Associate Director (all genders) Clinical Assay Strategy Cellular Biomarkers

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United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

In our Clinical Biomarkers & Technology organization within Clinical Measurement Sciences we have an exciting opening for an Associate Director, Clinical Assay Strategy Flow Cytometry, reporting to the head of the Clinical Assay Strategy Team. As an acknowledged and respected subject matter expert for cellular biomarkers, you will contribute to the clinical biomarker strategy and its implementation in the areas of neurology, immunology and (immuno-)oncology providing advice and guidance for cellular biomarker analysis, data interpretation and decision making in translational and clinical programs in a close inter-disciplinary and -functional collaboration.

In this role you’ll drive the development of clinical biomarker assay strategies in the field of cellular biomarkers and assess and advance the implementation of innovative flow cytometry-based technologies across programs overseeing the whole process from sample generation up to data analysis and assessment. You design, develop and integrate applications and methods for implementation in the clinical trials setting (phase I to post-launch) with external partners where you will be required to scope, guide and monitor the qualification and validation of such assays. Providing expert advice in the optimization, troubleshooting and issue resolution of applied methods as well as preparation of project-related documentation (e.g. expert reports, etc.) is considered natural part of the role. You will focus on the analysis and assessment of human samples from clinical trials (across all clinical development phases as well as post-launch and LCM) using multiparameter flow cytometry in line with the defined context-of-use applying highest standards in terms of quality and timeliness.

You will be responsible for Vendor Management and Oversight of external partners and service providers in line with regulatory requirements and guidance.

In addition to this, you’ll maintain and build up new collaborations with academic and commercial technology & solution providers to contribute to strategic and tactical directions for state of the art and innovative flow-cytometry-based biomarker testing.

This role is intended to be based at our headquarters in Darmstadt, Germany, but can potentially be operated from other locations in Germany.

Who you are:

• A passionate scientist holding a PhD in immunology, biology, biochemistry, or related fields with 10+ years of experience in the pharmaceutical/biotech industry

• Having a strong scientific background in immunology, oncology & immuno-oncology

• Demonstrate profound scientific expertise in and hands on experience employing 8+ color flow cytometry

• Passionate about establishing new assays and panels in Flow Cytometry to identify, characterize and monitor cellular biomarkers

• Proficient in the selection, planning, execution, and reporting of appropriate (non-)clinical assay development, qualification and validation studies in Flow Cytometry and associated technologies; respective knowledge or experience in classical immunoassays as well as various omics-technologies is a plus

• Demonstrate long lasting experience in the implementation of Flow Cytometry based assays and applications in clinical trials (phase 1 through post-launch) and the performance monitoring of aforementioned assays during clinical samples testing (in particular at external vendors)

• Having strong experience about Vendor Management & Oversight in the pharmaceutical industry and associated regulatory requirements

• Experience in the processing, analysis, data visualization, interpretation and understanding of multifaceted big data (in particular coming from flow cytometry incl. integration of data from other areas) employing state-of-the-art biostatistics and/or bioinformatics technologies and approaches with respective tools would be advantageous

• Long lasting working experience in a regulated environment including GXPs and other applicable regulations and standards

• Proven leadership as well as coaching skills in matrix organizations, would be an asset

• Lead authorship of peer-reviewed scientific publications would be a plus

• Highly proficient in spoken and written English

• Highly motivated, flexible, creative and well-organized individual with excellent communication and interpersonal skills

• Effective at working in a collaborative and diverse team

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!