Jounce Therapeutics

  • Medical Director

    Job ID
    2019-1190
    Category
    Clinical Development
    Job Location
    US-MA-Cambridge
  • Role / Responsibilities

    The Medical Director will execute parts of the clinical development strategy for one of Jounce’s Immuno Oncology programs, vopratelimab.  He or she will be responsible for the several clinical activities related to the program.  She or he will actively participate in the clinical subteam for the vopratelimab clinical program studies.

     

    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.
    • Partner with Data Management for case report form (CRF) design, instructions for unique CRFs, and Data Quality Plan.
    • Interact frequently with investigators to share new scientific and clinical data and maintain enthusiasm and engagement to optimize clinical trial enrollment
    • Participate actively as the clinical development expert in study implementation, study oversight and study medical monitoring.  
    • Conduct regular review, analysis, and interpretation of study results.
    • Participate in tracking/analysis of any potential safety events across trials for vopratelimab.
    • 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.
    • Present at internal and external meetings (e.g., portfolio reviews, clinical advisory boards, investigator meetings, pre-study site selection visits and site initiation visits, Study Coordinator and CRA training, and internal and external medical/scientific meetings).
    • Maintain awareness and keep program team informed of internal and external developments 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).
    • Participate as the clinical representative in clinical sub-team meetings

    Qualifications

    • The candidate should have a Medical Degree.  Board certified in internal medicine (or pediatrics) and medical oncology or hematology (or pediatric oncology) would be preferable.
    • Candidate should have at least 2 or more years of industry/related experience in cancer related research, drug development and clinical development, preferably in immuno-oncology.
    • Good knowledge of clinical research and experience across Phase I – III drug development projects.
    • Experience working effectively on cross-functional teams (matrix organization).
    • 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
    • Good knowledge and experience with Good Clinical Practice
    • Strong verbal and written skills

    Preferred Skills:

    • Experience designing, conducting, serving as medical monitor, and analyzing data in Phase 1-2 clinical trials in oncology.
    • Strong Scientific/ Translational experience and expertise with biomarker strategies.
    • Experience interacting with Contract Research Organizations.
    • Prior experience writing and submitting INDs to FDA; experience with pre-IND and EOP1 meetings preferred.
    • Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
    • History of strong relationships with academic investigators
    • Demonstrated functioning well in a diverse organization and cross functional such as with  PK, stats, clin ops, medical affairs and other teams involved in clinical development oversight

    Statement

    Jounce Therapeutics is an equal opportunity employer and does not discriminate in its 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/.

    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 a biomarker-driven approach. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within the human tumor microenvironment to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce is developing two clinical-stage programs as well as advancing and building out its broad and wholly-owned discovery pipeline of immuno-oncology targets, including those expressed on T-regulatory cells, macrophages and stromal cells. Jounce’s lead product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS and is currently being assessed in a Phase 2 clinical trial. JTX-4014 is a PD-1 inhibitor intended for use in combination with future pipeline products, and Jounce has completed enrollment in the JTX-4014 Phase 1 clinical trial. In addition, Jounce has exclusively licensed worldwide rights to JTX-8064, a LILRB2 receptor antagonist, to Celgene. For more information, please visit www.jouncetx.com.

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