Biotechnology Jobs

• Waltham, United States
• US$203,775 – US$339,625 pa
• Director

Provides scientific and strategic leadership for real-world evidence supporting an mRNA vaccine portfolio, with a primary focus on influenza. Shapes evidence generation across late-stage development, launch and post-marketing, leading US post-marketing vaccine effectiveness studies and complex external collaborations with academic and healthcare data partners.

Medicare · EHR · Administrative Claims +1

• London
• US$203,775 – US$339,625 pa
• Director

Provides scientific and strategic leadership for real-world evidence supporting an mRNA vaccine portfolio, with a primary focus on influenza. Shapes evidence generation across late-stage development, launch and post-marketing phases, leading US post-marketing vaccine effectiveness studies and complex external collaborations with academic and healthcare data partners.

Medicare · EHR · Administrative Claims +1

• London
• Hybrid
• £63,917 – £118,703 pa
• Director

Acts as a QA liaison between clinical trial teams and third parties, providing expert support through due diligence, qualification, governance and ongoing monitoring. Focuses on technology-enabled vendors such as digital health tools, medical devices and AI, covering risk assessment, audit support, inspection readiness and escalation of quality issues.

DHT · SaMD · SaaS +1

• Home Worker
• Remote
• £67,900 – £126,100 pa
• Senior

Lead the authoring of high-complexity regulatory documents and act as Program Writer for complex programmes, overseeing writing strategy, coordination, planning and resourcing. Provide expert guidance to clinical trial and submission teams, shape data analysis planning, and champion best practices, new technologies and AI tools to improve writing quality and efficiency.

Artificial Intelligence

• Livingston
• Mid-level

Leads strategic sourcing of animal models, especially rodents and genetically engineered strains, for an early-phase discovery business. Manages supplier relationships, RFIs/RFPs, contract negotiations and performance reviews, while partnering with scientific, veterinary and quality teams on capacity planning, welfare and regulatory compliance.

• Reading
• Hybrid
• Mid-level

Supports clinical trials by designing, setting up and maintaining Interactive Response Technology (IRT) solutions, translating supply requirements into system specifications. Contributes to risk assessments, user acceptance testing and validation documentation, and advises study teams on IRT processes. Works with cross-functional global stakeholders on study startup, amendments and continuous improvement.

IRT · RTSM · IVRS +1

• London
• Hybrid
• Senior

Leads regional or global regulatory strategy for development programs and marketed products, serving as a regulatory lead and primary contact with health authorities. Manages preparation, submission and approval of regulatory applications, advises teams on approval pathways and expedited routes, and monitors regulatory intelligence to inform strategy.

• London
• On-site
• Director
• Permanent

Leads CMC regulatory strategy for global submissions including IND, CTA, BLA and MAA, and oversees agency correspondence and compliance for mRNA products. Reviews submissions for readiness, drives health authority interactions, and advises manufacturing and quality teams on change controls and regulatory guidance across vaccines, oncology and rare disease programmes.

IND · CTA · BLA +1

• 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

• US - East Coast
• Hybrid
• Director

Oversees an outsourced global data management vendor across CAR T and autoimmune clinical trials, from protocol development through regulatory submission. Manages eCRF standards, data review and QC plans, database release and lock, and inspection readiness, acting as the main liaison between study teams, vendors and functional partners. Based hybrid in the UK or remote on the US East Coast.

eTMF · eCRF · SAS +2

• United Kingdom
• Remote
• Senior

Acts as independent Principal Investigator overseeing qualitative in-trial research studies, from design through delivery, for pharmaceutical clients. Applies methods like interviews and surveys to capture patient experience data, manages project budgets and timelines, and contributes to proposals and client development. Requires CAQDAS expertise and strong scientific writing.

Atlas.ti · NVivo · MAXQDA +1

• United Kingdom
• Remote
• Director · manages people

Senior medical leadership role within a clinical research organisation, acting as a cardiovascular subject matter expert supporting proposals, bid defences and client engagement. Responsibilities span RFP input, protocol and regulatory strategy, internal therapeutic training, and mentoring clinical scientists, with peer-level interaction with pharma medical leadership.

PPD

• Macclesfield
• On-site
• Senior
• Permanent · Shift work

Provides QA leadership and GMP/aseptic expertise for aseptic manufacturing and packaging on a permanent night shift, working a 4-on, 4-off pattern. Advises on cleanroom compliance, deviations, CAPA, change control and product release, and coaches manufacturing staff on contamination control and data integrity within the Process Execution Team.

EU GMP Annex 1 · ICH Q9 · ICH Q10 +2

• Uxbridge
• Hybrid
• Senior · manages people

Technical lead on assigned clinical studies, shaping SDTM strategies from protocol review through to global regulatory submission. Involves root cause analysis, cross-functional collaboration, data integration from CRF and non-CRF sources, and engagement with SDTM automation, metadata-driven processes and agentic AI workflows. Also provides quality oversight to team members and manages CRO and vendor programming activities.

Pinnacle 21

• Macclesfield
• On-site
• Permanent

Collects environmental monitoring and cleaning validation samples in sterile manufacturing facilities, then performs microbiological and QC testing such as bioburden, endotoxin, concentration and conductivity analysis. Manages the full sample lifecycle in LIMS, reviews monitoring plans, investigates out-of-specification results and GMP-assesses data. Works a continuous two-week rotating pattern of 11-hour day shifts.

LIMS