Director, R&D (f/m/d) Autoimmunity
Core
Lead the R&D team developing advanced autoimmune in vitro diagnostic (IVD) assays and establish strategic direction for the Autoimmunity portfolio.
Role type
Director, R&D (Strategy & Portfolio Leadership)
Builds
Clinically robust, analytically sound, and commercially sustainable IVD immunoassay solutions for allergy and autoimmune diseases.
Domain
Life Sciences / In Vitro Diagnostics (IVD) / Autoimmunity
Required skills
Strategic portfolio management, end-to-end assay development, regulatory compliance (IVDR, FDA, ISO), team leadership, lifecycle management, cross-functional collaboration, scientific expertise in autoimmunity, change management.
Preferred skills
German language proficiency, experience with biomarker research, KOL network management.
Technologies
IVD platforms, automated blood analysis systems, risk management tools, regulatory submission systems.
Responsibilities
Define and execute Autoimmunity R&D strategy and roadmap; Lead end-to-end assay development from feasibility to validation; Ensure compliance with IVDR, FDA 21 CFR 820, and ISO 13485; Build and develop high-performing R&D teams; Partner with Product Innovation, Marketing, and Clinical Affairs to translate needs into product requirements.
Seniority
Director, strategic leadership with hands-on oversight