Research and development: Innovation needs leadership

Research depends on openness. Development requires decisions. Between the two lies a leadership task that is particularly demanding in the healthcare market: scientific hypotheses must be examined, resources must be prioritized, regulatory requirements must be taken into account at an early stage and different disciplines must be combined into a common development path.

R&D organisations are under increasing pressure. Technologies are evolving rapidly, data volumes are increasing, clinical and regulatory requirements remain high, while capital and specialized talent are limited. A strong pipeline is therefore not created by as many projects as possible. It arises through clarity about which programs are continued, developed or terminated in partnership – and through a culture in which bad news can be visible early on.

Europe has excellent science, skilled professionals and efficient industrial structures. At the same time, the global balance of forces is shifting. According to the EFPIA, pharmaceutical R&D spending increased more slowly in Europe than in the US between 2010 and 2022 and significantly more slowly than in China. [1] This is not just a question of the volume of investment. It is about speed, framework and the ability to transform research into clinical development and scalable products.

For Germany, the joint strategy paper by vfa and Fraunhofer Health describes fields of action ranging from research infrastructure and digitalisation to translation, regulation and patient participation. [2] This makes it clear that innovation does not depend on a single function. It arises in a system of science, development, approval, production, market and supply.

Managers in this environment must understand the external location dynamics and at the same time remain capable of acting in their own company. Neither a reference to difficult framework conditions nor hectic reorganisation replaces clear portfolio decisions.

R&D portfolios always contain uncertainty. Early data is incomplete, technical risks are changing and a promising approach can fail in efficacy, safety, manufacturability or reimbursement. Good leadership does not try to smooth this uncertainty linguistically. It makes assumptions, decision rules and abandonment criteria transparent.

Priorisierung braucht vergleichbare Kriterien

Programmes must not be assessed solely on the basis of internal enthusiasm or historical investment. Scientific differentiation, clinical needs, developmental risk, regulatory pathway, intellectual property rights, manufacturability and commercial potential belong in a common picture. Only then can it be decided where own resources make the greatest contribution.

Quitting is a Leadership

Stopping a project protects capital and creates capacity for better options. Nevertheless, weak programs are often continued for too long because teams are emotionally attached or an end is considered a personal failure. A robust R&D culture separates scientific knowledge from the duty to defend every project to the end.

McKinsey describes dynamic resource allocation, clear governance and conscious choices between in-house performance and partnerships as core elements of a stronger pharmaceutical R&D operating model. [3] The organizational form is not an end in itself: it must enable better decisions.

The most difficult route often begins where a scientifically convincing approach is to be transferred into a reproducible development process. Preclinical outcomes, clinical design, biomarkers, quality, production and regulatory strategy must fit together early on. If these perspectives are only switched on one after the other, late loops and avoidable risks arise.

In its regulatory science strategy, EMA explicitly combines new technologies, collaborative evidence generation, patient access and regulatory science. [4] For R&D management, it follows: Regulatory Affairs and Quality are not downstream control bodies. They belong at the table when development paths and data strategies are defined.

• Define clinical or care-related benefits early and concretely.
• Clarify evidence requirements, endpoints and data quality before critical investments.
• Development, regulatory, quality and production lead to joint milestones.
• Risiken offen eskalieren, bevor Zeitdruck sie unsichtbar macht.
• Integrating patient and user perspectives into development logic.

Especially in biotech, this integration capability determines whether the transition from a scientifically shaped organization to a clinical development organization succeeds. The role is changing – and with it the necessary leadership profile.

The designation Head of R&D or Chief Scientific Officer is similar, the actual task is not. A global pharmaceutical company is often concerned with portfolio management across multiple indications, complex governance and international resources. A biotech may need a personality that translates scientific entrepreneurial logic into robust clinical development while aligning investors. In medical technology SMEs, product proximity, iterative development, MDR evidence and the connection to production and application are more prominent.

The BVMed describes German medical technology as a strong medium-sized company and puts the industry’s R&D ratio at around nine percent of sales. [5] This underlines their innovation intensity, but does not say anything about which leadership model works in the individual company. A profile from the large corporation is not automatically transferable to a family-run house – and vice versa.

1. Which development phase and which risk profile will shape the next 24 to 36 months?
2. How is decision-making power distributed between science, management, board and investors?
3. Which competencies are strong internally – and which ones need to be built up or supplemented externally?
4. Which regulatory, clinical and industrial interfaces are critical to success?
5. What kind of work does company size actually require?

The search must therefore start from the concrete context. Industry knowledge is relevant; Even more important is the transferability of the completed task.

Hannes Sommer starts an R&D mandate with a profile workshop. Together with management, board, investors and relevant interfaces, it clarifies which decisions should actually play the role: focus a pipeline, build a clinical organization, develop a product under MDR, manage partnerships or prepare the transition to scale.

Only then does the search profile emerge. Scientific reputation and publications can be an important signal, but do not replace the examination of concrete leadership situations. The discussion is about how candidates have prioritized programs, evaluated conflicting evidence, led teams through setbacks, and represented decisions to boards or investors.

Hannes leads a maximum of three mandates in parallel and personally takes over address, qualification and calibration. In this way, the professional and cultural evaluation remains consistent – even if new market insights require an adjustment of the original profile.

A precise search begins with a common view of order and framework conditions. Before approaching the market, companies should answer these questions:

1. What two or three portfolio decisions does the new leadership have to make in the first twelve months?
2. Which scientific competencies are indispensable – and which can be supplemented in the team?
3. Where are the biggest frictional losses between research, development, regulatory, production and commercial today?
4. Which governance and budget are actually available for the role?
5. Which phase of the company must the person have already successfully mastered?
6. After one year, how does it become apparent that the R&D organization makes better decisions and not just generates more activity?

The clearer these answers are, the better the market can be evaluated. A precise mandate does not appeal to fewer people – it reaches the right ones.

Research and development in the healthcare market requires leadership that combines scientific openness and entrepreneurial consistency. The right personality creates transparency over uncertainty, prioritizes resources, integrates regulatory and operational perspectives, and guides teams through successes and setbacks. Executive Search then becomes the lever for an innovation organization that not only produces good ideas, but also makes a robust impact out of them.