Building Clinical R&D Teams for Global Oncology Expansion

The challenge

A leading biotech company was preparing to transition from Phase 2 to Phase 3 for a global oncology program, a critical milestone requiring robust internal capabilities ahead of an anticipated IPO announcement later this year. This expansion posed three major challenges:

1. On-site work requirement – limiting flexibility and reducing candidate interest in a market increasingly favoring remote or hybrid roles.
   
   
2. Insourced trial design – unlike many peers who outsource to CROs, this company needed internal expertise to manage complex oncology protocols, adaptive trial designs, and global regulatory requirements.
   
   
3. A saturated talent pool – most qualified candidates had already been approached by other agencies, making engagement and differentiation essential.

The company had worked with multiple vendors but struggled to achieve the speed, volume, and niche delivery required for this pivotal program.

Solution

We partnered closely with the client to understand their scientific and operational priorities, including the need for expertise in oncology trial endpoints, biomarker-driven patient stratification, and global regulatory compliance. Leveraging our deep network and consultative approach, we delivered 25 key hires within 12 months, including:

• 15 Clinical Operations professionals (CTMs, CPMs, Site Monitors, Director of Clinical Operations)
• Strategic hires in Regulatory Affairs, Biometrics, Pharmacovigilance, Medical Writing, and a Director of GCP Compliance

Our ability to combine speed, quality, and market insight allowed us to outperform previous vendors and secure talent others could not, which is critical for scaling internal capabilities without reliance on CROs.

Impact

The client successfully built an internal clinical R&D infrastructure, enabling them to:

• Accelerate Phase 3 trial timelines globally
• Maintain full control over study design and execution
• Ensure compliance with ICH-GCP standards and global regulatory frameworks
• Advance a high-profile oncology program toward pivotal trials
• Position themselves strongly for a successful IPO
  
  

This strengthened their position as an innovator in oncology and ensured readiness for late-stage development.