Imaging Operations Lead

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. 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: As Imaging Operations Lead you will provide leadership and expert input into all imaging operations aspects at the trial, program and/or portfolio level. Our imaging capabilities include all modalities with a focus on CT, MRI and PET in various therapeutic areas including oncology, neurology and immunology. You will work closely with cross-functional leads for assigned trials, internal and external business partners, imaging vendors, Head of Specialty Operations and other Global Development Operations leaders to design and deliver our clinical trials with speed, quality and efficiency as follows:Drive with internal and external business partners, the development of the Operational Clinical Trial Imaging Strategy Plan at trial level across Phase I-IV, that is in line with our strategic imperatives and prioritiesProvide expert imaging operations input from protocol development, vendor selection to execution of the imaging component of the clinical trialsDrive and lead the successful execution, oversight and approval of imaging trial document plans, imaging read schedules and workflow for assigned trialsLead imaging vendor(s) governance meeting and member of the Imaging Center of Excellence, as well as ad hoc engagements to maintain high performance and address immediate issues and risk mitigationServe as the point of escalation to clinical trial teams (CTT) and facilitate resolution of issuesAccountable for the imaging operations performance and quality metrics at trial/program/portfolio level and identify trends, issues, and risks. Work closely with CTT, internal and/or external business partners to ensure mitigation plans are defined and implementedIdentify gaps within the processes (either internal or external), which may impact key deliverables (timelines/ quality/costs) and work closely with internal and/or external business partners to ensure action or mitigation plans are defined and implemented at portfolio levelAccountable for raising awareness of such trends/issues/gaps in imaging processes and facilitate solutions, working closely with relevant internal and/or external partners, ensure CAPA are defined and implemented. Raise awareness of trends/ issues (within and across program) with key internal/external partners, department leader and/or senior management as appropriateContribute to imaging excellence by providing training to CTTs on trial imaging related aspects and lead and/or contribute to related process improvements and standardization of documentsKeep up to date with imaging related innovations, technologies, vendors, regulatory changes and lead or contribute to continuous improvement initiatives Location: Billerica, MA Hybrid.Position can be located in Germany, UK, or Ireland. Who You Are: Minimum requirementsBS degree and 5- 8 years of experience or MS degree with 3-6 years of experience, or PHD 2-5 years of experience in imaging or related life-science Experience in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment.Clinical trials imaging operations experience. Preferred RequirementsYou have at least 10 years experience in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with 5+ years of clinical trials imaging operations experienceYou have experience in imaging CRO oversight and implementing quality control measuresYou have experience working in multiple therapeutic areas (including in oncology), phase II and/or III clinical trials from start-up to close-outYou work efficiently in a fast-paced, collaborative, matrixed, multinational work environmentYou do not shy away from challenging the status quo, you bring new ideas forward and strive to raise the barYou are passionate about making an impact on people’s lives by helping bring more medicines, to more patients, fasterYou have a data driven and end to end mentality and make data driven and risk-based decisionsYou have excellent interpersonal skills, and you influence others without authorityYou build and maintain effective relationships with internal and external partners

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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! If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html