Biotechnology Jobs

• London
• Hybrid
• Director · manages people

Leads global operational delivery of early development oncology programs, managing Clinical Project Managers, Monitoring Leads and CTAs. Owns the clinical development plan, CRO and site selection strategy, budgets and timelines, and serves on Asset Teams. Requires deep first-in-human and Phase I oncology trial expertise.

Microsoft Office

• London
• Hybrid
• Senior

Leads global clinical data transparency and disclosure across registries and regulatory platforms such as CTIS, EMA Policy 0070 and Health Canada PRCI, acting as subject matter expert for assigned therapeutic areas. Manages vendor partnerships, FOI access requests, redaction and lay summary work, plus SOP governance, compliance reporting and audit readiness within Global Regulatory Affairs Excellence.

CTIS · ClinicalTrials.gov · EU Clinical Trial Register +3

• Opfikon, Switzerland
• Lead · manages people

Provides medical and scientific expertise on clinical safety across a product's lifecycle, with emphasis on signal detection, risk management and regulatory submissions. Chairs the Safety Management Team, oversees aggregate reports such as DSURs, PSURs and RMPs, and acts as the safety representative in cross-functional development and post-marketing teams.

DSUR · PSUR · RMP +3

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

Accountable for end-to-end clinical development strategy for a multi-tumor oncology asset, spanning first-in-human through registrational trials, regulatory approval and initial launch. Acts as senior clinical representative at governance forums and leads cross-functional collaboration across research, precision medicine, medical affairs and commercial in a global matrix.

AI/ML

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

Accountable for end-to-end clinical development of a multi-tumor oncology asset, from first-in-human through registrational trials, regulatory approval and launch. Leads cross-functional strategy with research, precision medicine, medical affairs and commercial partners, and represents the program at senior governance forums. Requires deep antibody-drug conjugate and global regulatory experience.

• 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 · 3 days in office
• Mid-level

Hands-on health economics role leading the delivery of cost-utility and budget impact models in Excel and VBA for national HTA submissions to NICE, SMC and AWMSG. Partners with UK Market Access, Medical and Brand teams plus the global HEOR function, and also builds early cost-effectiveness models for future brands and indications.

Microsoft Excel · Microsoft VBA

• Uxbridge
• Director · manages people

Leads clinical strategy and execution for one or more GI oncology indications of a given asset, owning the Target Product Profile and disease area strategy. Manages a team of physicians and scientists designing, running, analysing and interpreting all clinical studies, and acts as internal and external clinical authority for regulatory interactions and business development. Requires deep therapeutic expertise and 8+ years of drug development experience, with international and domestic travel.

• 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

• London
• Remote
• Mid-level

Manages a portfolio of clinical research studies end to end, leading cross-functional teams and client relationships for Patient Cloud products such as eCOA/ePRO, eConsent and virtual trials. Involves risk assessment, study documentation and milestone tracking, with flexibility needed to work American time zones.

MS Office Suite · Google Workspace

• Macclesfield
• On-site
• Senior
• Permanent

Perform routine and non-routine analytical testing of pharmaceutical oral drug products and new modalities using HPLC, Karl Fischer, dissolution and mass spectrometry. Review data for GLS and GMP compliance, investigate out-of-specification results, and develop, optimise and validate analytical methods while training colleagues and driving continuous improvement at a client's Macclesfield facility.

HPLC · Karl Fischer · Mass Spectrometry +1

• Macclesfield
• On-site
• Mid-level
• Permanent

Perform routine and non-routine analytical testing of pharmaceutical oral drug products and new modalities using HPLC, Karl Fischer, dissolution and mass spectrometry. Review data for GLS and GMP compliance, investigate out-of-specification results, and develop and validate analytical methods while training colleagues and supporting client projects at a Macclesfield pharma facility.

HPLC · Karl Fischer · Mass Spectrometry +1

• 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

• Bedford
• On-site
• £30,000 – £35,000 pa
• Entry level
• Temporary

Supports the set-up, conduct and monitoring of internal clinical studies, covering supply sourcing and shipment, volunteer recruitment, payment administration, source data verification and testing. Maintains inspection-ready documentation and reports study status to the wider clinical team, working to GCP and relevant IVDR/ISO standards.

Microsoft 365 · Outlook · Word +2

• Edinburgh
• Lead

Designs, delivers and interprets complex molecular and cellular biology studies for drug discovery and translational research, combining hands-on lab work with technical direction across client programmes. Provides scientific leadership on multiple projects, evaluates new technologies and supports colleagues, working with mammalian cell cultures and advanced cellular systems.