Posted to MedZilla on 6/24/2017


Takeda Pharmaceuticals

US-MA, External Network Manager, Associate Director/Director, Imaging Operations 1700337-MZ


 
 

OBJECTIVES:
  • As an External Network Manager for the Imaging group, manage business operations and have broad responsibility for budgets, contracting, project management and tracking for assigned projects within the Imaging group.
  • Work with TREC Imaging scientists to provide a seamless interface of TREC imaging with preclinical and clinical operations teams for imaging trials and preclinical and clinical studies containing imaging components across TAs.
  • Responsible for developing, implementing, and maintaining information and communications strategies & approaches to promote collaboration and project success within the Imaging group as well as between internal & external stakeholders.
  • Management and oversight of processes and documentation between Imaging and internal & external stakeholders. Manages review of internal documents with an imaging component and of technical documents from external imaging partners.
  • Serves as Takeda s main administrative point of contact for building and maintaining the External Imaging Network (outsourced) for assigned Imaging CROs (both preclinical and clinical); Academic Imaging Centers (both, preclinical and clinical), and Image Archive & Analysis vendors.

ACCOUNTABILITIES:

  • As a subject matter expert in Imaging, actively participate in project operational team meetings to ensure that project priorities and timelines with respect to imaging are being met and to assure TREC imaging relationships are functioning appropriately with regards to studies containing imaging components.
  • In conjunction with Outsourcing, Legal and Clinical Operations, manage and actively provide imaging operational support for CDAs, consultancy agreements with Imaging KOLs and MSAs for imaging CROs and other imaging-related vendors to ensure timely availability of their services
  • Collaborate with imaging CROs and academic center imaging activities to ensure project timelines , resource needs and budgets meet Takeda expectations
  • Work with TREC Imaging scientists to coordinate and facilitate timely incorporation of imaging components into protocol synopses, full protocol and informed consent documents
  • Work closely with CSMs to implement imaging-specific component of research protocols
  • Assist Outsourcing with technically accurate descriptions of requested imaging services /timelines in RFPs generated for imaging CROs
  • Work with regulatory to ensure compliance of imaging biomarker trials
  • Work with CMC to ensure timely material supply of precursors for PET studies
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS/BA degree in biology, allied health, pharmacy or related life science
  • Experience as a nuclear medicine or MRI technologist in a clinical practice setting, or alternatively management and technical experience in an imaging company or CRO performing imaging in clinical trials
  • Experience in drug development processes in the pharmaceutical industry strongly desired
  • Financial operations management strongly desired.
  • Must have strong project management and organizational skills
  • Must have excellent interpersonal skills as well as good negotiation and influencing skills
  • Good analytical and problem-solving skills
  • Strong written and verbal communication skills
  • Powerpoint, Excel, Word and MS Project skills

LICENSES/CERTIFICATIONS:

  • Image Technologist certification (or related field) preferred but not compulsory ( Nuclear Medicine or MRI preferred)
PHYSICAL DEMANDS:
  • Ability to sit and stand for long periods of time
  • Carrying, handling and reaching for objects
  • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
TRAVEL REQUIREMENTS:
  • Willingness to travel to both internal and external meetings, including overnight trips. National and international travel is required.
  • Requires approximately 20% travel

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