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Medical Director / Senior Medical Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Medical Director / Senior Medical Director Company: Jounce Therapeutics, Inc.

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Medical Director / Senior Medical Director Job ID 2019-1190

Category Clinical Development

Job Location US-MA-Cambridge

Role / Responsibilities The Medical Director will execute partsof the clinical development strategy for one of Jounce’s ImmunoOncology programs, JTX-8064, an anti-Leukocyte ImmunoglobulinLike Receptor B2 (LILRB2) antibody and is the firsttumor-associated macrophage candidate to emerge from Jounce’sTranslational Science Platform. He or she will be responsiblefor the several clinical activities related to the program.

Responsibilities:

Design innovative and feasible clinical trials in collaborationwith biology, translational research, and clinical teammembers.

Author clinical trial documents including but not limited toprotocols, charters, safety monitoring plans, IND reports, processdocuments, meeting presentations, publications, and clinicalsections of regulatory documents such as INDs, briefing books,clinical study reports, investigator brochures, annual reports andupdates, and clinical sections of regulatory submissions to supportproduct 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 scientificand clinical data and maintain enthusiasm and engagement tooptimize clinical trial enrollment

Participate actively as the clinical development expert in studyimplementation, study oversight and study medical monitoring.

Conduct regular review, analysis, and interpretation of studyresults.

Participate in tracking/analysis of any potential safety eventsacross trials for JTX-8064.

Serve as primary point of contact for clinical study inquiriesfrom site staff, CROs and site monitors regarding the studyprotocol, modifications to informed consent, and scientific ormedically related questions.

Present at internal and external meetings (e.g., portfolioreviews, clinical advisory boards, investigator meetings, pre-studysite selection visits and site initiation visits, Study Coordinatorand CRA training, and internal and external medical/scientificmeetings).

Maintain awareness and keep program team informed of internaland external developments that may impact the investigational agentClinical Development Plan, including attendance at major scientificconferences, participation in competitive intelligence activities,and periodic literature review.

Maintain current knowledge of the external environment to ensurescientific innovations are considered and/or incorporated intoclinical trial development strategy.

Participate in development of the long-range strategic plans forthe assigned program(s).

Participate as the clinical representative in clinical sub-teammeetings

Qualifications The candidate should have a Medical Degree. Boardcertified in internal medicine (or pediatrics) and medical oncologyor hematology (or pediatric oncology) would be preferable.

Candidate should have at least 2 or more years ofindustry/related experience in cancer related research, drugdevelopment and clinical development, preferably inimmuno-oncology.

Good knowledge of clinical research and experience across PhaseI – III drug development projects.

Experience working effectively on cross-functional teams (matrixorganization).

Familiarity with clinical trial design and experience authoringclinical trial protocols (Phase I or II)

Experience in the analysis and interpretation of clinical dataand assessment of clinical relevance

Comprehensive understanding of safety profiles and risks

Well-versed in medical aspects of GCP, ICH, FDA, EMEA, and otherrelevant guidelines

Ability to work independently and to organize priorities anddeliverables

Good knowledge and experience with Good Clinical Practice

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 withbiomarker strategies.

Experience interacting with Contract Research Organizations.

Prior experience writing and submitting INDs to FDA; experiencewith pre-IND and EOP1 meetings preferred.

Ability to work in a high paced team environment, meetdeadlines, & prioritize work on multiple projects

History of strong relationships with academic investigators

Demonstrated functioning well in a diverse organization andcross functional such as with PK, stats, clin ops, medical affairsand other teams involved in clinical development oversight

Statement Jounce Therapeutics is an equal opportunity employerand does not discriminate in its employment decisions on the basisof race, color, national origin, age, physical or mentaldisability, marital status, religion, creed, sex, or politicalbeliefs. We offer a competitive salary and benefits package. Allapplicants should be legally entitled to work for any employer inthe U.S.

Jounce Therapeutics, Inc. is a clinical-stage immunotherapycompany dedicated to transforming the treatment of cancer bydeveloping therapies that enable the immune system to attack tumorsand provide long lasting benefits to patients through abiomarker-driven approach. Through the use of its TranslationalScience Platform, Jounce first focuses on specific cell typeswithin the human tumor microenvironment to prioritize targets, andthen identifies related biomarkers designed to match the rightimmunotherapy to the right patient. Jounce currently has fourdevelopment-stage programs, two of which are clinical-stage:vopratelimab, a monoclonal antibody that binds to and activatesICOS, and JTX-4014, a PD-1 inhibitor intended for combination usewith Jounce’s broader pipeline. Vopratelimab is currently beingassessed in a Phase 2 clinical trial, EMERGE, and Jounce plans toinitiate an additional Phase 2 biomarker trial using TIS vopra for patient selection, SELECT, to assess vopratelimab incombination with JTX-4014. Jounce’s IND-enabling preclinicalprograms include JTX-8064, a LILRB2 receptor antagonist andJTX-1811, a monoclonal antibody designed to selectively deplete Tregulatory cells in the tumor microenvironment. For moreinformation, please visit www.jouncetx.com .

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Keywords: Jounce Therapeutics, Inc., Cambridge , Medical Director / Senior Medical Director, Other , Cambridge, Massachusetts

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