The NIH is the premier biomedical research center for the world. Its 27 Institutes and Centers employ approximately 18,000 employees doing a vast array of jobs, all supporting efforts for a healthy nation. For information on the NIH mission, goals, and Institutes and Centers, visit NIH Overview.
This position is located in the Division of Acquired Immunodeficiency Syndrome (DAIDS) which is responsible for a global research portfolio designed to end the HIV/AIDS epidemic. DAIDS accomplishes this through planning, implementing, managing, and evaluating programs in: 1) fundamental basic laboratory research, 2) discovery and development of therapies and treatment strategies for HIV infection and its complications through basic research and clinical trials, and 3) discovery and development of vaccines, topical microbicides, and other prevention strategies through basic research and clinical trials. For more information, visit http://www.niaid.nih.gov/.
If selected for this position, you will perform the following duties:
- Providing senior level pharmaceutical expertise, guidance, and training for pharmacy issues related to sponsored clinical trials both in the United States and internationally.
- May have responsibility as a Project Officer or Co-Project Officer for a significant research contract which involves developing, coordinating, and administering a broad range of managerial, technical, fiscal, and pharmaceutical activities accompanying the contract and its relationship with pharmaceutical companies, clinical site investigators, and pharmacists.
- Ensuring that sites participating in sponsored clinical trials meet appropriate guidelines and standards regarding investigational agent ordering, storage, dispensing, inventory management and quality assurance.
- Responsible for oversight of the procurement of investigational agents used in sponsored clinical trials, involving the identification of the pharmaceutical manufacturer, negotiation with company representatives, estimation of study product requirements and arrangement for shipment, and review of data agents received for FDA compliance and adherence to specifications prior to their distribution to clinical sites.
- Providing leadership and guidance to protocol team members on the development of the investigational agent section of clinical protocols such as drug dosage, drug interactions and potential toxicities.