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Director, Clinical Operations

Company: Regional Recreation Corporation of Wood Buffalo
Location: Cambridge
Posted on: April 10, 2021

Job Description:

Career Opportunities - Jounce Therapeutics - Director, Clinical Operations in Cambridge, Massachusetts - Careers at Jounce Therapeutics Skip Branding

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                    • Beyond T Cell -- Jounce Therapeutics, Inc. All rights reserved. - Privacy Policy - Terms of Use Career Opportunities - Jounce Therapeutics - Director, Clinical Operations in Cambridge, Massachusetts - Careers at Jounce Therapeutics Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a job. Welcome page Returning Candidate? Log back in! Director, Clinical Operations Job ID 2021-1241 Category Clinical Operations Job Location US-MA-Cambridge Role / Responsibilities As a key member of the Clinical Operations team, this successful candidate will work closely with the Vice President of Global Development Operations and will be responsible for leading the activities in the preparation, implementation, and completion of various clinical trials in accordance with the program strategy.

                      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. Qualifications
                      • Contribute to the program strategy and development plan
                      • Develop operational scenarios in collaboration with the Medical Lead
                      • Provide clear and concise presentations to senior leaders
                      • Develop and drive study timelines and study plans with the Lead Clinical Trial Managers
                      • 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, as an escalation, 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 develop solutions Provide guidance on the r eview and prepare various clinical study documents including but not limited to model informed consent forms, study protocol and amendments, and Investigator Brochure.
                      • Ensure the maintainence quality and completeness of study master files across programs in compliance with GCP
                      • Represent Clinical Operations in cross-functional initiatives - work closely with program team, discovery, translational and pre-clinical research colleagues.
                      • Manage other Clinical Operations staff Qualifications:
                        • BA/BS; Life Science degree a plus
                        • Work experience to include a minimum of 10 years' industry clinical trial experience (at least 2 years as a Director) with a solid understanding of functional area responsibilities associated with the clinical development process
                        • Minimum 5 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 Statement Equal Opportunity Employer: 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. Company Summary 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. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce's most advanced product candidate,--vopratelimab, is a monoclonal antibody that binds to and activates--ICOS, and--is currently being studied in the SELECT Phase 2 trial. JTX-4014 is a PD-1 inhibitor intended for combination use in the SELECT trial and with Jounce's broader pipeline. Jounce's next development stage product candidate, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state. A Phase 1 trial evaluating JTX-8064 is planned to begin enrollment in the fourth quarter of 2020. Additionally, Jounce exclusively licensed worldwide rights to JTX-1811, a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please Options Apply for this job online Apply Share Email this job to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading... Application FAQs

Keywords: Regional Recreation Corporation of Wood Buffalo, Cambridge , Director, Clinical Operations, Healthcare , Cambridge, Massachusetts

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