Biotechnology Jobs

• Waltham, United States
• Hybrid · 2 days in office
• US$242,250 – US$403,750 pa
• Director · manages people

Owns the clinical strategy, scientific narrative and benefit-risk framework for a genitourinary oncology asset, acting as the senior clinical voice on the Medicine Development Team core quad. Leads governance and investment discussions, Health Authority interactions and evidence-generation strategy, while directing Senior Scientists who handle study-level delivery. Hybrid role with at least two days per week on-site.

AI-enabled Insights · Data Platforms

• Stevenage
• Hybrid · 2 days in office
• US$242,250 – US$403,750 pa
• Director · manages people

Owns the clinical strategy, scientific narrative and benefit-risk framework for a genitourinary oncology asset, acting as the senior clinical voice on the Medicine Development Team core quad. Leads governance and health authority interactions while directing Senior Scientists who handle study-level delivery, and mentors clinical development talent.

AI

• 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

• Reading
• Remote
• Senior
• Permanent

Supports Pharmacometrics by programming, validating and delivering NONMEM-ready PK/PD datasets from SDTM/ADaM sources using advanced R, covering pre-lock and post-lock clinical data. Includes QC of datasets from external partners and of custom R packages, plus liaison with Data Management, Biostatistics and Bioanalytical teams and regulatory submission deliverables.

R · NONMEM · SDTM +1

• London
• Hybrid
• £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. Partner with clinical trial and submission teams, shape data analysis planning, and champion AI tools to improve regulatory writing quality and efficiency.

Artificial Intelligence

• 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

• London
• Hybrid · 3 days in office
• Senior · manages people

Lead computational chemistry strategy across drug discovery programs, applying AI-first approaches to hit finding, molecular design and lead optimisation. Work with ML scientists to embed generative models into cheminformatics workflows, with some roles managing 2-3 computational chemists.

REINVENT · AlphaFold · Large Language Models

• London
• Hybrid · 3 days in office
• Senior

Lead translational pharmacology for an AI-first drug discovery team, shaping neurodegeneration strategy and target validation. Bridge dry-lab predictive models with experimental biology, designing screening cascades and profiling AI-designed molecules. Manage CRO partnerships and serve as scientific lead for portfolio programs.

SPR · TR-FRET · Mass Spectrometry

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

Leads scientific safety assessments for assigned medicinal products, partnering with Medical Safety Officers to prepare analyses and evaluations for regulatory compliance. Supports Safety Management Teams, conducts proactive safety data reviews, and serves as product point of contact, with hybrid working requiring three days on site.

Microsoft Word · Microsoft Excel · Microsoft PowerPoint

• 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

• London
• Remote
• Mid-level
• Permanent

Field-based medical affairs role acting as a scientific partner to healthcare professionals and thought leaders across the East Midlands, Yorkshire and East of England. Involves non-promotional scientific exchange, medical education, advisory boards, and supporting investigator-sponsored and real-world evidence studies within a neuroscience portfolio, working closely with UK, Ireland and global teams.

ABPI Code

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

Lead national medical strategy for the Respiratory & Immunology business unit, spanning inhaled therapies and biologics. Define pre-launch and launch medical plans, drive NHS transforming-care initiatives, and oversee MSL and healthcare delivery teams. Provide scientific leadership across regulatory, market access and real-world evidence work.

NHS · NICE · SMC +3

• High Wycombe
• Hybrid · 3 days in office
• Entry level
• Internship

A 12-week summer internship in EMEA Global Regulatory Affairs within the Oncology therapeutic area, working on a hybrid model with three days on site. Interns join a global matrixed team supporting clinical strategies and Phase I-III oncology studies, contributing to regulatory strategy, clinical trial applications and product registration activities, with a mentor, cross-functional team meetings and a research poster presented at a company-wide symposium.

Microsoft Outlook · Microsoft Excel · Microsoft PowerPoint +5

• 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.