In our Clinical Biomarkers & Technology team we have an exciting opening for an Associate Director, Clinical Assay Strategy for in-situ tissue biomarker technologies.In your role as subject matter expert, you will drive the clinical biomarker assay strategy, its implementation in the areas of oncology & immunology and provide advice and guidance for biomarker analysis, data interpretation and decision making in clinical programs.You’ll work in an highly inter-disciplinary development team as well as with commercial technology & solution providers and academic experts to support phase I to post-launch biomarker needs.A key part of your role is to drive the development of clinical biomarker assay strategies employing single- and multiplex IHC/IF/(F)ISH techniques as well as assess and advance the implementation of innovative tissue-based technologies.You’re responsible for ensuring the highest standards in terms of quality and timelines as well as for the execution of Vendor Management & Oversight of external service partners in line with regulatory guidelines.This role is based in Darmstadt, Germany, but can potentially be operated from other locations in Germany. Who you are:A passionate scientist holding a PhD in oncology, immunology, biology, biochemistry, or related fields with 10+ years of experience in the pharmaceutical/biotech industryDemonstrate profound scientific expertise and hands on experience in histology/pathology employing tissue-based/in situ technologiesPassionate about establishing new assays to identify, characterize and monitor biomarkers in tissueProficient in the selection, planning, execution, and reporting of appropriate (non‑)clinical assay development, qualification and validation studiesLong lasting working experience in a regulated environment including GXPs and other applicable regulation and standards.Proficient in spoken and written EnglishHighly motivated, flexible, creative and well-organized individual with excellent communication and interpersonal skills
Standort
Merck KGaA, Darmstadt, Germany, Darmstadt