You've just taken the job. Head of Medical Affairs at a biotech that's heading towards its first approval. The CEO shook your hand, said something about this hire being "critical to the next chapter," and then pointed you towards an empty desk. There's an empty budget line too. The clinical development team, who have been running this show for years, aren't entirely sure what you're supposed to do. Maybe there's a laptop waiting for you. Maybe not.
Welcome to the loneliest job in biotech.
I don't say that to put you off. But there's a conversation worth having early, because I've watched the same pattern play out too many times. The gap between what companies expect from their first medical affairs hire and what they actually give that person to work with is, frankly, huge. You were brought in to build a medical affairs function from nothing. But the company you've joined has spent its entire life focused on getting a drug approved. The culture reflects that. So does the budget. The meeting cadence, the vocabulary people use in the corridors, all of it orbits the clinical trial. And now you've turned up to politely suggest that approval isn't the finish line.
Good luck with that.
What follows is a practical framework for your first 100 days. I'm going to skip the part where I explain why medical affairs matters. You know why. It's presumably why you took the job. Instead I want to focus on how you actually build credibility, get infrastructure in place, and develop some strategic clarity before your company's world changes for good.
Most biotechs hire their first medical affairs lead too late. I realise that's a blunt way to open, but it keeps being true. A McKinsey survey of first-time launchers found that successful companies brought on key roles, including medical affairs leads, about four months earlier on average than companies that struggled. Eighty percent of the successful launchers said their timing was "just right" [1]. The general consensus in the industry is that you want your medical affairs foundation laid 12 to 24 months before anticipated launch [2].
Plenty of biotechs don't make this hire until the New Drug Application (NDA) or Marketing Authorisation Application (MAA) is practically being assembled. Then they wonder why everything feels reactive.
If you're reading this and you've already started, the clock is ticking. If you're a CEO reading this before making the hire, do it sooner than feels necessary. A few months of extra salary is nothing compared to a botched launch.
You can't fix what you won't name. So here's what you're actually dealing with.
You've inherited no evidence generation infrastructure. The company's entire evidence base was built for regulators. Efficacy in a controlled population. Safety in a carefully monitored cohort. Genuinely good work, the kind that gets you to a filing. But payers look at that data and it tells them almost nothing about real-world value. Community physicians can't see how the drug performs outside a trial protocol. HTA bodies running cost-effectiveness analyses are working with gaps everywhere. You're sitting on a clinical data package that answers one stakeholder's questions well and leaves three others mostly in the dark.
Your KOL network doesn't exist. The clinical team has relationships with trial investigators and steering committee members. Really valuable people. But they're not your network. You need community-based clinicians and payer-facing physicians. You need health economics and outcomes research (HEOR) researchers. You need patient advocates, the frontline experts who can tell you how your drug will actually get used once it's off-protocol. Nobody is going to build this network for you. You're starting from zero.
The organisation thinks you're here to manage publications. This one stings, I won't lie. You were hired as a strategic leader. But to a lot of your new colleagues, "medical affairs" means "the person who deals with manuscripts and answers medical information requests." You didn't take this job to spend your mornings chasing formatting corrections on abstracts. But that's the box you'll sit in until you actively change what the function means in people's heads.
Clinical development views you with suspicion. The overlap between late-stage clinical development and medical affairs is real. It's also largely unplanned. The clinical team owns the data, the regulatory narrative, most of the external scientific relationships. You need to take those things and redirect them towards post-approval realities, and you need to do it without looking like you're muscling in on years of hard work. Nobody planned this handoff. Until you arrived, there was nobody to hand off to.
Budget? What budget? The burn rate is focused on the pivotal trial, the regulatory submission, maybe early commercial planning. Medical affairs sits somewhere between "important" and "we'll get to that" on the CFO's list. You need to make a case for resources while delivering results with almost none. Every first MA hire I've spoken to knows that feeling well.
Nobody is going to hand you strategic influence. You have to take it. Diplomatically, yes. But firmly.
In your first two weeks, put a one-page medical affairs value map in front of leadership. Not a wish list for your department. What I mean is a clear, even blunt, articulation of the questions that your function answers and that nobody else in the building can. How will payers evaluate this drug? What does the post-approval evidence landscape look like, honestly? What are community physicians going to ask that the clinical trial data can't answer?
That document reframes how people think about you. You stop being "the publications person" and start being "the person who sees the questions we haven't thought to ask yet." We've discussed this shift in a previous piece on moving from clinical development to medical affairs. The move from "does it work?" to "how does it work in reality, and why should anyone care?" is a big one. Your value map makes it concrete for colleagues who haven't had to think about it before.
Before you build anything, you need to understand what you're working with. Take the clinical data package and look at it differently. What does it tell regulators? You already know that bit. But what does it tell payers? What about the community oncologist or neurologist who'll be prescribing this drug outside a trial? And what does it tell an HTA body?
The gaps will probably include HEOR data, comparative effectiveness evidence against real-world standard of care, patient-reported outcomes beyond what the pivotal trial measured, and long-term safety signals from real-world use.
This is where an Integrated Evidence Plan becomes genuinely useful. Not the bloated version, the six-month consulting exercise that produces a document nobody reads. I'm talking about the lean, dynamic kind that you can stand up in days. The kind that focuses on post-approval evidence gaps that actually matter. The 90/10 principle applies here. Ten percent of your evidence generation will drive ninety percent of the value. Figure out which ten percent that is, then fight for the resources to do it.
The clinical team's KOL relationships are a gift. But they won't carry you through what's coming next.
Trial investigators know controlled settings. You need people who know what happens at the point of care. Clinicians who'll actually prescribe your drug. Physicians on payer advisory committees. Health economists who do reimbursement work day in, day out. Patient advocates who live with the disease your drug treats and can tell you what the clinical endpoints don't capture.
Don't try to build a 200-person KOL map in your first month. Start with 10 relationships that actually matter. Share the emerging data with them, ask real questions about unmet needs in their practice, and mostly just listen. We've written about this before. The best insights come when you put clinical wisdom next to real-world evidence and let each one sharpen the other.
Start thinking about medical science liaison (MSL) needs now too, even if hiring is months away. Which geographies matter most at launch? Which accounts are highest priority? Sort that thinking out now and you'll save yourself a scramble later.
Nobody volunteers for this conversation. But it has to happen.
After approval, clinical development and medical affairs are serving different audiences. The regulatory narrative got the drug to this point, but payers and community physicians and patients are the audience now. They're asking different questions from the ones the agency asked.
You need the clinical team's cooperation. The best way to get it is to propose something straightforward: a joint evidence transition plan. Write down which activities stay with clinical development (regulatory commitments, post-marketing safety surveillance), which ones move to medical affairs (scientific exchange, HEOR, post-approval RWE generation), and which are genuinely shared (lifecycle data strategy, KOL engagement).
How you frame this really matters. The clinical team built something extraordinary. They got a drug from concept to approval. Your job is to make sure that work actually translates into impact in the real world, and you can't do that without them. I've seen this go badly when it becomes territorial. The biotechs that handle it well treat the transition as a continuum, both functions bringing different expertise to the same goal [3].
You're not getting a full team on day one. Accept that early.
But have a phased build plan ready. When the approval date gets close and minds start to focus (and they will), you want to be the person who already has a clear, justified roadmap.
First phase, pre-approval. That's now. You need fractional or outsourced support for medical communications and medical information. Publication planning, scientific content, a system for handling the medical enquiries that start arriving the moment the drug is approved. You can't launch without these things. The fractional model works well for biotechs at this stage, and more companies are going this route [4].
Second phase, around approval. Your first MSL hires. Focus them on the geographies and accounts that matter most for launch. These people become the scientific face of your company in the field. Hire for credibility and relationship-building ability. Therapeutic area knowledge matters, but it's not the only thing.
Third phase, post-approval. HEOR capability, whether you build it internally or work with a partner. More MSL coverage. Proper medical information infrastructure. This is where you're building for the long run.
When you're making the case to the CFO, talk about cost in their terms. Launching without medical affairs capability means delayed formulary access, weak payer negotiations, holes in your scientific communication. All of that costs more than building the function early [5].
Everyone in the building is focused on the approval milestone. Fair enough. But you should already be thinking about what happens after.
Post-approval evidence generation isn't optional. Phase IV commitments, safety registries, real-world effectiveness studies. These are increasingly conditions attached to your regulatory approval. The ICH adopted a reflection paper in June 2024 on harmonising real-world data and evidence use across regulatory agencies, with further guidelines in development [6]. As of 2026, both the FDA and EMA are pushing harder for post-marketing data than they were even five years ago.
But the regulatory side is only part of why this matters.
Post-approval evidence is a strategic asset. HEOR data is what gets your drug onto formularies and keeps it there. Comparative effectiveness research gives physicians a reason to prescribe your drug instead of what they were using before. Real-world safety and effectiveness data holds your market position and opens the door to label expansions down the line. We've written before about how the biotech playbook needs updating. Post-approval evidence strategy is one of the chapters most in need of a rewrite.
You, as the first medical affairs hire, can own this area before anyone else in the company even realises it needs owning.
No legacy systems. No entrenched processes. Nobody telling you "but we've always done it this way."
I know the blank canvas feels daunting. But it's also genuinely rare. You get to build a function from scratch in a company that's about to go through the biggest change of its life.
The biotechs that invest early in medical affairs and get their evidence strategy sorted before the approval letter arrives tend to launch better and reach patients faster [1]. That's not a coincidence.
This job is hard. It will be thankless for a while. You'll spend weeks explaining what medical affairs actually does to smart, well-meaning colleagues who've just never had to think about it. You'll fight for budget against priorities that feel louder and more visible. You'll sit in meetings about post-approval evidence where nobody thought to invite you.
That part gets better.
The medical affairs function you build in these first 100 days will shape how your company handles evidence for years. Get it right now and everything that follows gets easier.
Empty desk. Empty budget spreadsheet. Time to get started.
[1] McKinsey & Company. (2023). "Making the leap from R&D to fully integrated biotech for first launch." https://www.mckinsey.com/industries/life-sciences/our-insights/making-the-leap-from-r-and-d-to-fully-integrated-biotech-for-first-launch
[2] BioProcess International. (2023). "The Role of Medical Affairs in Moving from R&D to Commercialization." https://www.bioprocessintl.com/qa-qc/the-role-of-medical-affairs-in-moving-from-r-d-to-commercialization
[3] Inizio. (2024). "Six key elements for medical affairs in product launch planning." https://inizio.com/insights/six-key-elements-for-medical-affairs-in-product-launch-planning/
[4] Medical Affairs Professional Society (MAPS). "Small Team — Big Footprint: Building Global Medical Affairs with Lean Resources." https://medicalaffairs.org/webinar-small-team-big-footprint-building-global-medical-affairs-with-lean-resources/
[5] The Planet Group. (2023). "Hiring Timeline for a Successful Pharmaceutical Commercialization." https://www.theplanetgroup.com/blog/hiring-timeline
[6] ICH. (2024). "Reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines." https://www.ema.europa.eu/en/documents/other/ich-reflection-paper-pursuing-opportunities-harmonisation-using-real-world-data-generate-real-world-evidence_en.pdf