitor

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  • Dublin, Ireland
  • Hybrid
  • €63,600 – €118,000 pa
  • Lead · manages people

Lead and develop a team of Central Monitors while shaping risk-based monitoring strategies across a global clinical development portfolio. Oversee trial-data surveillance, signal detection and insight generation, translating complex risk signals into actionable insights and designing study-specific Key Risk Indicators and Quality Tolerance Limits.

Artificial Intelligence

Last month

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