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
Senior IC R&D Director (Immunodiagnostics)
Builds
Clinically robust, analytically sound, and commercially sustainable IVD immunoassay solutions
Domain
Life Sciences / In Vitro Diagnostics / Autoimmunity
Required skills
Strategic portfolio leadership, end-to-end assay development, regulatory compliance (IVDR, FDA, ISO), team building and coaching, lifecycle management, cross-functional collaboration, biomarker research, change management
Preferred skills
German language proficiency, experience with automated IVD platforms
Technologies
IVD immunoassay platforms, automated blood analysis 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; Provide technical oversight of post-market surveillance and field issue investigations; Build and develop high-performing R&D teams; Partner with cross-functional teams to translate clinical needs into product requirements
Seniority
Director, strategic leadership with hands-on technical oversight
