Senior Clinical Project Manager - UK

Senior Clinical Trial Manager / Clinical Operations Lead

Rare Disease Biotech | UK or Ireland | Permanent |

Are you an experienced Clinical Operations professional who thrives in lean biotech environments and enjoys taking ownership of global studies from start-up through execution?

We are partnering with an innovative biotechnology company focused on developing therapies for ultra-rare dermatological diseases. Following a significant recent funding round and with a pivotal Phase III programme preparing to enter its next stage, the business is seeking a highly experienced Clinical Trial Manager / Clinical Operations Lead to oversee outsourced clinical activities across a global development programme.

This is an opportunity to join at a critical stage of growth, working directly with senior leadership and playing a key role in shaping the future of the clinical function.

The Opportunity

You will act as the operational lead for a global Phase IIb/III rare disease study, managing external CROs, vendors and study partners whilst ensuring studies are delivered to timeline, budget and quality expectations.

Working within a highly agile biotech environment, you will have significant autonomy and visibility. The successful candidate will be comfortable operating strategically while remaining hands-on when required.

There is also potential for longer-term progression into broader clinical leadership responsibilities as the organisation continues to grow.

Key Responsibilities

• Lead operational oversight of global clinical trials across rare disease programmes.
• Manage and oversee CRO performance, ensuring delivery against agreed milestones, quality standards and budgets.
• Act as the primary contact for outsourced clinical operations activities.
• Collaborate closely with senior internal stakeholders, external vendors and investigative sites globally.
• Monitor study timelines, risks and mitigation plans.
• Review key study documents, metrics and vendor deliverables.
• Ensure studies are conducted in accordance with GCP, regulatory requirements and company SOPs.
• Support inspection and audit readiness activities.
• Drive communication and coordination across study teams located in North America, Europe and APAC regions.
• Contribute to the ongoing development and scaling of the clinical operations function.

Candidate Profile

Essential

• Significant Clinical Operations experience within biotechnology and/or pharmaceutical development.
• Proven CRO oversight and vendor management experience.
• Recent experience working on rare disease clinical programmes.
• Experience operating in small biotech, virtual biotech or highly outsourced clinical development environments.
• Strong understanding of ICH-GCP and global clinical trial regulations.
• Experience delivering Phase II and/or Phase III clinical studies.
• Ability to work independently with minimal infrastructure and high levels of accountability.
• Flexibility to support meetings and collaborations across US time zones when required.

Highly Desirable

• Experience in ultra-rare diseases.
• Dermatology clinical trial experience.
• Experience managing global studies with small patient populations.
• Interest in developing into a broader clinical leadership position over time.

What's on Offer?

• Competitive salary
• Annual bonus (circa 10%).
• Pension scheme.
• Health insurance support/reimbursement.
• Remote-based position in the UK or Republic of Ireland.
• Opportunity to make a significant impact within a growing, well-funded biotech.
• Exposure to pivotal-stage development programmes with potential registration milestones.

Location

Remote within the United Kingdom or Republic of Ireland.

Candidates must be willing to support occasional meetings outside standard business hours to accommodate global study teams and CRO partners based in the United States.