Director, R&D (f/m/d) Autoimmunity

Phadia GmbH; Freiburg im Breisgau; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Company pension scheme

Fringe benefits

Outstanding career development Pros}

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Job summary

Thermo Fisher Scientific Inc. in Freiburg, Germany, seeks a Director of R&D (f/m/d) Autoimmunity to lead advanced diagnostics development, set strategic direction, and drive the end-to-end lifecycle from concept to commercialization.

You will manage scientists and technical experts while ensuring IVDR/FDA/ISO regulatory compliance and collaborating across functions to deliver transformative autoimmune diagnostic solutions. Travel up to 25%.

Qualifications

• Advanced Degree in Immunology, Biochemistry, Molecular Biology, Biomedical Engineering, or related field.
• 10+ years of professional experience in IVD assay development and leadership.

Responsibilities

• Define and execute Autoimmunity R&D strategy and roadmap aligned with priorities.
• Prioritize programs, allocate resources across innovation and lifecycle management.
• Oversee end-to-end assay development from concept to commercialization.
• Ensure regulatory compliance with IVDR, FDA 21 CFR 820, ISO 13485.
• Lead and develop high‑performing R&D teams; foster scientific rigor.
• Collaborate with Product, Marketing, Quality, Regulatory and Medical Affairs.
• Represent R&D in governance forums and manage external collaborations.

Skills

Strategic leadership

People leadership

Cross-functional collaboration

Prioritization and resource allocation

Science-driven decision making

Education

Advanced degree in immunology or related field

Tools

Regulatory knowledge (IVDR, FDA 21 CFR 820)

Quality systems (ISO 13485)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.

Thermo Fisher Scientific’s R&D Autoimmunity department provides end-to-end scientific leadership for our Autoimmunity in vitro diagnostic (IVD) assay portfolio, spanning development, lifecycle management and continuous improvement. Operating within a regulated global environment (IVDR, FDA 21 CFR 820, ISO 13485), the team delivers clinically robust, analytically sound, and commercially sustainable diagnostic solutions.

Director, R&D (f/m/d) Autoimmunity

Discover Impactful Work

As Director of R&D, you’ll lead the team developing advanced autoimmune diagnostics that enable our customers to make the world healthier, cleaner, and safer. You’ll establish strategic direction for Autoimmunity R&D initiatives, own the R&D roadmap, and cultivate a culture of scientific excellence and collaboration. You'll establish strategic direction for R&D initiatives while cultivating a culture of scientific excellence and collaboration. Working closely with cross-functional partners, you'll oversee the full development lifecycle of IVD immunoassay from concept through commercialization, ensuring successful delivery of effective solutions.

You’ll support and develop teams of scientists, laboratory technicians and technical experts while maintaining strong connections across the organization to advance innovation and technological progress. This role offers the opportunity to contribute to scientific discovery through leadership of research programs and development of transformative products.

This role is fully office-based at our Freiburg, Germany site. Some international travel will be required – up to 25% of working time, including overnight stays.

A day in the Life

Strategic & Portfolio Leadership

• Define and execute the Autoimmunity R&D strategy and roadmap aligned with portfolio and innovation priorities
• Prioritize programs and allocate resources across innovation, lifecycle management, and regulatory commitments
• Contribute to lifecycle planning (line extensions, upgrades, cost optimization, portfolio rationalization)

Assay Development Execution

• Lead end-to-end assay development: feasibility, design, risk analysis, verification and validation
• Drive research on biomarkers and disease-relevant targets for potential diagnostic applications, and drive translation of selected opportunities into the closed, fully automated IVD platform

Regulatory & Quality Compliance

• Ensure compliance with IVDR, FDA 21 CFR 820, ISO 13485, and applicable regulations
• Oversee DHF, technical documentation, risk management activities and regulatory submissions (with RA)
• Ensure audit readiness and effective CAPA execution

Sustaining Engineering & Lifecycle Management

• Provide technical oversight of post-market surveillance, and performance monitoring
• Lead investigations into complaints, trends, and field issues; ensure timely root cause analysis and corrective actions
• Address assay variability, stability, raw material changes, and manufacturing deviations
• Support supplier changes, material obsolescence management, and supply continuity

People & Organizational Leadership

• Build and develop high performing R&D teams
• Foster a culture of scientific rigor, accountability, and continuous improvement
• Develop succession pipelines and technical career paths
• Operate effectively within a global, matrixed organization

Cross-Functional & External Collaboration

• Partner with Product Innovation, Marketing, Quality & Regulatory and Medical Affairs to translate clinical, customer, and portfolio needs into product requirements
• Collaborate with Clinical Affairs on validation strategies and studies
• Develop and maintain scientific collaborations with KOLs, clinical networks, academic institutions, and external partners
• Provide R&D governance of external research collaborations, including coordination of appropriate NDAs, CDAs, and MTAs with relevant functions
• Represent R&D in governance forums and executive reviews

Keys to Success

• Advanced Degree in Immunology, Biochemistry, Molecular Biology, Biomedical Engineering, or related field
• 10+ years of professional experience in IVD assay development
• Extensive experience leading and coaching people leaders and individual contributors, building high performing R&D teams and developing organizational capabilities for the future
• Demonstrated ability to establish clear priorities across a complex R&D portfolio, drive prioritization and trade‑off decisions with teams and stakeholders, and allocate resources in line with strategic and business priorities
• Demonstrated success delivering innovative products from concept through commercialization with stage‑gate product development processes, managing complex projects, budgets and resources in a dynamic environment with competing priorities requiring strong prioritization
• Strong scientific expertise relevant to autoimmune disease areas
• Strong understanding of quality systems and regulatory requirements (FDA, ISO, GMP)
• Demonstrated success leading organizational change, including evolving ways of working, strengthening accountability and collaboration, and shaping the culture and mindset required to improve organizational effectiveness
• Effective communication and presentation skills, with the ability to create clarity, alignment and engagement through change
• Demonstrated ability to influence and collaborate across functions, navigating a complex matrix organization
• Strategic mindset paired with business acumen and customer orientation
• Proficiency in English required; German highly preferred

What we offer

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of , color, religion, _ , orientation, gender identity, national origin, disability or any other legally protected status.