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 priorities
• Provide expert imaging operations input from protocol development, vendor selection to execution of the imaging component of the clinical trials
• Drive and lead the successful execution, oversight and approval of imaging trial document plans, imaging read schedules and workflow for assigned trials
• Lead 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 mitigation
• Serve as the point of escalation to clinical trial teams (CTT) and facilitate resolution of issues
• Accountable 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 implemented
• Identify 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 level
• Accountable 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 appropriate
• Contribute 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 documents
• Keep 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 requirements

• BS 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 Requirements

• You have experience in imaging CRO oversight and implementing quality control measures
• You have experience working in multiple therapeutic areas (including in oncology), phase II and/or III clinical trials from start-up to close-out
• You work efficiently in a fast-paced, collaborative, matrixed, multinational work environment
• You do not shy away from challenging the status quo, you bring new ideas forward and striv