Senior Scientist, Vaccine Research Center, NIAID
Deadline: July 27, 2018
The incumbent will direct scientific and technical activities involved in managing state-of-the-art vaccine development activities for the Vaccine Research Center, including supporting the process, analytical, and formulation development of experimental vaccines and therapeutic products for preclinical, Phase I to II, and test-of-concept-efficacy clinical trials to evaluate candidate vaccines and monoclonal antibodies targeting HIV, influenza, malaria, flaviviruses, filoviruses, alphaviruses, and other emerging infections. NIAID is a major research component of NIH and the Department of Health and Human Services (HHS). The incumbent will oversee approximately 125 NIAID and contract staff within the Vaccine Production Program Laboratory and manage an annual budget of approximately $50 million (out of the total VRC budget of approximately $150 million).
The incumbent will have oversight responsibilities for multiple functional areas including 1) oversight of the Vaccine Clinical Materials Program, which is operated through the NIH/NCI Federally Funded Research and Development Center (FFRDC). This includes oversight of a contractor-leased and contractor-operated Vaccine Pilot Plant in Gaithersburg to manufacture under current good manufacturing practice (cGMP) multiple vaccine and other immune modulator candidates originating from the VRC and serving as the government contracting officer’s representative (COR) for the tasks under this contract, which may include external acquisition of clinical materials, or other activities that are investigational new drug (IND)-enabling; 2) management of the Vaccine Production Program Laboratory (VPPL) in Gaithersburg, which focuses on development of novel product and production technologies that will optimize and enable production of vaccines and other immune modulators for clinical trials; 3) management of contracts for procurement of clinical material products, pre-clinical safety testing, and reagent production to facilitate the expedited development of VRC clinical material products; 4) oversight of a Regulatory Science Section to develop strategies to address current FDA requirements, compile regulatory submissions, and develop strategies to move novel technologies from the laboratory to the clinic in a safe and compliant manner; 5) primary responsibility for overseeing VRC contracts with biotechnology companies and being the principal investigator on collaborative research and development agreements (CRADAs) and/or research collaboration agreements (RCAs) with key industrial partners; and 6) full participation in senior level VRC scientific discussions and strategic planning.
The ideal candidate will have a Ph.D. in a relevant scientific discipline and extensive experience in biological drug development leading to licensure, as well as pilot plant and large-scale biopharmaceutical production. The candidate must also have the following: demonstrated experience developing and implementing goals and objectives for the functions of a research program; providing leadership in managing emerging and reemerging biomedical research programs; directing and coordinating scientific and management activities for a clinical site facility; providing recommendations on clinical product approval, proposed platforms, and production timelines; and representing a scientific organization on biomedical research committees, groups, or professional societies.
Salary is commensurate with experience, and a full benefits package is available, including retirement, health and life insurance, long-term care insurance, leave, and Thrift Savings Plan (401k equivalent). To Apply: Submit your curriculum vitae and bibliography by email to Carrie Martin (firstname.lastname@example.org). The deadline for receipt of applications is July 27, 2018. Email email@example.com with questions or for more information about the position. Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere. HHS, NIH, and NIAID are equal opportunity employers.