Biotechnology Jobs

• Stevenage
• US$188,100 – US$313,500 pa
• Director

Lead end-to-end application of Model-Informed Drug Development across the drug development lifecycle, from first-in-human studies through filing and lifecycle management, providing clinical pharmacology strategy and evidence generation. Draft and review regulatory content for FDA, EMA, CDE, PMDA and ICH, and build cross-functional partnerships across digital medicine, translational imaging, AI/ML and biostatistics. The role sits in the newly established Clinical Pharmacology and Quantitative Medicine organisation, reporting into the Respiratory, Immunology & Inflammation Research Unit.

MIDD · QSP · AI/ML

• Durham, United States
• US$188,100 – US$313,500 pa
• Director

Leads end-to-end application of Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Partners with digital medicine, translational imaging, modelling and biostatistics teams, and drafts regulatory content for FDA, EMA, CDE, PMDA and ICH submissions. Based in the newly formed Clinical Pharmacology and Quantitative Medicine organisation, with a strong publication and scientific leadership remit.

MIDD · QSP · AI/ML

• London
• Lead

Serves as subject matter expert in COA endpoint strategy, instrument development and regulatory strategy, advising pharma and biotech sponsors and representing the company as an external scientific thought leader. Leads qualitative research supporting content validity, oversees internal project teams, mentors consultants and supports business development through proposals and client presentations.

• Livingston
• Senior

Conducts site qualification, initiation, monitoring and close-out visits for a dedicated sponsor program, ensuring GCP compliance, patient safety and data integrity. Builds investigator relationships, drives recruitment and retention, and mentors junior team members, with up to 40-60% regional travel.

Investigator Site Files (ISF) · Trial Master Files (TMF)

• United Kingdom
• Remote
• Lead

Lead medical writer dedicated to a single client, authoring and reviewing clinical study reports, protocols, IBs, INDs and MAAs while advising on document strategy and regulatory requirements. Provides senior review, mentoring and training to junior writers and program managers, and leads process improvement initiatives. Therapeutic experience in neurology, immunology, oncology or vaccines is valued.

• United Kingdom

Field-based role maintaining and repairing Roche diagnostic systems across molecular, tissue and serum work areas, using on-site and remote diagnostics to resolve complex electro-mechanical faults. Involves preventive maintenance, reporting, customer technical training and regulatory documentation, working within a UK customer-centric field support team.

Roche Diagnostics Systems · Remote Diagnostic Tools · Digital Portfolio

• United Kingdom
• Remote

Field-based role maintaining Roche diagnostic systems across molecular, tissue and serum work areas, using on-site support and remote diagnostics to resolve complex electro-mechanical faults. Duties include preventive maintenance, reporting, customer technical training and regulatory documentation, working within a UK customer-centric field support team.

Roche Diagnostics Systems

• London
• Mid-level
• Permanent

Deliver and maintain UK competitive licences, lead regulatory strategy for new initiatives, and ensure compliance across defined products and projects. Provide local regulatory expertise for clinical trial approvals, lifecycle submissions and MHRA interactions, contributing to cross-functional teams and study feasibility work.

Veeva · AI

• London
• On-site
• Director

Shape global CMC regulatory strategy for an innovative mRNA medicines portfolio, driving international submissions and health authority interactions. Prepare and review CMC sections of regulatory filings, advise Manufacturing and Quality teams, and oversee multiple development programs. An individual contributor role with global reach, working alongside teams using digital and Generative AI tools.

Generative AI

• Leeds
• On-site
• Entry level
• Internship

A 12-month university placement within a global clinical data management team, supporting the full clinical trial lifecycle from project documentation and system set-up to data entry, validation, reconciliation and database lock. Interns work alongside experienced Clinical Data Managers on live trials, gaining hands-on exposure to clinical research technology and processes.

• United Kingdom
• Remote
• Senior · manages people

Lead and oversee a large portfolio of patient-centered outcomes and in-trial research studies as an independent PI, delegating project management to junior scientific staff. Responsible for scientific quality, client relationships, timelines and contracted budgets, with work presented in peer-reviewed journals and at professional meetings. Requires strong analytical skills and familiarity with SAS or similar data analysis software.

Microsoft Word · Microsoft PowerPoint · Microsoft Excel +1

• Harrow
• Remote
• Mid-level

Manage worldwide post-approval regulatory activities for biological and plasma products, focusing on CMC variations, renewals, market expansions and annual reports. Assess change controls, review quality control and production study reports, and coordinate submission content with manufacturing, supply chain and QA teams. Client-dedicated role working in Regulatory Information Management systems such as Veeva Vault.

Veeva Vault · Word · PowerPoint +1

• 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

• Maidenhead
• Senior

Leads safety surveillance and signal detection across a product's lifecycle, reviewing clinical and post-marketing data and contributing to aggregate safety reports and risk management plans. Partners with Global Safety Leads and cross-functional teams, mentors junior scientists, and supports regulatory responses.

Microsoft Excel

• London
• Hybrid
• £83,930 – £155,870 pa
• Director

Supports the development, launch and continuous improvement of AI-powered products, working alongside Line Function Product Owners and cross-functional teams to translate product vision and strategy. Manages the product lifecycle from MVP through scaling, tracking budget and value metrics, and collaborating with DDIT and external parties on delivery and handover to maintenance.

Pandas · R