Shire ESA Operations – Investigator Initiated Research Manager in Lexington, Massachusetts
• Oversee Investigator Initiated Research (IIR) programs within assigned Therapeutic Area(s)
• Manage the IIR proposal review process for assigned Therapeutic Area(s)
• Support the initiation and conduct of IIR(s) through internal and external stakeholder coordination.
• Monitor and report progress and outcomes of IIRs to internal stakeholders
Manage all aspects of the IIR review and approval process from proposal review all the way through study completion:
Coordinate with the IIR committee chair and IIR group lead for the timely review of IIR proposals by the global grant review committee and additional internal stakeholders.
Facilitate global IIR review committee meetings
Ensure appropriate and efficient follow-up of review committee action items, decisions, and/or requests for additional information regarding IIR proposals
Work with legal, regulatory and compliance colleagues to facilitate the efficient creation and execution of IIR study contracts and amendments
Secure and manage IIR drug supplies and vendors, forecast study drug supply requirements, and initiate requests for assigned programs
Interact directly with external Principal Investigators, research sites, and/or CROs to ensure compliance with Shire IIR policy, global and local healthcare laws
Tracks study progress against proposed timelines and provides regular updates to key internal stakeholders (e.g., Evidence Generation Lead) on IIR study progress
Collect and evaluate IIR study progress reports for adherence to compliance guidelines
Secure study results, required documentation, and publications from completed studies and coordinate with appropriate functional groups for review and implement study closure procedures
Oversee Investigator initiated research (IIR) programs within assigned Therapeutic Area(s):
Develop annual IIR plan in collaboration with key internal stakeholders
Support the development of areas of interest for IIRs
Engage and communicate clearly and concisely with external and internal stakeholders, globally, regarding all aspects of the IIR program.
Work with appropriate study team members to ensure compliance with Shire IIR processes, systems, and regulations, external healthcare laws
Stay informed of applicable governmental compliance laws and industry standards for IIRs
Monitor and report progress and outcomes of IIRs to internal stakeholders:
Provide regular updates to Evidence Generation Lead and other internal stakeholders regarding IIR-related activities
Communicate IIR study progress to key stakeholders to facilitate ongoing functional and regional planning and inform dependencies
Follow up with principal investigator to determine results of research and planned publications
Report outcomes of IIR to internal stakeholders
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.