Hiring for FDA-Ready Clinical Teams: Common Mistakes To Avoid

As life sciences companies advance therapies through late-stage clinical trials, the need for FDA-ready teams becomes critical to their mission. However, even the most promising programs can face delays, or other issues, due to missteps in clinical hiring.

A compelling example: ImClone Systems and Erbitux faced significant hurdles in their filing for FDA approval of the monoclonal antibody Erbitux in the early 2000’s.

Despite promising early data and compelling clinical results, ImClone’s trial documentation and regulatory strategy was too weak to achieve the FDA’S approval.

Regulatory leadership was fragmented: internal experts lacked the strategic FDA-facing experience needed to assemble a compliant submission. Reliance on a CRO and external advisors wasn’t enough to fill the gaps.

Whilst ImClone later partnered with Merck KGaA, refiling a stronger submission and securing FDA approval in 2004, the delay cost them in both time-to-market and financial valuation. At the pivotal stage of hiring for FDA facing clinical teams, building the right team isn’t just important - it’s regulatory insurance.

 

Here are the most common mistakes hiring managers and recruiters should avoid when assembling FDA-facing clinical teams: 

1. Delaying Key Regulatory Hires

Companies often postpone bringing on experienced regulatory professionals until late in the process. This leaves critical strategy gaps in FDA engagement, IND maintenance, and submission planning.

What to do instead: Hire regulatory experts early—ideally those with successful FDA interaction history (pre-IND meetings, Type C meetings, NDA/IND/BLA submissions).

2. Prioritizing Technical Skills Over Strategic Insight

While technical competence is essential, strategic thinking is what gets products approved. Hiring purely for trial execution - without considering a candidate’s regulatory foresight - can hinder submission readiness.

What to do instead: Look for candidates who understand clinical strategy, risk mitigation, and the regulatory narrative - not just SOPs and timelines.

3. Overlooking Vendor Oversight Experience

Outsourcing to CROs and functional service providers is common, but managing those partnerships is a nuanced skill. Lack of oversight leads to compliance issues, missed milestones, and costly inefficiencies.

What to do instead: Ensure clinical leads have strong track records in vendor selection, budgeting, and governance. 

4. Ignoring Cultural Fit for High-Pressure Environments

FDA-ready stages are intense. Hiring someone with an impressive CV who struggles in agile, high-accountability settings can disrupt progress and morale.

What to do instead: Screen for adaptability, composure under pressure, and the ability to work cross-functionally in lean or fast-moving teams. 

5. Undervaluing Communication Skills

FDA interactions demand clarity, precision, and consistency. Teams that can’t communicate effectively - internally or externally - face greater regulatory risk.

What to do instead: Prioritise candidates who can translate complex science into regulatory-aligned language and who’ve been part of FDA-facing teams.

Final Thoughts

Hiring for FDA readiness is about more than just filling clinical roles - it’s about assembling a strategic, compliant, and communicative team that can withstand regulatory scrutiny. As specialists in life sciences recruitment, we help clients avoid these pitfalls by connecting them with proven talent who can bring both executional excellence and strategic depth.