Study Director - IR-4 Project

The IR-4 Project is a nationally and internationally recognized Federal-State partnership that facilitates the registration of safe and effective chemical, biological, and other pest management technologies for specialty crop producers. Specialty crops-including fruits, vegetables, nuts, herbs, spices, ornamentals, and nursery crops-represent high-value sectors of U.S. agriculture but often lack sufficient market incentives for private industry to independently pursue registrations for these crops.

As the nation's primary program supporting pest management solutions for specialty crops, IR-4 plays a critical role in ensuring growers have access to the tools needed to produce safe, abundant, and economically viable crops. Without IR-4, many specialty crop growers would have limited access to crop protection products, resulting in reduced productivity, increased pest losses, and fewer management options.

IR-4 operates through a nationwide network consisting of four regional programs, multiple USDA and university partners, more than 20 public research farms, and analytical laboratories located throughout the United States. The program coordinates research conducted by approximately 125 scientists and technical specialists across the country.

IR-4 Project Headquarters is part of North Carolina State University and located in Centennial Campus in Raleigh, North Carolina, within the Venture IV Building. Headquarters provides national leadership, scientific oversight, regulatory strategy, data management, and Good Laboratory Practice ( GLP) compliance for the program's research portfolio and regulatory submissions.

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The Study Director position will report directly to the IR-4 Submission Manager and Senior Study Director. This position will be an integral part of the IR-4 Project Headquarters unit. Duties of this position include, but are not limited to:

Protocol Development: Provide technical direction of research associated with IR-4 Project Magnitude of the Residue Studies that are performed by cooperating university and government scientists at various locations throughout North America. All aspects of the study must follow the provisions of the United States Environmental Protection Agency's Federal Good Laboratory Practice (Chapter 40- Code of Federal Regulations, Part 160) regulations. Specific duties include development of approximately 10 national research protocols (study plans) annually for IR-4 Project sanctioned studies. Responsible for drafting and developing protocols after extensive consultation with owners of the products, study scientists and IR-4 Project biologists. Must be able to balance needs of stakeholder suggestions in the development of the final product. Protocols must be prepared and authorized well in advance of target dates for research.

Study Coordination: Direct and manage approximately 60 on-going IR-4 sponsored residue research studies in various phases of completion. An average IR-4 residue study involves seven field trials and one analytical phase performed at various research facilities. This means that the Study Director is responsible to direct the research of 400 research projects. As autonomous director of the projects, the study director must assist scientists to successfully plan, conduct and report on IR-4 sponsored research with chemical and bio-based pesticides on specialty crops. Must promptly evaluate and approve all proposed modifications from the authorized research protocol. Must keep track of status of active studies, including knowledge when critical phases of research are planned/performed, when residue samples are shipped to the analytical laboratory, when samples are analyzed by the laboratory and when research reports are received. Communicate with numerous individuals to maintain involvement in all facets of the research. Also responsible for critical review and scientific assessment of the data/data reports associated with the studies in a timely manner to ensure that the research was performed appropriately and according to protocol. Review includes the test substance application rates, application timing of the test substance collection of adequate residue samples, and appropriate storage of samples before and during shipping to the laboratory, review of the analytical data including the analytical summary report. All findings of the Quality Assurance unit must be promptly addressed.

Data package development: Independently develop approx. 6 "submission ready" data packages annually utilizing established national ( USEPA- OPPTS GUIDELINES) and/or international standards (e.g. UN FAO-Joint Meeting on Pesticide Residues). Expectations are that the incumbent:

Applicant required documents: Cover Letter, Resume/CV, and Contact Information for at least 3 Professional References.

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