Executive Search for Pharma & Biotech

The path of an active substance from the biological target molecule to market approval follows a fixed sequence, which is both a driver and a risk grid for boards, management and investors. In the pre-clinic, the mechanism of action, toxicity and formulation are tested before a human clinical trial can be requested. The clinical development itself is usually divided into three phases: Phase I clarifies safety and dose determination in a small, usually healthy group, Phase II tests efficacy and side effects in selected patients, Phase III confirms efficacy and safety in large cohorts, often comprising several thousand people, and provides the central evidence basis for approval. After approval, phase IV is followed by controlled observation in everyday care and pharmacovigilance.

Clinical trials are, according to the EU definition, studies intended to demonstrate the efficacy of one or more investigational medicinal products in humans [1]. From a leadership perspective, it is critical that each of these stages demands a different organization: preclinical and early clinic are science-driven and strongly focused on chief scientific officer and chief medical officer, phase III and preparation for approval require significantly enhanced regulatory, clinical operations and CMC leadership, and the transition from research to commercialization – often referred to as “launch readiness” – takes market access, medical affairs, commercial and supply chain equally to the top level.

In pharmaceuticals and biotech, regulation is not a control framework alongside business, but an integral part of value creation. Since the mandatory transition to the European Clinical Trials Regulation and the central information system CTIS, every clinical trial in the EU is requested, evaluated and published via a single portal. The Regulation harmonises assessment, deadlines and transparency to the public and replaces the former national fragmentation [2]. For sponsors involving several Member States, this changes operational planning: timetable, documentation and communication become more predictable, but errors in the preparation of applications are immediately visible.

On the manufacturing side, Good Manufacturing Practice is the mandatory quality system for medicines throughout the EU/EEA and is monitored by inspections by the national competent authorities [3]. GMP is therefore not a downstream plant but a leading issue: location strategy, CDMO selection, technology transfer and capacity planning make a decision about time-to-market and the ability to deliver at peak demand. Where Chief Development Officer, Head of CMC and Head of Quality do not sit at the same table as equal voices, the friction arises that clinical milestones later cost.

European pharmaceutical and biotech companies operate in a politically and financially active environment. In 2025, the European Commission unveiled a life sciences strategy aimed at integrating research, production and market access and positioning Europe as a globally competitive location [4]. In parallel, the Commission and the European Investment Bank have announced the BioTechEU initiative, which aims to mobilise up to ten billion euros for the European biotech sector – a signal that capital is being addressed primarily for scalable platforms and late clinical stages [5].

For management, this means that investors, strategic partners and authorities ask the same questions: Is the pipeline prioritized, is the production strategy resilient, is the commercial setup after approval realistic? In this environment, leadership consists less in selling vision than in robust expectation management to board, investors, partners and their own teams – especially when timetables or endpoints have to be postponed.

What a company really needs in terms of leadership depends less on the balance sheet total than on the maturity phase of its portfolio. In the discovery and early development phases, scientific depth, focus and the ability to rigorously select programs dominate; CSO and CMO personalities with reliable publication history and experience in regulatory scientific advice.

In the late clinical phase, weight is shifting towards Chief Development Officer, VP Regulatory Affairs, Head of Clinical Operations and Head of CMC – complemented by initial leadership for Market Access and Medical Affairs to build benefit assessment, pricing strategy and evidence generation in parallel with the study. With approval and launch, the focus shifts again: Chief Commercial Officer, General Manager for Key Markets, Head of Market Access and a robust supply chain leadership decide whether clinical efficacy is actually translated into care and revenue. In the growth and portfolio phase, Chief Business Officer and Head of Business Development & Licensing will join as pipeline expansion, partnering and life-cycle management become independent delivery drivers.

A serious search in pharma and biotech goes well beyond the examination of the CV. The aim was to demonstrably clarify in which indications and modalities – small molecules, biologics, cell or gene therapies, mRNA platforms – a candidate was actually program-responsible, which study phases were personally conducted and which interactions with EMA, FDA or national authorities are documented.

Experience with application and evaluation processes under CTIS, with GMP inspections and with technology transfers between internal location and CDMO can also be examined. In addition, the fit to the culture and the capital structure is crucial: Anyone who has only led in large corporations with a full resource base must consciously want to change to a well-financed, but resource-scarce scale-up. Finally, structured references with former supervisors, peers and report recipients as well as – where appropriate – certified aptitude diagnostics are part of a process that allows reliable statements on leadership, decision-making under uncertainty and dealing with setbacks.

It is worthwhile for Supervisory Boards, Advisory Boards and Management Boards to consistently align appointment decisions with their own roadmap: Which milestones – study start, read-out, application for admission, launch, capital round – are pending in the next 12 to 24 months, which roles are really critical for this, and where are unfilled or understaffed responsibilities? Roles should not be copied on the basis of past organizational charts, but should be derived from the specific target image.

Equally important is the separation of search and evaluation. A specialized executive search consultant is ideally a roll cutting and market access sparring partner, not a pool seller. Confidentiality towards current incumbents, clean reporting to the selection committee and active support for onboarding are part of a process that protects value creation rather than promises. Hannes Sommer works in this context exclusively mandate-based, personally led and without passing on to junior teams; the connectivity to existing organizations and investor structures is considered from the outset.

Leadership in pharmaceuticals and biotech determines whether scientific hypotheses become approved, supply-relevant products. Those who fill C-level or key positions simultaneously work on eligibility, production reliability and capital strength – within a framework that visibly shapes EMA, Clinical Trials Regulation, GMP and current European investment and strategy initiatives. A search process that takes these dimensions seriously and derives roles from its own roadmap significantly reduces the risk of expensive misoccupations – and makes leadership a were driver that is actually reflected in study, approval and market figures.