Biotechnology Jobs

500 jobs for “Clinical Supply Irt Specialist”

Results

GSK logo

GSK · 10000+ people · Public

Clinical Development Medical Director- Hepatology

Save job
  • London
  • Hybrid · 2 days in office
  • US$202,500 – US$371,250 pa
  • Director · manages people

Leads clinical development strategy for hepatology assets within GSK's Respiratory, Immunology & Inflammation Research Unit, from target identification through proof-of-concept studies. Accountable for clinical matrix team leadership, protocol design, medical monitoring and regulatory interactions across all development phases. Hybrid role with at least two on-site days weekly.

Last month
GSK logo

GSK · 10000+ people · Public

Clinical Development Medical Director- Hepatology

Save job
  • Boston, United States
  • Hybrid · 2 days in office
  • US$222,750 – US$371,250 pa
  • Director · manages people

Leads clinical development strategy for hepatology assets within the Respiratory, Immunology & Inflammation Research Unit, overseeing study design, medical monitoring, and regulatory interactions. Accountable for the Clinical Matrix Team, target validation, translational plans, and Go/No Go decision criteria across early-phase programs. Hybrid role requiring on-site presence at least two days per week.

Last month

IQVIA

Principal Biostatistician (Immunology) - FSP

Save job
  • Reading
  • Lead

Provides principal-level statistical leadership across Phase II and III clinical trials, independently leading SAP authoring and review while supporting integration activities across studies and programmes. Acts as a proactive statistical partner to clinical, programming and regulatory teams, ensuring compliant, high-quality outputs are delivered on time. Requires strong R programming and immunology therapeutic area exposure is desirable.

R

Last week

IQVIA

Freelance Site Activation Specialist (Study Start-Up / Regulatory Submissions)

Save job
  • London
  • Remote
  • Freelance

Supports UK clinical trial start-up by collecting and reviewing site and regulatory documentation, preparing submission packages, and coordinating Informed Consent Form adaptations. Liaises with investigative sites and internal study teams to resolve outstanding documents and track progress against milestones, ensuring ICH-GCP and local regulatory compliance.

Last week
Novartis logo

Novartis

Regulatory Writer

Save job
  • Home Worker
  • Remote
  • £49,140 – £91,260 pa

Author and manage high-quality regulatory documents for medicines, working with cross-functional clinical and submission teams. Advise on regulatory writing standards, lead writing plans and timelines, and apply AI tools to improve quality and efficiency. Requires strong biostatistics understanding and global regulatory knowledge.

Artificial Intelligence

Yesterday
Novartis logo

Novartis

CTA Submission Manager

Save job
  • Home Worker
  • Remote
  • £47,540 – £88,289 pa
  • Mid-level

Manages regulatory activities for clinical trial applications across an assigned portfolio, leading high-quality submissions and coordinating responses to Health Authority queries. Works closely with study teams, country leads and cross-functional partners to identify regulatory risks early and secure timely approvals, while contributing to simplification and automation initiatives across Regulatory Affairs.

Last week

Autolus · 101–500 people · Series C

Senior Engineer, CSV Validation

Save job
  • Stevenage
  • Hybrid
  • Senior

Hands-on senior role owning the computerised-system lifecycle for GxP systems, from impact and supplier assessments through validation, release, operation and retirement. Authors and executes CSV documentation, performs data integrity and 21 CFR Part 11 assessments, manages change controls and CAPAs, and supports regulatory inspections as a CSV subject matter expert.

SaaS · Cloud

3 months ago

Thermo Fisher Scientific

CRA I/II/ Sr CRA - FSP - UK

Save job
  • United Kingdom
  • Remote
  • Senior

Clinical Research Associate role within PPD's Functional Service Provider division, dedicated to a client and embedded in multi-national project teams. You perform and coordinate all aspects of clinical monitoring, conducting monitoring activities independently across challenging projects. Requires ICH-GCP, EU and FDA knowledge, with award-winning training provided.

Last month

Thermo Fisher Scientific

ED/VP Medical Science & Strategy - Metabolic

Save job
  • United Kingdom
  • Remote
  • Director · manages people

Senior physician role providing metabolic therapeutic and drug-development expertise to a clinical research organisation, supporting major proposals and bid defences, client peer-to-peer engagement, and protocol design. Also trains and mentors internal clinical teams, authors regulatory documents, and liaises with investigators and KOLs. Requires an MD with metabolic subspecialty certification and fluency in English and Mandarin, with travel to China.

3 months ago

Moderna · 1001–5000 people · Late stage

Sr. Manager, Site Budgets and Contracts

Save job
  • Oxford
  • On-site
  • Senior

Leads the creation, review and oversight of investigator site budgets and grants across Phase I–IV clinical trials, using Grants Manager/GrantPlan and FMV benchmarking. Manages CRO site budget and CTA negotiations, scenario planning and site activation timelines, with exposure to Generative AI tools for analytics.

Grants Manager · GrantPlan · MS Office +1

2 months ago

Moderna · 1001–5000 people · Late stage

Senior Research Associate, Bioanalytical & Molecular Assays - Ligand Binding Assays

Save job
  • Oxford
  • Hybrid · 3–4 days in office
  • Senior
  • Permanent

Develops, validates and runs ligand-binding and cell-based bioanalytical assays generating pharmacodynamic and immunogenicity data for clinical mRNA programmes. Works in a GcLP-regulated lab using Thermo Watson LIMS and electronic notebooks, handling clinical samples, critical reagents, SOPs and validation reports while partnering with Clinical Operations and Sample Management.

Thermo Watson LIMS · Watson LIMS · LabVantage eLBN +1

Visa sponsorship 4 months ago
Bluetree logo

Bluetree · 11–50 people

Senior Regulatory Affairs & Quality Manager

  • Cambridge
  • Hybrid · 2 days in office
  • £65,000 – £80,000 pa
  • Senior
  • Permanent

Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.

FDA · MHRA · UKCA +2

3 weeks ago
City St George's, University of London logo

City St George's, University of London · 501–1000 people · Public

Lecturer in Human Genetics and Genomics

Save job
  • London
  • £51,753 – £53,301 pa
  • Contract · Part time

Supports teaching, assessment and curriculum development for an online Genomic Medicine programme, including distance-learning provision and postgraduate education. Supervises student research projects and works with clinical partners to align content with contemporary genomic healthcare practice.

2 days ago
University of Surrey logo

University of Surrey · 1001–5000 people

Lecturer/Senior Lecturer in AI and One Health Biomedical Data Sciences

Save job
  • Guildford
  • £48,337 – £70,878 pa
  • Senior
  • Permanent

Develop an independent, externally funded research programme as a Principal Investigator, applying AI and data science to human, animal and environmental health data within a One Health framework. Collaborate across medicine, veterinary science, computer science and engineering, secure UKRI/NIHR/Wellcome funding, publish high-impact work, and teach AI and data science at undergraduate and postgraduate level.

Last month
Isomorphic Labs logo

Isomorphic Labs · 201–500 people · Series A

Research Leader / Senior Scientist (Medicinal Drug Design), Cambridge, MA

Save job
  • Cambridge, United States
  • Hybrid · 3 days in office
  • Senior · manages people

Experienced medicinal chemists lead portfolio drug discovery projects from initiation to clinical candidate selection, working as Project Lead or Medicinal Chemistry Lead. They partner closely with ML scientists to refine the AI drug design platform, manage CRO resources, and may line-manage teams of 2-4 chemists.

AlphaFold

3 months ago

Get new Clinical Supply Irt Specialist roles by email. One email a morning when new roles match. Stop any time.

Are you sure?