• IND Operations Manager

    Job ID
    12352
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Clinical Research Support Services
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The IND Operations Manager will be responsible for overseeing a team that manages the FDA-directed IND Sponsor responsibilities associated with Institution-Sponsored Investigational New Drug (IND) program. This position and program reside in the Fred Hutch/University of Washington central clinical trails office, Clinical Research Support (CRS). The position will manage numerous studies (projects) from early concept through study start-up, provide guidance to investigators, study teams, and industry partners, and manage related FDA interactions and communications. In addition, this position will work with Regulatory Affairs to define and implement best practice for IND management across the Cancer Consortium institutions: Fred Hutchinson Cancer Research Center, Seattle Children’s, the University of Washington, and the Seattle Cancer Care Alliance. The position will report directly to the Assistant Director, Clinical Research Regulatory Affairs and Compliance in Clinical Research Support (CRS).

    Responsibilities

    • Define best practices for investigator-initiated IND management; create and maintain Standard Operating Procedures (SOPs) and ensure compliance with the SOPs.
    • Collaborate with Consortium faculty and research teams to provide integrated IND regulatory support for planned projects
    • Ensure Sponsor oversight and reporting requirements are met.
    • Oversee and manage study Data and Safety Monitoring Boards (DSMBs).
    • Manage operations and workload of regulatory project team, plan resource needs, and strategize growth.
    • Manage and coordinate related FDA interactions, including conference calls, meetings, and written responses.
    • Assist with the development of standard training requirements and ongoing regulatory-related education and training for investigators and Consortium research personnel.
    • Oversee Sponsor regulatory files including IND, Investigator, Manufacturing, and Trial Master Files.
    • Represent CRS as a regulatory consultant at process improvement workgroups, institutional meetings, and conferences.
    • Identify Consortium and program improvement opportunities and lead improvement efforts within team, including technology solutions.
    • Coordinate with Regulatory Affairs team as needed to address compliance matters.
    • Liaise with investigators, study teams, industry partners, and Institutional Review Office (IRO) representatives on all Institution-Sponsored IND projects.

    Qualifications

    • Bachelor’s degree (Master’s degree preferred).
    • Minimum of 5 years of regulatory IND experience in the conduct of interventional, treatment, and/or FDA-regulated clinical trials, preferably oncology trials.
    • Experience as a lead or senior research or regulatory coordinator with supervisory experience. Project management experience a plus.
    • Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
    • Clinical research-related certification (may be obtained within the first year of employment).
    • Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
    • Excellent interpersonal skills with the ability to build strong relationships across multiple organizations and to remain calm, professional, diplomatic, and positive.
    • Advanced knowledge of MS Word and Acrobat

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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