Expert insights contributed by managing directors Candice Cantelli Meklis and Ted Raad

There’s a moment every early-stage biotech leader knows, usually somewhere between a promising preclinical data package and the first IND filing, when the company stops feeling like a scrappy team and starts feeling like a real organization that’s about to get much more complicated.

That moment is exciting. It’s also where a lot of companies make decisions they spend the next three years unwinding.

We’ve lived through this phase more than once. The questions that seem tactical are anything but: Do we hire a head of finance now or wait? Should we build this capability in-house or find a partner? Are we actually ready to scale?  The answers shape your cash runway, your investor story, and your ability to execute when it matters most.

Hire for the Stage You’re In, Not the Stage You’re Aiming For

This sounds obvious. It isn’t.

In the run-up to an IND, the instinct is to start hiring the team you’ll need for Phase 2. You want to show investors a credible bench. But a senior CMO hired eighteen months before you have clinical data is a very expensive listener in a lot of meetings. A VP of Regulatory who’s built global dossiers may be overqualified — and frustrated — running pre-IND interactions with FDA. The mismatch is subtle at first, then it becomes a retention problem, then a leadership problem.

The better question isn’t who do we need eventually but instead what decisions do we need to make in the next twelve months, and who helps us make those well?

Pre-IND to Phase 1, that usually means a hands-on CMO who can own clinical strategy while wearing multiple hats; a finance lead who’s credible in front of Series A/B investors without needing a team underneath them; and regulatory and CMC expertise that’s fractional or partner-based rather than a full internal function.

Hire for judgment, not headcount. At this stage you need people who’ve done it before and can operate without much organizational support around them.

Know What to Build and What to Borrow

Every founding team has a natural instinct to build. We want control. And there’s a legitimate investor narrative around having key capabilities in-house. But in-house capability costs money and management bandwidth, two things almost always in shorter supply than expected.

Before Phase 1 data, there are very few functions where owning the infrastructure outright creates durable competitive advantage. Your edge is in your science, your clinical insight, and your ability to make good decisions fast.

Build in-house when:

☐  The capability is core to your scientific or clinical differentiation

☐  You’ll use it continuously, not in bursts

☐  The knowledge needs to compound inside the organization over time

Partner or outsource when:

☐  You need it now but won’t need it at scale for 18+ months

☐  The external market has deep capacity (biostatistics, regulatory writing, clinical operations)

☐  You don’t yet have the internal expertise to manage a full team doing it

CRO relationships fall into the second bucket, almost always at this stage. So does manufacturing, quality systems, pharmacovigilance, and in most cases, CMC. Where we’ve seen founders get burned is building a clinical ops function before they have a trial to run, or hiring a head of commercial two years before launch because the board wanted to see it.

Are You Actually Ready to Scale?

There’s a version of “scaling” that’s mostly just adding people. It looks like progress. But real scale readiness, the kind that holds up when Phase 1 data is positive and everyone wants to know what’s next, requires more than headcount growth.

Before scaling, check these four things:

☐  Decision infrastructure. Clear ownership at every level. When something goes wrong in a clinical study, there’s a single person accountable, not a committee.

☐  Financial controls that match your ambition. If your accounting is still running on spreadsheets, you’re one financing round away from a real problem. Get audit-ready earlier than you think you need to.

☐  Vendor and partner management discipline. Multiple CRO, CMC, and consulting relationships running simultaneously each need active governance to review deliverables, hold vendors to milestones, and escalate early.

☐  Culture that doesn’t depend on the founders. In a 15-person company, the CEO is the culture. At 40 or 50 people, they’re not. The values and operating norms need to exist somewhere new people can actually find them.

The Trap of Premature Scale

Companies that raise a large Series A on strong preclinical data often feel pressure from the board, from investors, and from their own ambition to quickly “build the organization.”  They hire fast, establish functions, build infrastructure. Within a year, G&A is consuming a meaningful share of burn. Then Phase 1 data comes back with a safety signal requiring a protocol amendment, and suddenly you’re managing a 45-person organization through a six-month delay with a runway that just got a lot more visible.

More people doesn’t mean faster.  In early-stage biotech, coordination costs grow faster than output.

Before every significant hire or function-build, ask: If we got a bad Phase 1 result tomorrow, would we still make this decision? If the answer is no, it’s probably premature.

The best-run pre-Phase 1 companies we’ve encountered are lean but not thin. They have the right people in the right seats, rigorous cash management, explicit choices about what they outsource, and boards that add real operational value. They plan in scenarios rather than pretending their operational plan is more certain than it is.

The goal at this stage isn’t to build the organization you’ll eventually become. It’s to make the right bets with the capital you have, generate the data that expands your options, and stay flexible enough to respond when the science surprises you, which it always does.