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-scienceExperience in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment. Clinical trials imaging operations experience. Preferred RequirementsYou 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