Biotechnology Jobs

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

Provides clinical and scientific leadership across respiratory and immunology clinical development programmes, shaping clinical development plans, study designs and regulatory documents. Leads a cross-functional Clinical Matrix Team, oversees medical monitoring and safety governance, and acts as the clinical point of contact for regulators, investigators and key external experts. Hybrid working with at least two days per week on-site.

• 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.

• Reading
• Mid-level

Monitors clinical trial sites across the UK, performing selection, initiation, monitoring and close-out visits in line with GCP and sponsor requirements. Tracks recruitment, regulatory submissions, CRF completion and data queries, and maintains TMF/ISF documentation. Dedicated to a single sponsor within IQVIA's cFSP model.

Microsoft Word · Microsoft Excel · Microsoft PowerPoint

• Leeds
• Entry level
• Internship

A 12-month student placement in the clinical research department, supporting international trials of medical technology products. Duties include administering and coordinating the logistical aspects of clinical studies, tracking essential documents, and collecting and recording study data, with meetings alongside cross-functional partners.

Microsoft Excel · Microsoft Word · Microsoft PowerPoint

• 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.

• Maidenhead
• Mid-level · manages people

Leads the preparation and finalisation of clinical documents within the Regulatory Medical Writing team, supporting the Immunology therapeutic area. Takes a lead role on assigned projects for content, scientific strategy, timing and tracking, and manages direct reports including hiring, goal-setting and development. Involves guiding cross-functional teams, peer review and maintaining knowledge of ICH and regulatory guidelines.

• Maidenhead
• Lead · manages people

Client-facing biostatistics role leading design and analysis of non-interventional and low-interventional studies using real-world data such as claims, EHR and registries. Applies causal inference methods, target trial emulation and synthetic control arms, authors SAPs and manages SAS programming teams, while supporting proposals, budgeting and bid defences.

SAS · CDISC

• 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

• Cambridge
• Senior

Design and develop novel mechatronic systems for medical devices, including liquid handling machines and surgical robotic systems, within a multidisciplinary R&D team. Take concepts through iterations to manufacture, designing intricate mechanisms while owning wider system development. Open on sector background, but complex mechatronics experience is key.

SolidWorks · Pro/ENGINEER

• Oxford
• On-site
• £39,424 – £46,476 pa
• Mid-level
• Contract

Carry out research in spatial immunometabolism focused on the germinal centre reaction within the Clarke group at the Kennedy Institute of Rheumatology. The role involves developing new scientific techniques and experimental protocols, testing hypotheses, analysing data, contributing ideas for new projects, and providing guidance to postdocs, technicians and PhD students.

• United Kingdom - Walton Oaks
• Hybrid

Lead and implement regional regulatory strategies for assigned products, acting as the regional representative within Pfizer's Global Regulatory Strategic Team. Accountable for timely submissions, approvals and optimal interactions with Health Authorities, partnering cross-functionally to align regulatory plans with commercial goals.

ChatGPT · Microsoft Copilot

• 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

• 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

• 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.

• Uxbridge
• Hybrid
• Senior

An individual contributor role conducting non-interventional real-world data research for medical and HEOR teams across international markets. You will identify data sources, oversee statistical programming in R, and interpret and present findings to stakeholders. The position requires deep expertise in observational data analysis and offers hybrid working from Uxbridge.

R · GitHub · Claude +2