About this opportunity
Imperatrix Datum Solutions Corporation lists this Associate Medical Director, Imaging opportunity in scottsdale, Arizona. Review the employer’s description below for duties, qualifications and application requirements.
Job description
SUMMARY
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.
Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.
The Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging is primarily responsible for managing the development of essential documents and processes related to image analysis, reader training and reader performance for clinical trials. The Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging may interact with external clients, internal team members, Key Opinion Leaders (KOLs), and Physician Consultant/Contracted reviewers regarding the development of required clinical trial documents. The Associate Medical Director/ Medical Director/ Senior Medical Director, Imaging will be expected to support delivery of IE’s central reader training with regards to study procedures and protocol criteria; and ensuring adherence to Protocol requirements and quality management practices, as applicable.
ASSOCIATE MEDICAL DIRECTOR, IMAGING
RESPONSIBILITIES
Perform and/or assist 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 and Image QC Guidelines
Trial Configuration Specification
Reader Rules and Medical QC Guidelines
Review and/or write medical and scientific training materials and training modules
Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
Review development of reader performance metrics plans and review reader performance data
Design, review, and approve study-related reports (i.e. interim or final reports)
Provide 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
Develop educational and training material for the development internal IE staff, to include, but not limited to various response criteria
Provide educational training for all of IE staff, as required
Collaborate with internal project teams to support sponsor specified project scope of work as required
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 preferred
Minimum of 3 years of experience in medical imaging/or
Minimum of 3 years of experience in clinical research or pharmaceutical industry/or
Preferably 3 years within an imaging core lab (an imaging CRO) with oncology experience
MEDICAL DIRECTOR, IMAGING
RESPONSIBILITIES
Train new hires for associate medical director and/or medical director.
Support business development activities as needed
Oversee, performs and/or assist 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 and Image QC Guidelines
Trial Configuration Specification
Reader Rules and Medical QC Guidelines
Review and/or write medical and scientific training materials and training modules
Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
Review development of reader performance metrics plans and review reader performance data
Design, review, and approve study-related (i.e. interim or final reports)
Provide 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
Develop educational and training material for the development internal IE staff, to include, but not limited to various response criteria
Provide educational training to all IE staff, as required
Collaborate with internal project teams to support sponsor specified project scope of work as required
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 preferred
Minimum of 3 years of experience in medical imaging/or
Minimum of 3 years of experience in clinical research or pharmaceutical industry/or
Preferably 3 years within an imaging core lab (an imaging CRO) with oncology experience
SENIOR MEDICAL DIRECTOR, IMAGING
RESPONSIBILITIES
Support scientific and medical thought leadership and strategic growth
Oversee the training of all medical directors
Support business development activities, as needed
Oversee, performs and/or assist 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 and Image QC Guidelines
Trial Configuration Specification
Reader Rules and Medical QC Guidelines
Review and/or write medical and scientific training materials and training modules
Perform training for internal IE staff, blinded independent central review (BICR) readers, and site radiologists
Review Radiology and Medical BICR data to ensure central reader competence and adherence to study requirements
Review development of reader performance metrics plans and review reader performance data
Design, review, and approve study-related reports (i.e. interim or final reports)
Provide 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
Develop educational and training material for the development of internal IE staff to include, but not limited to various response criteria
Provide educational trainings to all IE staff, as required
Collaborate with internal project teams to support sponsor specified project scope of work as required
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 preferred
Minimum of 7 years of experience in medical imaging/or
Minimum of 7 years of experience in clinical research or pharmaceutical industry/or
Preferably 7 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
Ability to work in strict compliance with 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-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-oriented, fast paced 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
IMAGING ENDPOINTS’ TEAM CHARACTERISTICS
Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
Commitment and caring for our fellow team members, their families, and the communities IE serves – see Caring Endpoints
Integrity and high ethical standards; we always do the right thing
High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE
Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else
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: 10-20% travel (Domestic and International)
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Worksite address
scottsdale, AZ, 85261, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.