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Vice President, Medical and Scientific Affairs

Imaging Endpoint

This is a Full-time position in Scottsdale, AZ posted October 31, 2021.

This position can be located in Imaging Endpoints’ Waltham, MA or Scottsdale, Arizona Office or remotely

JOB DESCRIPTION

The Vice President, Medical and Scientific Affairs is responsible for overseeing the Medical and Scientific Affairs (SA) Department at IE including medical writing and other clinical trial documents, analysis development and reader management.

The VP, Medical and Scientific Affairs shall oversee and facilitate the inter-departmental communication and coordination between Scientific Affairs and Data Management, Imaging Operations and Compliance / Regulatory Affairs to ensure that sponsor projects are implemented and conducted in accordance with IE’s requirements.

RESPONSIBILITIES

• Oversee and provide line-management to Scientific and Medical Affairs staff; organize and manage rapidly growing workload to meet client deliverables for staff based in several offices globally

• Oversee SA team’s execution of medical/scientific project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines including but not limited to development, review and finalization of:

• Study protocols

• Study specific assessment criteria

• Image Review Charters

• Image Manuals

• Clinical Case Report Forms

• Image analysis system’s trial configuration specifications

• Reader Rules

• Image QC in collaboration with Imaging Operations

• Read QC in collaboration with DM

• Reader performance evaluation

• Image analysis reports

• Oversee the Analysis Systems Group that configures and maintains the image analysis system per study specific trial configuration specifications

• Oversee the Reader Operations Group that provides onboarding, training and management of radiologists, oncologists and other sub-specialty physicians

• Collaborate with other department heads and internal project teams to prioritize deliverables and support project scope of work

• Assist in proposal development and business development activities as required

• Interact with, build relationships with and support physician readers, vendors and sponsors

• Perform other duties as assigned

EDUCATION AND EXPERIENCE

• Bachelor’s degree in healthcare related field; advanced degree preferred

• Minimum of 10 years of experience in clinical research

• Minimum of 7 years of experience working with the pharmaceutical industry and medical imaging

• Minimum of 5 years in management of diverse, global teams

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

SKILLS

• Ability to find and retain top industry talent

• Strong team management skills with ability to structure, organize, coach, mentor, train and develop staff

• Ability to manage project activities with diverse groups and individuals

• Ability to think strategically and tactically and develop plans accordingly

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

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

• 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 to the changing needs of the day to day business is a critical skill

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

• 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

• Work precisely according to all procedures, rules and regulations

• Ability to understand technical research protocols and successfully lead within the research environment

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

• Highly-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