Between a promising preclinical package and a filed IND sits a demanding stretch of work: GLP toxicology, drug substance and drug product manufacturing, a first-in-human protocol, an investigator's brochure, and a regulatory strategy that holds them together. Most companies cannot hire for all of it at once. The real question is what to hire first.
A useful rule is that every hire before the IND should either remove a risk from the critical path or make that risk visible sooner. Roles that do neither can usually wait, or can be covered by consultants and partners until the program is further along.
Start with the critical path, not the org chart
Founders often sketch the team they want once the first trial is running and then hire toward it. The result is a top-heavy team with gaps in exactly the places that delay filings. Start instead from the IND timeline and ask where the program is most likely to slip.
For many programs, the honest answer is manufacturing and toxicology. Those workstreams have long lead times, depend on external partners, and are difficult to recover once they fall behind. The clinical protocol can often be drafted later in the process, though it should never be rushed.
Every hire before the IND should either remove a risk from the critical path or make that risk visible sooner.
The first wave: owning the IND
The first three or four hires should be people who can own the core sections of the submission and manage the external organizations doing much of the work.
- A regulatory affairs lead who can build the regulatory strategy, prepare the pre-IND meeting package, and coordinate the submission.
- A CMC lead with experience in your modality, who can manage a CDMO, oversee process development, and anticipate what FDA will ask about the material going into patients.
- A nonclinical or translational lead who can oversee GLP toxicology at a CRO and connect the findings to a defensible starting dose.
- A program manager who holds the integrated timeline and makes dependencies between workstreams visible to the CEO and the board.
The program manager is the hire most often deferred and most often regretted. Without one, scientific leaders spend their time reconciling schedules instead of solving problems.
The second wave: from protocol to study
As IND-enabling work matures, the emphasis shifts toward the clinic. Hires five through eight typically begin with a clinical development or medical lead, whether a first CMO or a senior medical director, who owns the protocol and the clinical development plan. Alongside them comes a clinical operations lead who can select and manage a CRO, plan site activation, and build a realistic enrollment strategy.
This is also the moment to bring in quality assurance. A quality lead fluent in GxP protects you from findings that are inexpensive to prevent and costly to remediate, and gives your CDMO and CRO a counterpart who will hold them to standard. A clinical scientist rounds out the wave, supporting the medical lead on protocol development, investigator's brochure content, and eventually data review.
The third wave, and what to keep outside
The ninth and tenth hires depend on the program. For many teams, the right choices are a drug safety or pharmacovigilance lead, to prepare for adverse event reporting obligations once dosing begins, and a clinical data management or biostatistics lead, to oversee vendors and make sure the data will answer the questions the trial was designed to ask.
Some functions are often better left with partners at this stage. Medical writing, statistical analysis, safety database hosting, and site monitoring are commonly outsourced to CROs and specialist firms. The key is to outsource the work, never the oversight. Every external workstream needs an internal owner who understands it well enough to notice when something is going wrong.
Two final cautions. First, match seniority to the stage. A leader whose recent experience is running a large department at a commercial company may struggle in a role where they are also the person writing the document. Second, interim and fractional leaders are a legitimate bridge, especially in regulatory and CMC, but each arrangement should have a defined scope and a plan for transition.
A well-sequenced team does not guarantee a clean IND. It does mean that when something slips, and something usually does, the people who can fix it are already on the team.
