RQ Biotechnology Ltd.
Clinical Operations Manager / Senior Clinical Operations Manager – Phase I/II Antibody Programme
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RQ Bio: Clinical Operations Manager/Senior Manager
RQ Bio is a UK virology biotech developing long-acting monoclonal antibodies for influenza. We're hiring a Clinical Operations Manager or Senior Manager to take real operational ownership of our Phase I study, then Phase II, and to help plan Phase III as the programme moves forward. You'll be part of a small clinical team, close to the people making decisions, and you'll shape how RQ Bio runs its trials. The role grows as the programme does.
The opportunity
This is a hands-on role in a lean sponsor team. You won't be one function among many: you'll be the person who makes our clinical studies happen. You'll work closely with our CROs and vendors, hold them to account, and build the processes, documents and habits that get a young clinical programme ready for inspection. If you've run studies in a large organisation and want more breadth and influence, or you already work in biotech and want to grow with a programme through to late-stage development, this role offers both.
What you will own
- Day-to-day delivery of our Phase I study, then Phase II, from start-up through to close-out
- Oversight of CROs and vendors: performance, deliverables, timelines and budgets
- Study plans, risk logs and budget tracking. You'll raise problems early and bring options with them
- eTMF/TMF quality and completeness, keeping the study ready for inspection at all times
- Risk-based quality management in line with GCP and ICH E6(R3)
- Study documentation and SOPs: writing, reviewing and improving them as the clinical function grows
- Input into Phase III planning as the programme matures
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What RQ Bio is looking for
- Sponsor-side clinical operations or study management experience, including independently managing Phase I and/or Phase II trials
- Typically 5–8+ years of hands-on study or clinical project management. What matters is time spent owning studies, not total years in clinical research
- A track record of managing CROs and vendors against timelines, budgets, risks and deliverables
- Experience on global or multi-country studies
- Strong working knowledge of GCP, ICH E6(R3), eTMF/TMF, RBQM and inspection readiness
- Experience in biotech or another lean sponsor setting where your role went well beyond a narrow remit. We'll consider large-pharma backgrounds where you can show real hands-on study ownership and breadth
- Good judgement and clear, proactive communication with internal stakeholders and external partners
- Willingness to roll your sleeves up. In a small biotech there's no department to hand things off to: one day you're shaping study strategy, the next you're chasing a vendor deliverable or tidying the TMF yourself
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Desirable experience
- Infectious disease, influenza, vaccines, biologics or monoclonal antibodies. Helpful, but strong study ownership matters more than therapeutic area
- Contributing to late-phase or Phase III planning
- Setting up or improving clinical SOPs and quality processes in an early-stage company
Working arrangements
- Hybrid and UK-based, aligned to London, with roughly one day a week in the office
- Occasional meetings in Cambridge
- £60,000–£80,000, depending on experience and whether you're appointed at Manager or Senior Manager level
If you've run Phase I or II studies end to end and want more ownership than a large organisation can give you, apply here for a confidential conversation.
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