• Clinical Research Operations Director, Immunotherapy Integrated Research

    Job ID
    14893
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Executive and Management
  • 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. The mission of Fred Hutch is the elimination of cancer and related diseases as causes of human suffering and death. We believe that immunotherapy, particularly adoptive T cell therapies, are at the forefront of these curative treatments for cancer patients. C

     

    The Immunotherapy Integrated Research Center (IIRC) has mission to increase collaborative research and stimulate transformative cancer discovery.  The IIRC clinical research organization (IIRC-CRO) manages adoptive T cell therapy clinical trials in the Bezos Family Immunotherapy Clinic (BFIC) at the Seattle Cancer Care Alliance. The Clinical Program Operations Director oversees this clinical research team and, in collaboration with the Medical Director, the IIRC clinical program. 

     

    As a Fred Hutch strategic initiative, we value inclusion and a diversity of backgrounds and perspectives to inform our work. We believe in supporting each other through mentorship and providing resources for professional development. Given these values, we strive to make our recruitment and promotion processes fair and transparent. Therefore, we strongly encourage all individuals with an interest in the position to apply.

    Responsibilities

    This position reports to the Medical Director of the Integrated Immunotherapy Research Center - Clinical Research Organization (IIRC-CRO) and the Vice President of the Interdisciplinary Science Administration (ISA). This position oversees a portfolio of over 25 clinical research trials and growing, works independently and in cooperation with internal and external stakeholders to manage operations and maintains professional relationships with study sponsors and regulatory agencies, and directs a leadership team that includes regulatory, data, research support, nursing, and administrative roles. Responsibilities include:


    Programmatic Role

    • Collaborate with the program Medical Director to plan and set clinical program goals
    • Develop year over year programmatic goals within the Interdisciplinary Science Administration (ISA) that support overall growth and development of the IIRC-CRO
    • Operationalize and manage metrics in support of IIRC goals
    • Oversee multiple interdisciplinary forums that support a broad range of collaboration, management of trials, and dissemination of programmatic trends and activities
    • On behalf of the Medical Director, and in conjunction with the Program and Operations Manager, oversees the program portfolio and provides data for planning/goal setting. Works independently to plan for program needs based on trial pipeline


    Managerial and Operational Role

    • Directs the IIRC-CRO leadership team, including regulatory, data, research support, nursing, and administrative roles to align on the goals of the IIRC
    • In conjunction with the IIRC-CRO leadership team, oversee the regulatory, safety, compliance and monitoring of the IIRC-CRO trial portfolio
    • Collaborate with the Business Development and Strategy group in messaging the core functions of the IIRC-CRO and value proposition for potential partners
    • Monitor program resources such as space, equipment and personnel, ensuring that current program resource needs are met, and future program resource needs are anticipated

     

    Cross Collaboration Duties

    • Enhance and bridge collaborations with internal and external stakeholders, including clinical sites of practice, external partners and SCCA partners
    • Collaborate with the IIRC Finance team to oversee team budgets, resource allocation and resource planning to support upcoming projects

    Qualifications

    • Bachelor’s degree required
    • Minimum three years of staff management experience and five years of experience in all phases of clinical trials management; must include experience in the management of investigator initiated clinical trials
    • Working knowledge of the finance of clinical trials, proven ability to partner with a finance team to run a financially stable organization
    • Strong knowledge of clinical operations and current regulations related to FDA, INDs, IDEs and Good Clinical Practice
    • Strong prioritization, communication and clinical interpretive skills
    • Proven ability to develop effective, collaborative relationships at all levels
    • Knowledge of medical terminology and statistics is preferred

    Our Commitment to Diversity

    We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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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