Quality and Clinical Consultancy, and Technical Operations Team Build

RRxCo was engaged by a clinical-stage biotechnology company focused on developing innovative biologic therapies for serious immune-mediated diseases with high unmet medical need. The organisation was entering a critical growth phase, transitioning from early development into more advanced, multi-regional clinical activity.

Background

The company is advancing a portfolio of novel therapeutic candidates designed to modulate key biological pathways involved in complex inflammatory and autoimmune conditions. With a lean internal structure and an ambition to progress multiple programmes in parallel, the business required a scalable operating model that could support clinical development, manufacturing readiness, and regulatory expectations across global markets. Key strategic objectives included advancing clinical programmes efficiently, establishing fit-for-purpose quality and supply infrastructure, and ensuring long-term flexibility as development timelines evolved. Operating discipline and careful resource planning were essential to maintaining focus on value creation while preserving financial runway.

Challenges

As the organisation moved into later-stage clinical development, it faced the challenge of building out critical leadership and operational capabilities without over-scaling internal headcount. Several core functions required immediate attention, including Chemistry, Manufacturing & Controls (CMC), Clinical Trial Supply, Quality Assurance, and Clinical Operations.

The company needed to balance permanent leadership hires with specialist consultancy support, ensuring access to deep subject-matter expertise while maintaining agility. This support model also had to operate effectively across both the United States and the United Kingdom, aligning stakeholders, vendors, and regulatory requirements in multiple regions.

Solution

The first hurdle was to determine what would be required and the split between internal and external resources. Working with key stakeholders, we were able to understand the workload and timeline for certain key hires and where external consultancy support would be required to fill the gaps or bring in a variety of SME experience. The breakdown was as follows:

Consultancy Support

• Audit & Vendor Assurance (GxP)
  - Clinical & Manufacturing Vendors (CRO & CDMO/CMO)
  - Investigator Site(s)
  - System Providers
• Clinical Project Management
• Patient Recruitment & Vendor Oversight
• Pharmacovigilance
• Clinical QMS Development
• Drug/Device Auto Injector Expertise
• Clinical Trial Supply Support
• Clinical Scientist (Therapy area SME)

Permanent (FTE) Hires

• CMC Project Manager
• Clinical Project Director (x2)
• Director of Payroll
• Medical Director
• Clinical Trial Supply Manager
• VP, Head of Quality
• Associate Director, CMC Technical
• Executive Director Program Management

If you are facing a challenge and would like to speak to one of our specialists to find out how we can help, contact us today.

Email us: info@rrxco.com

Call us: +44 (0)1256 961 200