Medical Affairs plays a pivotal role in driving success and advancing patient care. Recognising the significance of this function, pharmaceutical companies expect Medical Affairs to assume a leadership position.
Chris Toller, Medical Affairs expert and faculty member of CELforPharma’s The Medical Affairs Excellence Course, has built a framework for the development of Medical Affairs: the Domains of Medical Affairs Excellence (DMAX). At its centre is stakeholder engagement, which drives five surrounding domains: owning the data, communicating and educating, creating strategy built on insight, supporting the value proposition and leading the Medical Affairs function. Together, they set out what Medical Affairs managers must excel at to become true co-leaders in their organisations.
The transformative journey of Medical Affairs leadership offers unique opportunities, but also presents the challenge of balancing diverse demands and responsibilities. Medical Affairs managers are integral to both internal and external stakeholders, making their role even more vital, but also more complex.
Building a framework for the development of Medical Affairs
In this short extract from a recent webinar, Chris Toller explains why Medical Affairs teams benefit from having a clear and structured framework that defines their role and purpose.
As he introduces his model, Chris highlights the importance of first understanding what Medical Affairs is expected to do and how it contributes to the wider organisation. Establishing this clarity is the foundation for building a function that adds consistent, strategic value.
A central point Chris emphasises is the need to deeply understand the external people Medical Affairs interacts with. He stresses that appreciating who these individuals are, what challenges they face, and how they think is essential for developing meaningful, productive relationships. These one-to-one connections are not an end in themselves, they are the key to generating valuable insights that help the organisation better understand real-world needs and barriers. These insights enable Medical Affairs to guide internal decision-making with credible, experience-based perspectives from the outside healthcare environment.
This video introduces the first step toward building a coherent, future-ready Medical Affairs framework. One grounded in clarity of purpose, genuine external understanding, and the ability to capture insights that matter.
1. Maximise stakeholder engagement
At the heart of Medical Affairs excellence is stakeholder engagement. It sits at the centre of the framework because every other domain depends on it.
Medical Affairs professionals need strong relationships with key internal and external stakeholders, and a clear understanding of their needs and challenges. That understanding is the basis for clear, multichannel engagement strategies for each stakeholder group.
Medical Affairs also has unique access to physicians and patients. Used well, this lets it act as a peer-to-peer partner to external experts and help shape the practice of medicine.
2. Own the data
The second domain asks Medical Affairs to own the data. Medical Affairs professionals should be expert partners, with a detailed understanding of the science and data across products and therapy areas.
That means bringing therapy area and product data together in a central knowledge repository, and leading integrated evidence generation across phase IIIb/IV studies, real-world evidence and HEOR studies.
Owning the data also means making sure key data is communicated clearly and in context to all internal and external stakeholders.
3. Communicate and educate
The third domain is about bringing complex medical science to life.
Externally, Medical Affairs drives customer education on unmet needs, scientific innovation and clinical outcomes, including patient-reported outcomes. It also provides tailored information for patients and carers, helping them understand the burden of their disease and treatment and improving outcomes.
Internally, Medical Affairs makes sure teams have the therapy area knowledge and understanding to support every customer interaction.
All of this rests on rigorous standards of integrity. Medical Affairs builds credibility through quality and transparent communication.
4. Create strategy built on insight
True insight is critical to better decisions across the organisation, and Medical Affairs is well placed to provide it thanks to its privileged access to clinicians and patients. The fourth domain is about turning that insight into strategy.
It starts with defining patient journeys within target disease areas and highlighting the critical decision points along the way. Medical Affairs then continuously gathers insight into the needs, perceptions, motivations and behaviours of key stakeholders, distils it in context and shares it with the relevant partners.
The real value comes when that insight provides clear strategic direction, within Medical Affairs and across the organisation.
There is a risk, however, that the desire to gather more and more medical insights, and to capture them as yet another KPI, will erode their value. True insights are rare. They can't be mined like seams of coal, but must be sought out like diamonds.
5. Support the value proposition
The fifth domain is supporting the value proposition. It starts with understanding what value actually means to key internal and external stakeholders.
Medical Affairs helps ensure that data supporting cost-effectiveness is available at launch and throughout the lifecycle, and uses real-world evidence to support efficacy and value claims.
The aim is to demonstrate value to payers, physicians and patients, so that patients get better access to the best available treatments.
6. Lead the Medical Affairs function
Last but certainly not least, Medical Affairs leaders need to define the role of Medical Affairs within the organisation and create a culture for effective delivery of its objectives and ambitions.
That includes emphasising the strategic role of Medical Affairs, demonstrating its value so the function has access to the resources it needs, and attracting, developing and retaining the best talent and capabilities to deliver and sustain excellence.
Medical Affairs has evolved from a discipline driven by managing projects to one that is all about leading people. If the requirements on Medical Affairs teams are changing, then those teams, and the people who lead them, must adapt and flourish.
Taken together, the domains help Medical Affairs define its role, show its true value and raise that value within the organisation and across the profession. They also help address a long-standing challenge: defining KPIs that reflect real impact. Measuring the volume of activity falls short. KPIs should reflect the difference Medical Affairs makes to patient care, stakeholder satisfaction and overall organisational success.
Continue your learning from Chris
If you’d like to learn more from Chris, CELforPharma also offers a 2-day, hands-on course where you'll master the 6 keys to Medical Affairs success:
- Create strategy built on insight.
- Own the data.
- Communicate and educate.
- Maximise stakeholder engagement.
- Support the value proposition.
- Lead the Medical Affairs function.
The Medical Affairs Excellence Course
With Chris Toller
Don’t miss the latest insights from our expert faculty
Subscribe to our newsletter to:
- Stay on top of the latest expert insights
- Receive invitations to upcoming educational webinars
- Get updates on our courses and training programmes