Non-Clinical Project Manager

Project Manager | Clinical-Stage Gene Therapy | [London, hybrid 3 days a week]

This is a unique opportunity to help build an early-stage, AI-driven biotech from the inside.

My client is a stealth biotech advancing a clinical-stage AAV gene therapy programme. As Project Manager, you'll own the integrated execution plan and operating cadence across clinical development, regulatory, CMC and manufacturing, quality, finance and company build, working closely with leadership, functional experts, partners and vendors.

You won't need to be the scientific, clinical, regulatory or manufacturing expert in every discussion. Your job is to make the whole programme work: credible plans, visible dependencies, clear owners and deadlines, recorded decisions, and risks escalated early enough to be solved.

WHAT YOU'LL DO

• Own the integrated programme plan, turning company strategy into one practical plan of milestones, dependencies, owners, decision points and critical paths

• Drive the execution cadence through cross-functional planning, programme reviews and follow-up

• Own the risk, issue, dependency, action and decision logs, escalating slippage early with clear options

• Produce concise dashboards, forecasts and executive and board-ready updates

• Coordinate clinical programme delivery across CRO, site, imaging, data, biostatistics and PV workstreams, supporting Phase 3 readiness

• Manage timelines and inputs for regulatory interactions and submissions

• Integrate the CMC plan (manufacturing, scale-up, tech transfer, release and supply) and align it with clinical demand

• Track scopes, POs, budgets, forecasts and change requests, investigating variances

• Prepare steering and governance meetings, and support RFPs, contracting and performance management for CROs and vendors

• Build the programme-management system: templates, tools, reporting, meeting cadences and working norms

• Support financing, partnering and diligence with programme evidence, plans and data-room materials

WHAT YOU'LL BRING

• Previous demonstrated project or programme management in biotech, including responsibility for a clinical-stage asset or major cross-functional development workstream

• Working knowledge of drug development across clinical operations, regulatory, CMC, quality, safety, data and finance

• Experience managing external partners such as CROs, CDMOs, laboratories and alliance partners

• Strong command of integrated plans, budgets, forecasts, dashboards, governance packs and risk management

• Excellent communication, with the confidence to engage senior executives, clinicians, scientists and board members

• High ownership: you create structure in ambiguity, challenge weak assumptions constructively and escalate before a problem becomes a crisis

NICE TO HAVE

• Gene therapy, ATMP, AAV or other complex biologic experience

• Phase 2/3 or global interventional trial experience

• Manufacturing scale-up, tech transfer, comparability or clinical supply planning

• Joint venture, strategic alliance or company-build experience

• Financing, partnering, diligence or data-room preparation

• A degree in life sciences, medicine or engineering, and/or a PM qualification

Interested? Message me directly or send your CV to sarah@fusiongroupglobal.com