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Senior Director, Medical & Scientific Affairs

Scottsdale, AZ, USA | Imaging Endpoint

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Biotech/R&D/Science
  • Experience:
    12-15 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 Senior Director, Medical and Scientific Affairs is responsible for overseeing the Medical and Scientific Affairs Department at IE including medical writing and other clinical trial documents, reader management, and analysis development. The Senior Director, Medical and Scientific Affairs shall ensure that readers are provided adequate training and guidance on study procedures and criteria protocol. The Senior Director, Medical and Scientific Affairs shall oversee and facilitate the inter-departmental communication and coordination between Scientific Affairs and Data Management, Operations and Compliance / Regulatory Affairs while overseeing IE’s Radiologists and other medical/scientific specialists to ensure that sponsor projects are implemented and conducted in accordance with sponsor requirements while ensuring adherence to IE’s quality management system (QMS).


RESPONSIBILITIES


• Oversee 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:


• Study Protocols


• Image Review Charters


• Image Manuals


• Clinical Case Report Forms


• Assessment criteria guidelines


• Analysis configuration specifications


• Reader Rules


• QC of images in collaboration with Operations


• QC of read results in collaboration with DM


• Image analysis reports


• Imaging component of regulatory submissions


• Liaise with Analysis system vendor(s) in understanding system configuration and criteria implementation


• Oversee the provision of training to Radiologists, Oncologists and other Sub-Specialty Physicians on:


• Project-specific Image Review Charter, Image Manual, Reader Rules


• Image analysis platform


• Protocol-specific assessment criteria


• Monitor/evaluate reader results to ensure compliance with protocol criteria and CRF completion requirements


• Oversee development of image QC rules and training based on requirements in sponsor projects


• Oversee development of export specifications based on analysis system/methods used in sponsor projects


• Oversee development of DM QC rules and training based on analysis system/methods used in sponsor projects


• Oversee and provide line-management to Medical and Scientific Affairs staff


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


• Assist in proposal development and business development activities as required


• Interact with and build relationships with Readers, Analysis System Vendors and Sponsors


• Perform other duties as assigned by the supervisors


EDUCATION AND EXPERIENCE


• Bachelor’s degree in healthcare or equivalent work experience


• Minimum of 12 years of experience in clinical research


• Minimum of 7 years of experience in the pharmaceutical or medical device industry


• Minimum of 7 years of experience in medical imaging


SKILLS


• Provide staff with appropriate coaching, mentoring and development


• Hands-on ability to think tactically and strategically


• Proficiency in MS Office and internet applications


• Service oriented approach, flexible and proactive towards adapting to clients’ needs


• Ability to manage project activities with diverse groups and individuals


• 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 also a critical skill


• Work precisely according to all procedures, rules and regulations


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


• Self-motivated and able to grasp new concepts quickly


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


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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