Senior Director (m/f/d) - Digital & AI R&D Transformation

The Senior Director, Digital & AI R&D Transformation shapes Fresenius Kabi’s future Digital & AI agenda for Research & Development.

With senior R&D, Medical, Clinical, Regulatory, Quality and Business Unit leaders, the role defines the digital vision for discovering, developing and sustaining products beyond 2030, enabling increasingly AI-first, data-driven, connected and digitally enabled R&D.

As R&D leadership’s strategic Digital & AI partner, the role owns the R&D Digital & AI Trend Radar, continuously assessing emerging technologies, scientific advances, industry developments and disruptive innovations over a 3-5 year horizon. It translates trends into actionable recommendations on organizational implications and opportunities to improve speed, quality, evidence generation and portfolio value.

The role provides end-to-end Digital & AI portfolio transparency across R&D, serving as the primary reference for ongoing, planned and emerging initiatives. It identifies, prioritizes and sequences opportunities across discovery, formulation and product development, clinical development, regulatory affairs, medical evidence and R&D knowledge management, guiding investment and recommendations to continue, scale, evolve or stop initiatives.

Through an agile team of AI & Digital Innovation Acceleration Managers and Business Unit partners, the role translates R&D challenges and ambitions into Digital & AI use cases, guiding strategic advisory, opportunity identification and proof-of-value pilots, with recommendations and decision support for investment and scaling.

With the Digital & AI Capability and Workforce Strategy & Engagement teams, the role strengthens digital capabilities, adoption and workforce transformation for AI-enabled R&D. As an external ambassador, it represents Fresenius Kabi’s Digital & AI perspective in relevant life-science forums, innovation networks and strategic partnerships, aligned with Group and segment stakeholders.

Main Responsibilities:

Shape the Future of R&D

• Define the Digital & AI vision for R&D across the end-to-end product development lifecycle.

• Continuously assess external market trends, emerging technologies, scientific advances and leading practices in life sciences R&D.

• Identify future capability requirements needed to improve development speed, scientific quality, regulatory readiness and portfolio competitiveness over the next 3-5 years.

• Develop strategic roadmaps that balance long-term ambition with practical execution in a regulated and heterogeneous R&D environment.

Trend Monitoring & Innovation Scouting

• Establish a systematic process to identify and assess emerging technologies through an R&D Trend Radar, and regularly communicate findings across R&D and Digital governance bodies.

• Build partnerships with technology providers, start-ups, academic institutions, research networks and relevant industry consortia.

• Assess each trend against maturity, scientific and business relevance, GxP and regulatory implications, responsible AI requirements, cross-Business-Unit scalability and value, with a clear recommendation to act, pilot, monitor or discontinue.

Digital Portfolio Ownership & Synergy Realization

• Own the portfolio view of Digital & AI initiatives across R&D and maintain transparency of the digital maturity landscape across functions and Business Units as the foundation for scaling decisions.

• Identify duplication, capability gaps and synergies; recommend consolidation, reuse or scaling opportunities; and prioritize investments based on strategic importance, scientific impact, business value and feasibility.

• Connect related initiatives across R&D, Quality, TechOps, Commercial, Data & Analytics and Kabi IT to strengthen reuse and end-to-end value.

Big Bets, Use Cases & Proof of Value

• Identify high-value AI and digital opportunities across scientific knowledge discovery, formulation and process development, clinical development, evidence generation, regulatory authoring and intelligence, and R&D operations.

• Shape high-impact use cases together with Business Unit Digital Partners and R&D leaders, including value cases, success criteria, data requirements, responsible AI considerations and committed business sponsors.

• Functionally lead an agile delivery team during the Proof of Value phase, own the go/no-go decision gate following completion and ensure a scalable transition into R&D functions and Kabi IT.

• Steer value realization throughout broader deployment and support lighthouse use cases that make the future-state R&D vision tangible.

Lead Business Transformation

• Serve as a trusted advisor and single point of entry into Digital & AI for senior R&D stakeholders across Business Units and global functions; facilitate cross-Business-Unit strategic dialogue and support executive decision preparation.

• Ensure global solutions are designed for reuse, interoperability and scalability across product areas, regions and Business Units.

• Align R&D, Digital & AI and technology stakeholders around common objectives. Act as the key interface to Kabi IT, Fresenius Digital Technology, Data & Analytics, Quality, Regulatory Affairs and Medical Affairs; lead through expertise and relationships while proactively identifying strategic risks and escalating significant deviations.

• Champion fit-for-purpose data foundations, knowledge management and responsible AI practices that enable trusted reuse of scientific and development data.

• Leverage Enablement and Transformation resources within the team to strengthen digital capabilities, drive adoption and support the workforce transformation required for AI-enabled R&D.

Requisite Qualification & Experience:

• At least 10 years’ relevant experience in R&D, product or clinical development, regulatory or medical affairs, or a closely related field, including significant experience in global pharmaceutical, life sciences, medical technology, biotechnology or similarly regulated R&D environments.
• University degree in science, medicine, engineering, technology or business; an advanced scientific degree or MBA is a plus.
• Proven leadership of large-scale digital, data, AI or R&D transformation, including building value cases and securing executive sponsorship for strategic investments.
• Strong knowledge of R&D systems and data landscapes (e.g., PLM, ELN, LIMS, clinical platforms, eTMF, CTMS, regulatory information management and scientific data platforms), modern data and AI architectures, and the technical fluency to challenge assumptions and estimates.
• Hands-on experience in international matrix organizations spanning multiple Business Units and R&D sites, with fragmented processes, systems, data and accountabilities.
• Experience navigating life sciences requirements for GxP, data integrity, privacy, intellectual property, validation and responsible AI.
• Fluent in English, written and spoken; German or further language skills desirable.
• Willingness to travel internationally on a regular basis, with an indicative travel share of 30-40%.