• Director, Clinical Operations

    Job ID
    2018-1132
    Category
    Clinical Operations
    Job Location
    US-MA-Cambridge
  • Company Summary

    Jounce Therapeutics, Inc. is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in a Phase 1/2 trial. For more information, please visit http://jouncetx.com/

    Role / Responsibilities

    As a key member of the Clinical Operations team, this successful candidate will work closely with the Vice President of Clinical Operations and will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the Development Plan.

    This position also provides an opportunity to join a growing development organization and contribute substantially to how the company will operationalize novel immunotherapy oncology trials in the future.  In addition, there is an opportunity to expand your knowledge in the scientific and  research aspects of   immunotherapy in oncology through day-to-day activities and close interactions with the Translational Sciences, Research and Discovery teams within Jounce.

    Responsibilities:

     

    • Develop and drive study timelines and study plans
    • Responsible for vendor oversight (CRO, central lab, specialty vendors, etc.)
    • Responsible for managing approved trial budget(s)
    • Develops and oversees study operational plan(s)
    • Interface with the CRO regarding follow-up of status of project activities and deliverables (including but not limited to site identification and selection, pre-trial activities, enrollment, management/conduct, database lock, post-study activities)
    • Proactively identifies project risks and resolves with some supervision, as needed
    • Review and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
    • Maintain and ensure the quality and completeness of study master files across programs in compliance with GCP
    • Represent Clinical Operations in cross-functional initiatives – work closely with discovery, translational and pre-clinical research colleagues.
    • Manage other Clinical Operations staff

    Qualifications

    Requirements

     

    • BA/BS; Life Science degree a plus
    • Work experience to include a minimum of 10 years’ industry clinical trial experience (at least 5 years as a study lead) with a solid understanding of functional area responsibilities associated with the clinical development process
    • Minimum 2 years of direct supervisory experience
    • Strong working knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
    • Must have strong project management, communication (oral and written), and analytical skills
    • Excellent interpersonal skills, with a demonstrated ability to work in a team environment as well as independently, are required
    • Additional attributes include an ability to multi-task, be flexible, and to thrive in a fast-paced environment
    • Must be able to travel 15%

     

    Please apply at https://careers-jouncetx.icims.com/

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