Previously

Susan is the new Global Head of Medical Affairs of a small US based company with one product on the US market. The company is expanding to Europe and opening offices in selected locations; but there is currently no European footprint.

The first launch is planned in 12 months. Susan’s task? Design and implement a functional Medical Affairs set-up to support product launch. When we last saw Susan, she had put together an initial task list, started assessing key topics and initial planning (here). Today, Susan shares her plan with her boss Mark, who is just back from his holiday in Europe, and discovers how much is moving in the background as the company prepares for launch.

Susan Buckets her List

Susan has evolved her list and identified key people to talk as she consider Medical Affairs in Europe in preparation for the launch. She has allocated key topics to three buckets: Understand, Design and Build – as she prepares to talk to Mark.

Understand

• Commercial strategy, connections, launch sequence and competitors
• Market access and pricing
• Sales set-up and hiring approach
• Regulatory considerations
• Individual market insights – healthcare systems, current KOL relationships etc.
• Which clinical trial sites were used in Europe, who were the involved investigators, how did the trials perform at the sites and where does the company have strong relationships with investigators. Who currently “owns” those relationships?
• KOL engagement approach and appetite – who’s open to advisory boards, trial participation, RWE collaboration
• Data catalogue what data does the company have available on markets, KOLs, demographics etc.
• Scientific communications approach in the US, what can they share for Europe?
• Medical information approach, what is US standard, what can we reuse for ex-US?
• Compliance/legal landscape: what applies, what’s already in place, or planned?

Design

• Minimal build requirements for European build and scale-up
• Systems – what is planned, what needs to be considered for Med Affairs
• Roles – who does what – global, regional, local
• Interdependencies with other market facing roles, IT, and pharmacovigilance
• Processes and governance and compliance approach

Build

• EU KOL identification, and market understanding and market approach for at least the first market
• KOL engagement plan and potential future trial/RWE opportunities per market
• Scientific communications approach and engagement tailored to Europe
• Digital strategy and omnichannel engagement working across functions
• Compliance framework: digital, GDPR, content creation, customer engagement, AI
• Medical Information and content tailored to the European markets
• Sales training and engagement and materials
• Integrated IT approach for tracking, data analytics, PV integration, content management

While Susan understands the product well, having worked on the Phase III trials and as a Medical Director in the US market, she also knows there is a lot she doesn’t know as she plans the set-up for Europe. As her awareness builds of everything that needs to happen in the next 12 months, she feels slight apprehension at the sheer scale of the task considering the timelines.

Comments on LinkedIn confirmed that Susan’s situation is challenging.

Is Susan’s Situation Impossible? The Experts Weigh in

There were two main responses to Susan’s predicament: empathy, and the observation that pragmatism beats perfectionism.

Dr Myriam Cherif, a US based Medical Affairs Advisor, said, “I can see poor Susan running like a headless chicken” – luckily, Susan is experienced and she has a plan, so she is currently still quite collected. However, a lot of what she needs to address is not in her control, so let us see what happens next.

Dr Forooz Soroor, a Medical Science Liaison working in women’s health said, “Great reminder that success in Medical Affairs isn’t about having a perfect plan, it’s about asking the right questions early and staying adaptable.” Highlighting that taking steps forward is typically preferable to standing still and overthinking. In Susan’s situation everything for Europe is evolving, the commercial operations set-up, IT build and decisions etc. so every day the situation is changing and that will influence what Susan does next too and how she approaches the situation.

This is reflected in Dr Elsa Zekeng’s observation “One theme running throughout Susan’s journey is that timing and sequencing matter as much as structure. The strongest Medical Affairs organisations are rarely those with the most detailed plans, but those that recognise dependencies early and evolve deliberately as evidence, relationships and local knowledge develop.”

Dr Maaike Addicks, MD, Medical Affairs Expert and MSL trainer, combines empathy with practical solutions in her response, but she doesn’t have high hopes for Susan’s success “I’ve had time to consider, and can I start with saying that I feel bad for Susan. This is too much for one person! Not only the workload but also the very different capabilities she is expected to have; building relationships, understanding IT, dealing with science and different cultures and authorities and and and….She needs help. A lot of help. I’m hoping for her sake there’s already some sort of local MSL presence that she can use to help her start building the KOL network and bringing in insights to inform strategy. (Authors note – there is not). And this leads to something else: Susan will fail completely if she does not succeed in building a strong internal network and goodwill. She’ll need a lot of that, because she’s going to need a lot of willingness to work with her and change. (Which is more your expertise than mine Dr Isabelle Widmer)”

My reflections are that Susan’s challenge is significant but doable, provided, as Maaike Addicks says, she has help and leadership support. Does she? Let’s find out.

What Will Make Susan Successful in This Situation?

Start Without a Perfect Plan

Susan’s situation is challenging, and she’s only just getting started. The experts above made a critical point: she can, and should, start before she has a perfect plan. She can’t implement without a confident assessment – but once she has an approximate approach, she can begin initiating connections, engaging stakeholders, and gathering information. Her plan will be iterative. There’s no other way

Susan has to accept she won’t know everything – and cannot predict everything

Pick a Thread and Pull

It is true that timing and sequencing are key, but this becomes apparent once you have started engaging, and there is no perfect place to start. It is like unravelling a big, messy ball of wool with lots of threads, you just have to start somewhere.

However, success can be predicted and it depends on these three factors:

1. The ability to identify what is critical, what is nice to have and what can be postponed and the confidence to act upon your insights.
2. Knowing what questions to ask, who to go to and accepting you will continually be surprised, and that that is ok.
3. Access to a support network of peers, senior leaders, mentors, coaches, or consultants who can help you.

Susan has industry-wide experience, and many friends in European Medical Affairs roles, although none of them have built it from scratch, as she is about to do and she has worked with consultants in the past and is considering hiring in additional support as she maps out her approach.

Give People the Job, Not Just the Title

The ability to know what matters in a project this complex is born of experience. Making things happen fast, though, depends on something else: a strong internal network that pre-exists the project.

In small companies, with little redundancy in skill sets, it’s imperative the right people are in place, experienced, level-headed, pragmatic, flexible. But that’s not enough on its own: they also need the authority to actually do the job.

There are many ways to achieve results. There’s one reliable way to fail: giving someone accountability without giving them the authority to act on what they know.

Susan, luckily, is experienced and level-headed. She’s done the groundwork. Now it’s time to bring it to Mark.

The Rubber hits the Road – Susan Outlines an Approach

Susan knows she will need help, a lot of help. In preparation for her meeting, she lists her key points. Knowing the budget challenges, she will propose a small core team comprising a digital lead, an EU Medical Affairs Leader, and a programme manager supported by experts from the wider organisation.

• Named representatives from every involved discipline, including EU leads where already available:  R&D, IT, compliance, commercial, regulatory affairs, scientific communications, market access, and country teams.
• A digital lead to ensure Medical is looped in on websites, content, inbound enquiries, and any IT systems – before they go live, not after.
• An experienced programme manager to manage the plan, track contingencies, and keep the team and information flowing.
• A Medical Affairs Leader for Europe, with real credibility in the region and deep insight into market dependencies, compliance, local regulations, and medical associations.

She knows she also needs a lot of help for scientific communications, and she will approach the US lead for support on this.

Going into her meeting with Mark, Susan is confident. She has an approach, and she has also identified potential candidates; Vilma, an internal Finnish candidate for the programme manager role, and Giovanna, an Italian with decades of regional experience in Medical Affairs and Compliance, who is looking for a new challenge following a reorganisation.

She feels well prepared.

Susan Meets Mark – Reality Meets Clarity

Mark Loves Europe

Mark just got back from Europe. Susan is excited to share her progress but first she wants to know how he liked Europe.

Mark says “It was fantastic. We biked in Provence – so gorgeous – the hills, the vineyards, the beautiful villages, with their village squares and churches, the food markets – and the food it was divine. Then we went to Italy, Campania, gorgeous landscapes, seafood, the beaches, the weather. Everyone seems to live outside in the summer. Then we drove through Switzerland and flew home out of Zurich. The country is small but amazing. The mountains and the lakes are gorgeous, and it is so clean, you can swim everywhere. The hikes are spectacular and they speak four official languages, can you imagine?”

Susan smiled and said, “That sounds like a fabulous trip, what did you enjoy most?”

Mark answered “Honestly? The diversity was incredible, the fact you can drive a couple of hundred miles and suddenly the landscapes, the language, the food, the culture, and customs change dramatically. I really enjoyed that; I can’t wait to go back. I’d love to go to Croatia, I’ve heard it is gorgeous”

Susan is happy that Mark has come back in such high spirits and enthusiasm for Europe and feels optimistic that he will support her ideas.

Susan Makes Her Case

Susan knows Mark is under time-pressure, so she has a short presentation planned to outline her thoughts, which she also sent him upfront. She gives Mark a quick intro, sharing that she will cover the list, a rough timeline and headcount.

Mark says “Sounds great, I’m all yours, I can give you 30 minutes”

She gives him a quick overview. Mark agrees with her general approach. He is supportive of her getting additional help, and when she asks which country will launch first, he tells her: Germany.

Susan is feeling good. “Great to know I have your support. I want to connect with R&D to find out where they ran trials in Europe, who the investigators were, and who owns those relationships now. I’ve also got two potential candidates for the open positions: Vilma, a Finnish programme leader, she is internal and based here in the US and Giovanna an Italian based in Europe, she is super experienced and looking for a new job”

Mark says “Oh, I’ve got great news, I see how fast you are moving, I have two candidates for these roles already, I found them when I read your slides – there is a junior programme manager in our Mumbai team, HR suggested we try him out, and Alex. You may know him? Physician, regulatory affairs background? We can have him immediately on secondment, they just reorganised the team. He is European too, so that fits”

Susan’s heart sinks “Thanks so much for this, but may I speak frankly?”

Mark nods. Susan says “I am sure these are great candidates, but I only have 12 months. You’ve just seen how different every market is, that’s why I want a team who understands European Medical Affairs. I’d want them to bring knowledge and to be self-starters and self-sufficient. Of course I’m happy to take your candidates, we need all the help we can get, but can I also hire someone with specific experience?”

Mark looks disappointed, he says “You know Susan, you are overcomplicating this. We are starting in one market, we have time to build the entire region, we just have to get Germany right. Also, our US approach is pretty air-tight, we can surely copy-paste a lot of what we do in the US to Europe? The two candidates I mentioned I know you can train them up. And my hands are tied. Why don’t you see how you go, and we can revisit later, ok? You are free to identify the digital lead.”

He adds, “I picked you because you are competent, experienced, and you have high standards. But we have tight timelines, we need speed over perfection here. I know it may be hard, but you may have to adapt a little. But I know you can succeed; you have my support – don’t disappoint me!” He smiles.

Susan is gutted, but she thanks him for his time. On her way out she remembers the compliance framework. She asks Mark who to contact. He says the US compliance lead should know what the global approach will be. He adds “Why don’t you do a first pass using AI, it’s incredible what it can do, it should be able to give you an overview for Europe pretty fast”

Susan nods.

One Last Surprise

Susan is at the coffee machine reflecting on the situation and what to do next when Mark walks in.

He says “I hoped I’d find you here, I’ve got some more good news. The new German General Manager Hans-Jörg, an old friend of mine, has just come on board. Hans-Jörg tells me he is in the final stages of hiring his Medical Affairs Director and two MSLs, so you will soon have a team to work with there!”

Mark beams at her

He adds: “You are doing a great job, I am so glad I promoted you, don’t hesitate to come to me with any issues, you know I will always help, we really need to get this right and you have my full confidence”

Susan heads back to her desk. She’s going to need a strategy and more help than she has.

Susan Reflects

Susan is back at her desk. The meeting didn’t go as planned. She has two new hires, but neither has Medical Affairs experience. Meanwhile, in Germany, Hans-Jörg is already building his own team before she’s even had the chance to put a structure in place for him to build into.

She’s also facing another challenge. If she doesn’t deliver, she’ll look like the wrong hire, even though she knows she has identified all the challenges correctly and the issues she has highlighted are not perfectionistic but derived from experience. If she does succeed with junior, and inexperienced support she’ll have proven, unintentionally, that none of this ever needed more resource in the first place.

She feels deflated.

If this resonates and would like to set-up a short 30-minute chat with me, bring your problem, and I will give you my take: here

I write regularly on global transformations, medical affairs, medical information, healthcare, pharma, AI and sign up for my bi-weekly newsletter here