Jounce Therapeutics

  • Clinical Scientist

    Job ID
    2018-1169
    Category
    Research & Development
    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 the human tumor microenvironment (TME) to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce has three development stage programs: its two clinical product candidates, JTX-2011, a monoclonal antibody that binds to and activates ICOS, and JTX-4014, a monoclonal antibody that binds to PD-1 to be used in combination with its pipeline of future product candidates, and JTX-8064, a monoclonal antibody that binds to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) that is currently in the IND-enabling phase. For more information, please visit www.jouncetx.com.

    Role / Responsibilities

    Jounce Therapeutics is seeking an experienced Clinical Scientist to contribute to the development of novel therapeutics in the exciting field of cancer immunotherapy. The successful candidate will assist in defining the clinical strategy and creation of the clinical and integrated development plans for multiple oncology indications for Jounce clinical and pre-IND programs as the clinical representative on cross-functional integrated program teams.

     

    Responsibilities:

    • Design innovative and feasible clinical trials in collaboration with biology, translational research, and clinical team members.
    • Author clinical trial documents including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
    • Interact frequently with investigators to share new scientific and clinical data and maintain enthusiasm and engagement to optimize clinical trial enrollment
    • Conduct regular review, analysis, and interpretation of study results
    • Participate in tracking/analysis of any potential safety events within an individual clinical trial and across trials for assigned program(s).
    • Serve as primary point of contact for clinical study inquiries from site staff, CROs and site monitors regarding the study protocol, modifications to informed consent, and scientific or medically related questions.
    • Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan.
    • Present at internal and external meetings (e.g., Portfolio reviews, partner meetings, clinical advisory boards, Board of Director meetings, Investigator meetings, pre-study site selection visits (PSSV) and site initiation visits (SIVs), Study Coordinator and CRA training, Advisory Boards, and internal and external medical/scientific meetings).
    • Maintain awareness and keep program team informed of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory) that may impact the investigational agent Clinical Development Plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
    • Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
    • Participate in development of the long-range strategic plans for the assigned program(s).

    Qualifications

    • Candidates should have an advanced clinical/science degree (e.g., Pharm. D., PhD, MSN, MPH, etc.).
    • 5 or more years of industry/related experience in cancer related research or drug development, with at least 3 in clinical development, preferably in immuno-oncology.
    • Extensive knowledge of clinical research and experience across Phase I – III drug development projects
    • Experience working on cross-functional teams
    • Familiarity with clinical trial design and experience authoring clinical trial protocols (Phase I or II)
    • Experience in the analysis and interpretation of clinical data and assessment of clinical relevance
    • Comprehensive understanding of safety profiles and risks
    • Well-versed in medical aspects of GCP, ICH, FDA, EMEA, and other relevant guidelines
    • Ability to work independently and to organize priorities and deliverables.

    To apply, please visit https://careers-jouncetx.icims.com/.

    Statement

    Jounce Therapeutics is an equal opportunity employer and does not discriminate in it’s employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs.  We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

     

     

    To apply, please visit https://careers-jouncetx.icims.com/.

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