What Commercial Roles to Hire Between Phase 3 and PDUFA
By Travis Sjursen, Founder, Permanent Solutions Group
The window between a positive Phase 3 readout and your PDUFA date is when launch success gets decided, and most of the deciding is done by people you haven't hired yet. Here's the commercial build sequence I've watched work, and fail, over 20 years of staffing these launches.
The sequence that works
18 to 24 months before approval: Chief Commercial Officer or VP of Commercial. Your first commercial hire sets the strategy everyone else executes. Companies that hire this seat late end up with a launch plan written by consultants and owned by no one. If your Phase 3 data is strong enough to raise on, it's strong enough to hire on.
15 to 18 months out: Market Access lead. In specialty and rare disease, access is the launch. Payer value story, pricing strategy, hub design, and distribution decisions all have long lead times, and payers won't wait while you staff up. I'd argue this hire matters more than any other on this list, and it's routinely the one companies delay.
12 to 15 months out: VP of Marketing. Disease-state education, positioning, patient-finding programs, and congress presence need runway. By the time you're inside a year, this person should be building, not onboarding.
9 to 12 months out: Medical Affairs alignment and Commercial Operations. MSL teams typically deploy pre-approval under medical, but commercial needs its operations backbone now: data, CRM, incentive design, territory analysis. One strong Commercial Ops director prevents a hundred launch-week fires.
6 to 9 months out: Sales leadership. VP of Sales or National Sales Director first, then region leaders. Rep hiring timing depends on your label confidence and cash runway; in rare disease with a concentrated prescriber base, a small institutional team hired close to approval often beats a big early build.
What this costs and why it's worth it
A pre-revenue commercial build of five to eight leaders is real money, often several million dollars in fully loaded comp before a single script. Boards feel that. But the math on waiting is worse: every quarter of delayed uptake on a specialty product is typically worth far more than the comp you saved, and access windows with payers don't reopen on your schedule.
The mistakes I keep seeing
- Hiring sales first because it feels like commercialization. Reps without access and positioning are expensive passengers.
- One "head of commercial" expected to be CCO, access lead, and marketer simultaneously. That works until roughly 12 months out, then it visibly doesn't.
- Waiting for the PDUFA date to be assigned before starting searches. Executive searches take 60 to 90 days. Start from your readout, not your acceptance letter.
- Underweighting stage fit. Big-pharma launch veterans who've never worked without infrastructure are the most common mis-hire in this window.
Frequently asked questions
- When should a biotech hire its first commercial employee?
- For a specialty or rare disease launch, the first commercial leader should typically start 18 to 24 months before anticipated approval. Earlier if your access story is complex.
- Should we build the commercial team before or after the PDUFA date is set?
- Start your leadership searches at the Phase 3 readout. Waiting for FDA acceptance costs you a quarter you'll want back at launch.
- How big should a rare disease launch sales force be?
- Often far smaller than instinct suggests. With a few hundred relevant prescribers nationally, teams of 10 to 30 focused, senior reps frequently outperform larger builds.