A Seat at the Table with Chief Medical Officers


Interview with Klaus Dugi, Grainne Quinn and Wolfram Nothaft



As the influence and voice of medical affairs increases within pharmaceutical companies, the position of the Chief Medical Officer has emerged as one of the most crucial in the industry, leading the change towards transformative approaches to patient care. However, for many of those residing outside of MA’s walls, it can be hard to fully comprehend the key duties of a CMO, not to mention the experience needed to succeed in the position. Here, three CMOs share their different stories and offer insights into what it takes to be a CMO in pharma today.


Could you tell us your background and journey from where you started to where you are now?


Dugi: After finishing medical school in Germany, I spent 4 years as a Postdoc at the National Institutes of Health in Bethesda, Maryland, USA, conducting basic research in the field of atherosclerosis. Subsequently, I received further medical education at Heidelberg University Hospital in Germany, where I was boarded in Internal Medicine, Endocrinology, and Diabetology. My first role in pharma was in clinical operations, followed by positions of increasing responsibility in clinical development. I then became the Head of Global Medical Affairs before assuming the CMO role.


Nothaft: I trained in internal medicine in Germany, with the idea that I would stay in medical practice in a hospital setting and also continue work in clinical research. From my collaboration with pharma companies on research projects, I became very interested in a full-time commitment to clinical development. My previous positions provided me with an opportunity to gain experience in leadership and cross-functional collaboration. I was Head of Global Clinical Development at Shire when Takeda bought the company, and soon afterwards was offered the chance to lead a new function: the Chief Medical Office.


Quinn: Having completed my undergraduate medical degree in Ireland, I decided to go to the USA to do an internal medicine residency and I practised clinical medicine for a number of years there. I later returned to Ireland and took my first pharma industry role in Quintiles (now IQVIA) as a drug safety physician, where I gained experience in safety, medical monitoring, regulatory affairs, and clinical affairs. I later moved to a biotech company called Elan, which was subsequently acquired by Perrigo, and assumed the role of CMO here.


What are the key skills CMOs need to have in the modern, digital age?


Dugi: The key skills CMOs need have not changed over time and they relate to the ability to always put patients first, understand science, medicine, the benefit-risk ratio of medicines, and unmet patient needs. However, these days it will also be important to understand how modern tools such as e-Health, big data, real world evidence, and artificial intelligence can be utilised to more effectively interact with customers and gain insights.


Nothaft: Emerging technologies and rapid scientific progress afford unprecedented opportunities and challenges. But from my perspective, a lot of the skills a CMO needs are universal and timeless. Curiosity, the ability to adjust, continuous learning, leadership, cross-functional collaboration, and patient centricity are guiding principles that will always be of paramount importance. The pace of innovation and digitalisation is rapid but following those principles, especially patient centricity, will help any leader make the right decisions.


Quinn: The short answer is to be surrounded by a smart and digitally proficient team. If I was to pull out one thing it would be the ability to respond quickly in a potential crisis. In the current information age, the rapidity with which information circulates on products via consumer networks, regulatory authority platforms, and the media, having effective surveillance mechanisms on the external environment and the systems to respond swiftly are crucial to ensure that timely management and communication of factual data occur.


Has your role evolved since you first became a CMO?


Dugi: Absolutely! It has been almost 10 years since I first became a CMO and the environment has significantly changed since then. Today, CMOs must have a much better understanding of the needs of payers and how to address those needs with data on health economics, outcomes, and real-world settings. In addition, it is critical today to understand new tools such as social media, listening for early signal detection relating to drug safety, build patient-reported outcomes into clinical development, and adapt the drug development and medico-marketing approach to address recent advancements, such as gene therapy.


Nothaft: It evolves every day! Of course, a lot of evolution has come from the fact that the CMO role was recently introduced at Takeda. But beyond building the structure of a CMO position, we also see highly impactful changes and a more integrated and holistic way of thinking by incorporating new evidence generation approaches into our programmes. Employing new models of interactively generating and communicating scientific information, meaningfully engaging with external stakeholders, and consistently integrating patient input into our clinical development programmes, are also crucial ways the role has evolved. One thing that does not change, however, is our unwavering commitment to patient centricity.


Quinn: Fundamentally the role is about care. The consumer/patient/clinical trial subject is your business customer, and doing the right thing for that stakeholder group is core. What has evolved over time is the availability of information to that group. Therefore, our customers are well informed. In my organisation the self-care vision really embodies that same perspective.


What advice do you have for MA personnel who aspire to the role of CMO?


Dugi: Spend more time with your customers, (physicians, regulators, payers, patients) than with your colleagues, in order to get a better understanding of their needs and to be able to incorporate this into everything you do. Be open to learning about new developments but without falling victim to the hype and to be able to continuously put the patient at the centre of everything you do.


Nothaft: I believe that future CMOs can come from different backgrounds. CMO roles vary significantly from company to company, so don’t rule out that position even if your industry background isn’t wholly in MA. To me, the most important consideration for a CMO is being a physician with a broad skillset in pharma. The ability to collaborate, make difficult decisions, and explore uncharted territory is also essential. But underlying all of this is an unwavering commitment to our patients and keeping an independent voice in your organisation.


Quinn: The part that most prepared me is the number of years’ experience I had practising clinical medicine. Transitioning to pharma and being effective as a contributor in your designated role is clearly facilitated by that perspective. In addition, learn through the breadth of opportunities for physicians in the industry. To be an effective CMO, you need to develop a deep understanding of not only the medical affairs arena, but also of pharmacovigilance, regulatory affairs, clinical trial medical monitoring, clinical operations, as well as augmenting knowledge of business and finance.



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