By Jennifer Maffia, Owner of Advanced Recruiting Partners 

FDA approval is one of the most celebrated milestones in biotech, and rightfully so. It represents years of research, clinical development, regulatory work, investment, and persistence. 

But from a talent perspective, I’ve always viewed approval a little differently. 

It isn’t simply the finish line. It is the point where an organization has to prove it is ready for what comes next. 

Replimune offers a timely example. On August 6, the FDA granted accelerated approval to TUDRIQEV™ in combination with nivolumab for certain adults with advanced melanoma following progression on an anti-PD-1-based regimen. With that decision, Replimune crossed an important threshold from clinical-stage biotech to commercial-stage company.  

And almost immediately, we could see what that transition looks like from an organizational standpoint. 

Approval Changes the Talent Equation 

Eight days after announcing the approval, Replimune said it expected TUDRIQEV to reach the market within 60 days. The company also announced the appointment of Michelle DiNapoli as Chief Commercial Officer, citing her more than 25 years of biopharmaceutical experience and, importantly, her previous experience building commercial organizations and launching oncology therapies.  

That is an important part of this story. 

When a biotech moves toward commercialization, its talent requirements change dramatically. The scientists, clinical researchers, regulatory professionals, and other experts who helped bring a therapy through development remain critical. But suddenly, the organization needs additional capabilities surrounding them. 

Commercial leadership, medical affairs, market access, pharmacovigilance, quality, manufacturing and supply chain, regulatory operations, patient support, and field-facing functions all become part of a much larger equation. 

For emerging biotechs, that transition can happen remarkably quickly. 

You Cannot Start Building at Approval 

One of the biggest mistakes companies can make is treating commercialization hiring as something that begins after regulatory approval. 

By then, the clock is already running. 

A company may need to educate the market, establish access and reimbursement processes, support physicians and patients, scale supply, meet post-approval obligations, and continue clinical development simultaneously. In Replimune’s case, the company is not only preparing its U.S. commercial launch but continuing the IGNYTE-3 confirmatory trial required as part of the accelerated approval pathway.  

That creates a very different workforce challenge than running a clinical-stage organization. 

The difficult question for leadership is when to hire. 

Build too aggressively before a regulatory decision, and the company takes on significant cost and risk. Wait until approval, and the organization may find itself competing for specialized talent precisely when it has the least time to spare. 

The answer is not necessarily hiring everyone earlier. It is developing the talent strategy earlier. 

Hire Against the Milestone, Not After It 

Companies approaching a major regulatory milestone should already understand which roles are mission-critical under each possible outcome. 

Who needs to be in place before approval? Which positions can be activated as confidence in the regulatory pathway increases? Which capabilities can initially be supported through consultants, contractors, or other flexible talent solutions? Where are the skills so specialized that building candidate relationships needs to begin months in advance? 

Those conversations belong alongside regulatory and commercialization planning. 

This is also where experienced talent becomes particularly valuable. 

A first-time commercial biotech is building infrastructure while simultaneously learning how to operate as a commercial organization. People who have successfully navigated that transition before bring much more than technical qualifications. They understand the pace, ambiguity, cross-functional dependencies, and pressure that accompany a launch. 

The difference between someone who understands commercialization theoretically and someone who has lived through a launch can be significant. 

Regulatory Readiness Is Also People Readiness 

There is another lesson in Replimune’s journey that I believe biotech leaders should pay attention to. 

The road to approval is rarely perfectly linear. 

Replimune received a Complete Response Letter from the FDA in April, resubmitted its BLA, received FDA acceptance of that resubmission in June, went through an advisory committee meeting in July, and ultimately secured accelerated approval in August.  

Talent strategies need to accommodate that uncertainty. 

Hiring plans cannot be so rigid that a regulatory delay creates an unsustainable organization, nor can they be so reactive that a positive decision leaves the company scrambling to build critical functions. 

That requires scenario planning, flexible workforce models, strong candidate pipelines, and ongoing communication between executive leadership, functional leaders, HR, and recruiting partners. 

The best time to establish those relationships is before they become urgent. 

From Scientific Success to Commercial Success 

For years, I have worked with companies and professionals across clinical research and biopharma, and one thing remains consistent: every major business milestone eventually becomes a people challenge. 

The science may earn the approval, but people determine what happens afterward. 

Replimune now describes itself as a “fully integrated biotechnology company” as it builds out the commercial infrastructure necessary to launch its first approved therapy. That evolution captures exactly why talent strategy should be part of commercialization strategy from the beginning. 

For biotech leaders approaching their own regulatory milestones, the question should not only be: 

Are we prepared to get this therapy approved? 

It should also be: 

If the answer is yes, do we have the people ready to take us into what comes next? 

Because FDA approval may be the moment everyone celebrates, but for the organization behind the therapy, it is only the beginning. 

About Jennifer Maffia 
With over 20 years of experience in clinical staffing, Jennifer Maffia connects pharmaceutical, biotech, and life sciences companies with top-tier clinical talent. She is known for building lasting client relationships, supporting tenured recruiters, and driving impactful hiring strategies. Through industry partnerships and active board involvement, Jennifer remains committed to advancing the life sciences field and improving patient outcomes.