Biotechnology Jobs

• Waltham, United States
• Hybrid
• US$189,750 – US$316,250 pa
• Director

Leads precision diagnostics strategy for oncology programs, defining diagnostic requirements for trials and overseeing biomarker selection, assay validation, and sample collection. Partners cross-functionally with research, clinical, regulatory, and commercial teams, and engages external diagnostic companies and labs to accelerate assay development. Hybrid role based in Waltham, MA.

FDA · EU IVDR · PMDA/MHLW Japan +2

• Stevenage
• Hybrid
• Lead

Owns operational delivery of diagnostics across early and late-stage oncology trials, covering biosample collection, processing and storage, and implementation of clinical trial assays at reference and central labs and CROs. Works in a matrix with biomarker, clinical operations, data management, regulatory and procurement colleagues, managing vendors, contracts and data transfer agreements while keeping studies audit-ready.

• 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

• 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.

• United Kingdom
• Remote
• Director · manages people

Senior physician role leading medical science and strategy for oncology across a clinical research business, shaping RFP responses, bid defences and protocol design while engaging client medical leadership. Also provides therapeutic training, mentoring and regulatory document input, working in a matrixed global team with international travel.

• London
• Hybrid
• Mid-level

Leads global cross-functional teams to plan, coordinate and deliver regulatory submissions for new marketing authorisations, new indications and other major filings. Manages integrated submission timelines, scenario planning, risk mitigation and forecasts, working with Regulatory Affairs, Clinical, Quality and Manufacturing under the CTD/eCTD framework.

RIMS

• London
• Hybrid
• Senior

Plans and executes medical and scientific engagement activities such as advisory boards, congress symposia, external expert engagements and medical education programmes across oncology, cardiovascular, renal, neuroscience and immunology. Works within the International Medical Affairs Center of Excellence, translating engagement strategy into operational plans, managing vendors, logistics and budgets, and reinforcing compliant, audit-ready ways of working.

CRM Software

• London
• Lead · manages people

Provides technical leadership in setting up and operating a CDMO site, leading process development and analytical method development projects for cell therapy manufacture. Plans technology transfers, ensures regulatory compliance, drives continuous improvement, and mentors colleagues while engaging directly with clients.

MHRA · EMA · FDA