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Director of Radiology

Scottsdale, AZ, USA | Imaging Endpoint

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    7-10 years
Job Description:
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This position can be located in Imaging Endpoints’ Waltham, MA or Scottsdale, Arizona Office or remotely


JOB DESCRIPTION


The Director of Radiology will manage the development of essential documents and processes related to image analysis, reader training and reader performance for clinical trials in accordance with IE’s requirements.


RESPONSIBILITIES


• Oversees, performs and/or assists with medical/scientific project deliverables for imaging studies in clinical trials in accordance with the project scope of work and within sponsor required timelines including but not limited to:


• Review Protocols, Imaging Review Charters, Imaging Manuals, Image QC Guidelines, Reader Rules and Read QC Guidelines


• Review trial configuration specifications as it relates to image analysis platforms for specific analysis criteria


• Review training materials, training modules, and perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists.


• Radiology and Medical review of BICR data to ensure central reader competence and adherence to study requirements


• Review development of reader performance metrics plans and review performance data


• Design, review, and approval of study-related interim or final reports


• Provides support to internal IE staff on the QC of images and BICR reads based on expert radiological and criteria skill


• Develop expertise, maintain knowledge and train others in the use of IE’s image analysis platforms as it relates to the performance of BICR reads


• Provide education and training to staff for development of key study documents, processes and response criteria


• Collaborate with internal project teams to support sponsor specified project scope of work


• Assist with projects related to IE’s research and technology development studies as requested


• Perform other duties as assigned


EDUCATION AND EXPERIENCE


• MD / radiology degree required, PhD in medical or health science preferred


• Minimum of 7 years of experience in clinical research and medical imaging


• Minimum of 5 years of experience working with the pharmaceutical industry


• Minimum of 5 years within an imaging core lab (an imaging CRO) with oncology experience


SKILLS


• Expert knowledge of radiologic imaging modalities and assessments related to efficacy endpoints common to clinical trials with emphasis in oncology


• Expert knowledge of FDA Guidance documents related to imaging and knowledge of the regulated environment applicable to an imaging core lab and the pharmaceutical drug development industry


• Ability to understand technical research protocols


• Work precisely according to all procedures, rules, and regulations


• Must have superior attention to detail and excellent oral and written communication skills


• Coaching, mentoring, and development


• Ability to think strategically and tactically and develop plans accordingly


• Hands-on service oriented approach, flexible and proactive towards adapting to clients’ needs


• Ability to manage project activities with diverse groups and individuals


• Ability to excel in a team environment


• Must have the ability to multitask and work under pressure


• Must have strong time management and organizational skills. Prioritizing workload according to the changing needs of the day to day business is critical


• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.


• Self-motivated and able to grasp new concepts quickly


• Proficiency in MS Office and internet applications


PHYSICAL REQUIREMENTS


• While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.


TRAVEL REQUIREMENTS


• 10% – 20% travel (Domestic and International)


Imaging Endpoints is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status


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