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To help biopharma leaders navigate this new terrain, we interviewed 14 current or previous international/European general managers (GMs) and presidents with track records of successfully building out one or more organizations in Europe for US-based biopharma companies. Their insights offer biopharma leaders in the US considering EU/international expansion and incoming regional GMs a current perspective on buildouts in Europe, linking emerging strategic trends with their indications for how to attract the right talent.
Complex funding landscapes, economic uncertainty and shifting regulatory and market access dynamics have redefined the risk/reward profile for international growth. Traditional models centered on large-scale greenfield buildouts are now largely the exception. Instead, the industry is pivoting toward partnering and outsourcing along with hybrid market entry routes.
Decision-making cycles have compressed, with CEOs deferring major global investments until commercial viability is more certain in both home and overseas markets. The move toward delayed hiring and resource-light entries reflects the importance of flexibility and capital efficiency. While core teams keep getting leaner, market access and medical affairs have emerged as critical early priorities in light of the increased complexity and fragmentation of Europe’s regulatory and reimbursement environment.
The threshold for going alone in Europe is much higher than just a few years ago. Only the most well-funded companies with strong clinical assets — preferably targeting non-competitive therapeutic areas — pursue a direct build, while most others partner or forego international expansion entirely.
These structural shifts and smaller margins for errors have increased the importance of initial leadership and talent decisions. Companies must identify and empower leaders who can operate effectively in ambiguous, cross-functional settings and who have the credibility to build trust with headquarters and in local markets. The ability to foster a resilient, high-performing culture — often across dispersed, hybrid teams — has become a cornerstone of success.
“The risk profile and level of complexity for entering Europe has increased dramatically. While before it might have been the default to plan to go it alone in all the major European markets, it is now part of my role to ensure a sense of inertia, such that we only take the go decision once we are fairly convinced that we can achieve acceptable reimbursement.”
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Neil Hughes |
“Shaping the right approach requires assessing a number of key decisions that are company-specific, such as the competitiveness of the space and if it’s a drug targeting rare diseases. The type of investment and buildout will depend on that.”
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Margarida Duarte |
“There is not one single buildout scenario. Everything will be different: the company’s management, the patient scope, the treatment pathways and therefore the go-to-market strategy. You have to be adaptable and assess strategies case by case. Focus on leaders and companies with diversified cross-functional and full-cycle launch experience, from build-out to sustained in-market performance in today’s biotech space.”
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Alexey Kutahov |
“My advice to companies is to start early. The commercial team should be involved early in the development, no later than Phase II. Clinical endpoints with commercial relevance and assessing scenarios on the reimbursement options will decide the success of the launch.”
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Jean-Yves Chatelan |
Other points of view from the interviews
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The market entry formula has not drastically changed, but priority preferences for the EU4 (plus the UK) have evolved due to shifts in local regulation and reimbursement. Italy has climbed in priority, while the UK is often deprioritized amid a weaker risk/reward case and the hurdles that NICE presents. The “wave” launch strategy of targeting five countries simultaneously has almost completely disappeared. Germany remains the anchor market, and in a low-resource environment, some biopharma heads of international decide on the order of their next market entries based on the success of German launches. With the top five countries still representing approximately 80% of addressable opportunities in Europe, organizations are following a path of least resistance for entering additional markets, prioritizing pricing and ease of access.
Whereas pre-pandemic global buildouts often aimed to establish large-scale, specialized operations across multiple countries, organizations are leaner today, with increasingly cross-functional structures. At the beginning of a launch, European GMs prefer to build experienced, trusted core teams and often outsource country-level operations to consultants or market access agencies, benefiting from the increasing professionalism and sophistication in pharma commercial service companies. While remote and hybrid working models are now the norm, especially for country hubs, there is a growing preference for locating key positions at the European/international headquarters (typically in Switzerland) to foster direct engagement within the office and cultural cohesion.
Before the pandemic, many companies planned a European buildout 12 to 18 months before launch (and before submission of the Marketing Authorization Application), but nowadays the decision often is made just a few months in advance, without a definitive long-term plan. The need for speed and agility has transformed organizational design. International ventures are building for flexibility, favoring structures that can scale up or down quickly and that facilitate cross-functional cooperation from the outset. Cross-border collaboration and “no siloes” working are now non-negotiables, particularly in the early phases.
All leaders agree on the critical importance of establishing trust and a direct connection with the US-based leadership team. While European regional leaders often report to the Chief Commercial Officer (a much smaller number report to the CEO or sit on the executive committee), successful execution increasingly depends on cultivating strong relationships across the C-suite and board, often facilitated by frequent in-person presence at the US headquarters. It also remains the case that many US-based biopharma leaders may underestimate the regulatory and cultural differences in Europe, requiring international GMs to continuously communicate local specifics to maintain backing and alignment. Many leaders find that building early commercial momentum is closely tied to gaining support and a voice at the leadership table in the US.
Culture-building now requires a more intentional approach. While organizational culture still cascades from headquarters and the company’s mission, international GMs act as role models and “chief integrity officers,” responsible for articulating and demonstrating the culture, but not creating it alone.
“Balance optimism with reality. In biotech buildouts, you need to plan for the best and prepare for the worst. And forget the playbook; you will need to make your own choices at the right time, no matter if they are within or outside of the traditional pathway.”
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Lee Heeson |
“With European builds, you potentially manage up to 20% - 30% of the company’s product revenue but 70% to 80% of the complexity due to the diverse market realities, especially on pricing and reimbursement — educating US headquarters on the opportunities and complexities of the European commercial context and go-to-market options is critical.”
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Georg Pirmin Meyer |
“Differently from the large multinational pharma companies, in smaller companies there should be no siloes. You need to work cross-functionally, really collaborate. It’s necessary for understanding holistically the go to market approach which can be quite complex.”
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Petra Molan |
“At the end of the day, it’s a shared vision and the execution of it that drives the success. I’ve worked in many types of organizational models and reporting lines. What truly matters is accountability, collaboration among leaders and alignment around goals and expectations.”
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Orlando Oliveira |
“First of all, you should listen and deeply understand the culture of the company. It’s key to understand how the headquarters operates and how they will support you in your decisions. Without their backing you can’t be successful, so focus on listening before convincing.”
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Thomas Lackner |
Other points of view from the interviews
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Given that preferences are shifting toward smaller and more versatile teams, defining the right leadership profiles from the start is more critical than ever.
All the leaders we interviewed acknowledged that at inception, the cultural fit, a sense of urgency and authentic adherence to the company’s mission are more critical than technical skills. They prefer adaptable, hands-on leaders who can operate successfully in lean, cross-functional environments and who bring both loyalty and intrinsic motivation beyond title or compensation. Operational agility is a must, as is the ability to wear multiple hats and pivot as business needs evolve. These qualities have become more valuable than deep therapeutic-area expertise for most roles outside highly specialized launches.
Market access and regulatory experience have risen in importance, with early hires expected to drive country readiness and navigate an increasingly complex market landscape. Many leaders emphasize the need for a balanced skill set across commercial, access and medical functions to ensure integrated execution. Leaders are expected to deliver from day one, leaving little room for on-the-job learning at the senior level.
The order in which positions are filled reflects this reality. Medical affairs and market access are typically the first hires, often followed by finance and HR to ensure an operational foundation. Commercial teams are built out later, post-access, with flexible and hybrid models emerging to bridge traditional siloes within the customer-facing functions. Outsourcing remains viable for early launch phases, particularly for support and field-facing roles. For single-asset or resource-constrained launches, organizations may start with only a medical or access lead, deferring full buildouts until the business case is proven.
Finding talent has become more complex and more nuanced. While there is an abundance of available talent, particularly post-pandemic and with restructuring at many global large cap biopharma companies, securing top-tier market access and regulatory personnel can remain challenging, especially because of lean HR teams and a large number of applications. Companies increasingly rely on executive search partners for key roles and panel-based, cross-functional hiring processes to identify entrepreneurial and adaptable leaders and to filter out cultural mismatches. Hybrid and remote work have enabled global “talent arbitrage,” allowing organizations to hire for expertise rather than location. Remote work also has increased the need for strong onboarding and integration into the culture.
Ultimately, success in the current environment depends on assembling small, high-trust teams with the versatility to navigate ambiguity, the resilience to adapt to rapid change and the operational discipline to deliver early commercial momentum with limited resources. Given the tight timelines, international GMs often bring in trusted former colleagues, but they are increasingly tapping new people, benefiting from a broader and high-quality talent pool.
Other points of view from the interviews
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“The perfect profile for someone doing a startup biotech is someone who has done Big Pharma and then moved to a small to mid-sized enterprise. That combination is the winning combination for me, because they know what structure looks like but can already perform in a low-structure environment.”
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Samer Saadeh |
“In this kind of project, you never know what’s going to happen tomorrow and you need people who are confident and who are able to pivot as the scope changes. Being adaptable, resourceful and willing to roll their sleeves up to capture opportunities and reduce risks for management is key.”
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Laura Genatossio |
“There are two sources of talent right now: one consisting of very experienced executives with extensive large pharma experience and some biotech exposure, and a second consisting of young talent from smaller companies but with a contemporary, innovative and tech-first approach, often bringing in a dynamic, multi-cultural mindset.”
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Anant Murthy |
“Hire the right talent for the right job, irrespective of prior relationships, etc., and make sure they're up for the challenge. Some leaders hire teams that they've worked with in the past while others opt for a conglomerate. I prefer the latter — you might want to enroll one or two people you trust from the past into the new journey, but every situation is different and no one team can be transplanted into another company and thrive.”
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Sebastian Stachowiak |
“Always start with people. Surround yourself with people with the right expertise and, especially, with good heart. You will go through a lot, and you need colleagues with intrinsic motivations beyond money and who can play as a team.”
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Gerwin Winter |
Expanding into new geographies reflects not just commercial and financial considerations but the long-term strategic ambition of boards, CEOs, CCOs and founders.
The most successful buildouts are lean, pragmatic and anchored in a clear-eyed assessment of where resources will have the greatest effect. Companies must recognize that European/ international launches demand patience and scenario-based decision-making, and that buildouts planned with limited time before a product launch may affect the size and speed of the return on the investment, as some regulatory timelines cannot be compressed.
Building and maintaining trust with international leadership teams is critical; this includes regular in-person engagement and a willingness to grapple with the operational complexity of the region. Above all, US-based leadership must set realistic expectations with stakeholders, create space for local leaders to adapt the strategy as market conditions evolve, and ensure that the company’s ambitions in Europe are matched by credible, long-term investment.
Prospective International/European Presidents/GMs should treat every opportunity as a two-way assessment. Remember that no two launches are alike. Scenario planning, flexibility and willingness to course-correct are key. What worked at one company may not work at another, even with the same leader.
Run your due diligence on the organization’s credibility: scrutinize the pipeline assets, the competitive landscape in Europe within the target therapeutic spaces, funding, leadership alignment and philosophy and the company’s commitment to its European ambitions. If the vision or resource allocation is unclear, or if headquarters underestimates the complexity of Europe, the misalignment risk will be high. Pressure-test the business case yourself rather than relying solely on headquarters’ projections. The business plan must become your own.
When starting your new assignment, resist the urge to overbuild. Focus on hiring a small, high-impact team, blending trusted partners with new people from a rich talent pool. Stay ahead of not just regulatory and sociopolitical trends, but also technologies such as artificial intelligence, new ways of optimizing processes and ways to minimize operational costs.
Be transparent about what you can and cannot control, and set clear expectations with headquarters from the outset. Invest early in peer networks and cross-functional collaboration — success is rarely achieved in isolation. Remain humble, adaptable and prepared to pivot as circumstances change; leadership in Europe today is defined as much by resilience and realism as by ambition. Above all, remember that credibility with headquarters and early commercial traction are the strongest currencies for future growth.
Patrick Mooney co-leads Russell Reynolds Associates’ Global Biopharma practice.
Alessandro Melloni is a member of Russell Reynolds Associates’ Healthcare Knowledge team.
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