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Medical Director, Imaging and Clinical Trials Expert
1 month ago
Job Summary
We are seeking a highly skilled Medical Director, Imaging to join our team at Imaging Endpoints. As a key member of our clinical trials team, you will be responsible for managing the development of essential documents and processes related to image analysis, reader training, and reader performance for clinical trials in accordance with our requirements.
Responsibilities
- Oversee, 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.
- 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.
- 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.
- 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.
Requirements
- MD/radiology degree required.
- 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.
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.
- 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.