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We have an exciting opportunity to join our team as a Program Director.
The NYU Vaccine and Treatment Evaluation Unit (NYU VTEU) provides outstanding leadership, scientific innovation, and operational excellence in conduct of high priority federally supported infectious diseases clinical research. The NYU VTEU is part of a network of National Institute of Allergies and Infectious Diseases (NIAID) sites across the US. The NYU VTEU will work the NIAID VTEU network to perform clinical trials and clinical studies of infectious diseases to identify new approaches (e.g., vaccines, treatments, diagnostics, biologics, devices, biomarkers) to protect and restore health.
The primary mission of the NYU VTEU is to contribute to national preparedness for emerging public health threats through rapid responsiveness and surge capacity. The Program Director of the NYU VTEU will manage and oversee planning, implementation, daily administrative, and financial operations for all aspects of the NYU VTEU.
The Program Director will be responsible for primary coordination and management of the VTEU under the supervision of the Principal Investigator (PI), and will act as a liaison with internal (i.e., Office of Science and Research (OSR), Departments of Medicine, Pediatrics) and external VTEU partners (i.e., NIAID-NIH VTEU Network, industry, FDA). This position will report to the Principal Investigator of the NYU VTEU.
- Oversee operations at the NYU VTEU and successful implementation of high profile clinical and translational research including large phase 2-3 COVID-19 vaccine trials. Develop and oversee the development of all Standard Operation Procedures (SOPs) for NYU VTEU. Track the planning efforts of the NYU VTEU and ensure all tasks are completed on time and start-up goals are met. Oversee hiring efforts for the NYU VTEU. Assist the NYU VTEU faculty leadership with the overall strategic planning of the NYU VTEU.
- Oversee conduct of clinical trials and clinical studies at the NYU VTEU and provide guidance in the management of their operations. Supervise all administrative staff members, indirectly supervise the work of research managers in regulatory, community education and recruiting, study clinicians and coordinators, data management and quality management, clinical laboratory and research laboratory. Prioritize resources across teams to ensure NYU VTEU operational strategic goals and milestones are achieved. Identify operational issues within the NYU VTEU and develop sound strategic solutions. Conduct and oversee interactions with OSR and all internal partners, and support the PI and faculty leadership with external VTEU partners. Assist PIs with regular reports to provide the NIAID-NIH VTEU Network, and other stakeholders with routine updates regarding the status of the program through written reports, scheduled meetings, and/or teleconferences, etc.
- Collaborate on establishing standards and appropriate quality control procedures for the NYU-VTEU implement and oversee compliance with these standards and procedures. Ensure key trial materials (e.g. Protocol, Data Management Plans, SOPs, eCRFs, CRF Completion Guidelines, Working Practices, and Training Materials etc.) are updated when necessary through team contributors providing input directly when needed. Coordinate and participate in the implementation of data-driven risk-based monitoring activities to ensure overall data quality, integrity, rigor, and reproducibility standards. Advise the PIs in allocating resources for NIAID-VTEU Network supported clinical trials and clinical studies.
- Lead communications for NYU-VTEU. Lead NYU-VTEU Operations conference calls. Interface with all NYU-VTEU committees and provide reports and status updates to committees as needed. Provide assistance to the PIs in submitting all yearly NIH non-competitive renewal documentation. Oversee NYU-VTEU website development and maintenance. Ensure regular communication with NYU-VTEU administrative staff, NYU-VTEU Research Managers, Department Administrator, and the Office of Science and Research (OSR).
- Oversee financial management of NYU-VTEU budget. Work with the Principal Investigators, Department Administrator, Financial Manager, and NYU Langone Vaccine Center Manager, Administration and Finance, to ensure all the project activities are managed appropriately and to ensure timely and accurate reporting. Review and approve all purchasing and payable requests for payments; research and report any disparities reported on general ledger to ensure accurate budget, budget period, project period, facilities and administration rate, recording of expenditure and income information; prepare financial analyses, forecasts, projections, plans, and profit and loss statements for the project. Oversee all aspects post-award fiscal and administrative management of project including progress reports to NIAID-NIH; subcontractor monitoring; staff salary allocations, and requests for carryover, no cost extensions and reductions in effort. Ensure spending on awards is appropriate, within budget and allowable per funding entity guidelines. Submit re-budgets as appropriate. Review and analyze all assigned monthly financial statements and monitor the ongoing activities in order to verify their accuracy and compliance with NYULH policies and procedures; develop overall budget projection analysis for review with PI; track actual project spending against planned project spending.
- Conduct other activities in direct support of NYU-VTEU. Manage NYU-VTEU Financial and Administrative Managers and other support. Update and maintain internal tracking systems to ensure all project milestones and deliverables are on time. Fulfill other duties as assigned.
To qualify you must have a Masters level with a minimum of 10 years of experience in academic research setting, pharmaceutical and/or Clinical Research Organization (CRO) setting conducting IND/IDE clinical trials and human subjects research with at least five years of management experience.
This position requires a self-starter with a solid foundation in ICH/GCP regulations. Experience in US and or international site management is strongly desired. Experience planning and managing NIH funded projects and programs strongly preferred. The position calls for strong and visionary leadership capabilities. The person must be decisive and innovative with very good communication skills. Experience serving as an expert source of information, with a collaborative and flexible style. Ability to work under pressure, with demonstrated capacity to work in partnership with diverse groups while balancing the relative sensitivities are also essential skills for this role. Superior analytic, oral and written communication skills; ability to develop and cogently express an argument; strong negotiating skills; excellent interpersonal skills; creative approach to problemsolving and the achievement of short and long term goals.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you’ll feel good about devoting your time and your talents.
NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
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