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Sr Director, Medical & Scientific Affairs

Company: Imperatrix Datum Solutions Corporation
Location: Scottsdale
Posted on: September 12, 2020

Job Description:

Home » Jobs » Sr Director, Medical & Scientific Affairs

Sr Director, Medical & Scientific Affairs 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 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

9977 N. 90th Street, Suite 300

Scottsdale, AZ 85258

Phone 480.314.3070

Fax 480.314.3080

9977 95th Street, Suite 101

Scottsdale, AZ 85258

Phone 480.314.3070

Fax 480.314.3080

460 Totten Pond Rd, Ste 420

Waltham, MA 02451-1991

Phone 480.314.3070

Fax 480.314.3080

Keywords: Imperatrix Datum Solutions Corporation, Scottsdale , Sr Director, Medical & Scientific Affairs, Other , Scottsdale, Arizona

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