Medical Director / Senior Medical Director
Cambridge, MA, USA | Jounce Therapeutics, Inc.
Industry:Pharmaceutical / Biotech
Job Description:79 people have viewed this job
The Medical Director will execute parts of the clinical development strategy for one of Jounce’s Immuno Oncology programs, JTX-8064, an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. He or she will be responsible for the several clinical activities related to the program.
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 JTX-8064.
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
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
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 withPK, stats, clin ops, medical affairs and other teams involved in clinical development oversight
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