The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The NIAID supports resources and services to assist academic, small business and other investigators, including contracts that provide or make available research materials, in vitro drug screening, chemical synthesis including small scale Good Manufacturing Practice (GMP) synthesis, small animal efficacy models, drug formulation, preclinical pharmacology and toxicology, and other discovery and preclinical services to aid the advancement of promising agents from bench to clinics.
Leidos is seeking a Principal Investigator/Project Director to support this contract to provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. Although the focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services, at the discretion of NIAID, these contracts may also be used to advance vaccines, antivirals, and preventive strategies for these and other infectious diseases.
**This position is contingent upon contract award. Which is anticipated in June of 2020**
- Responsible for overall implementation and execution of the contract and key contact for technical aspects of the project.
- Provide overall management and coordination of all contract activities including generation and oversight of timelines, milestones, and task-linked budgets.
- Plan and conduct meetings between NIAID, Task Order personnel, and other project staff.
- Provide planning, initiation, implementation and timely completion of all projects carried out under this contract.
- Select or Lead task orders that will fall into one of the following areas:
- In vitro Testing and Screening Resource for Therapeutics
- Small Animal Models for HIV, HBV, and HCV
- Small Animal Models of Mycobacterium Infection
- Formulation Development and Manufacture of Clinical Dosage Forms
- Preclinical Pharmacology and Toxicology Services
- Reagent Program for HIV and other Infectious Diseases
- Experienced biological scientist (MS with 5+ years of experience or Ph.D. with 3+ years of experience) with a background in HIV, TB, or Hepatitis and/or other related life science backgrounds
- Experience developing protocols, reports, publications, and presentations.
- Excellent written and oral communication skills.
- Experience with in vitro drug screening, Good Manufacturing Practice (GMP) production of therapeutics, small animal efficacy models, drug formulation, preclinical pharmacology and toxicology, or other discovery and preclinical services.
- Familiarity with Food and Drug Administration (FDA) regulatory filings and documentation
- Experience working in the field of HIV, Tuberculosis, Hepatitis B and C.
- Track record of scientific publication on topics related to diagnostics and HIV, Tuberculosis, and Hepatitis B and C.
External Referral Bonus:Ineligible
Potential for Telework:No
Clearance Level Required:Public Trust
Travel:Yes, 10% of the time
Scheduled Weekly Hours:40
Job Family:Proj and Prog Management
Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 33,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit www.Leidos.com.
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