Biotechnology Jobs

• USA - Pennsylvania - Upper Providence
• On-site
• US$284,250 – US$473,750 pa
• Director

Leads clinical development of GU oncology assets, designing and executing Phase 1-3 interventional trials and serving as a core member of the Clinical Matrix Team. Provides real-time medical monitoring, safety data review with pharmacovigilance, and authors clinical study reports and regulatory responses. Builds key external expert relationships and contributes to business development diligence.

• Waltham, United States
• Hybrid · 2–3 days in office
• US$222,750 – US$371,250 pa
• Director

Serves as the physician on oncology clinical programme teams for lung and head/neck cancers, leading medical monitoring, safety oversight and clinical data interpretation across Phase I–III studies. Partners with a Senior Scientist and cross-functional matrix teams on protocol development, regulatory interactions and investigator engagement, with on-site presence 2–3 days per week.

AI

• London
• Freelance

Monitors Phase I-IV clinical trials across UK sites, conducting evaluation, initiation, interim and close-out visits in line with GCP and sponsor requirements. Works closely with the Clinical Trial Manager and Lead CRA, handling source verification, eCRF/EDC data review, query resolution and site training. Requires oncology monitoring experience and involves travel plus mentoring of less experienced CRAs.

EDC · eCRF

• Reading
• Senior

Monitors oncology clinical trial sites through selection, initiation, monitoring and close-out visits, ensuring GCP and ICH compliance. Tracks recruitment, regulatory submissions, CRF completion and data queries, and maintains Trial Master File documentation. Works within a biotech-focused team supporting emerging biopharma sponsors.

Microsoft Word · Microsoft Excel · Microsoft PowerPoint

• 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.

• Home Worker
• Remote
• £49,140 – £91,260 pa
• Lead · manages people

Leads statistical programming strategy for clinical trials and programs, acting as Trial, Lead or Program Programmer and coordinating internal and external teams. Develops and validates CDISC-compliant datasets and outputs for regulatory submissions, using R, SAS or Python, Git-based version control and reproducible workflows. Also shapes standards, templates and governance across studies.

R Shiny · Tidyverse · Git +2

• London
• Hybrid
• Senior

Designs end-to-end data solutions spanning data integration, data warehousing, master data management, governance and analytics for a biopharmaceutical company. Translates business requirements into data models, data flows and integration patterns, and leads architecture and design reviews across enterprise applications and cloud data platforms.

SaaS · APIs · Cloud Data Platforms

• 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

• New York, United States
• Hybrid · 2–3 days in office
• US$151,800 – US$220,660 pa
• Senior

Integrate phenomics, transcriptomics, genomics and proteomics data to nominate novel targets and validate immunology and inflammation disease biology, piloting new methods for target discovery and early patient population hypotheses. Partner cross-functionally with biologists, chemists, data scientists and engineers to build data packages that drive program milestones and investment decisions.

Python · R · CRISPR

• New York, United States
• Hybrid · 2–3 days in office
• US$151,800 – US$220,660 pa
• Senior

Integrates phenomics, transcriptomics, genomics and proteomics data to nominate and validate oncology targets and define precision oncology patient strategies. Partners cross-functionally with biologists, chemists, engineers and translational experts to build target data packages and pilot novel discovery methods, including agentic target packages and mechanism-of-action work.

CRISPR

• Uxbridge
• Hybrid
• Director

As a member of cross-functional development teams, you will contribute to trial design, protocol development, analysis planning, and regulatory submissions, with the option to support a specific asset indication. The role involves authoring statistical analysis plans and clinical study reports, defending protocols at governance reviews, and providing statistical leadership on health authority requests. It requires 50% onsite presence in Uxbridge and proficiency in SAS, R, or Python.

SAS · R · Python

• Cambridge
• Hybrid · 3 days in office
• Director · manages people

Owns International regulatory strategy for complex cell therapy programs, embedding regional requirements into evidence generation, submissions and labeling. Leads BLA/MAA planning, Health Authority engagements and labeling negotiations, integrating clinical, CMC, safety and commercial input. Also leads a matrix regulatory team, coaching colleagues and shaping policy and process improvements.

BLA · MAA · IND +2

• 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.

• 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

• Welwyn
• Hybrid
• Director

Provides safety science and pharmacovigilance support across the Roche portfolio, covering signal detection, benefit-risk assessment, ICSR case management and aggregate reporting such as DSUR and PBRER. The role also involves preparing CCDS, labelling, RMP and REMS documents and shaping drug safety input into clinical development strategy. Level is set by experience, working with a global team from the Welwyn office.

DSUR · PBRER · CCDS +3