Organization

Title

Grade

Job Description

HIV Research Branch, Therapeutics Research Program, Division of AIDS

Supervisory Medical Officer (Branch Chief)

15

The incumbent is responsible for the supervision of 4 senior medical officers who in turn oversee more than 40 interventional clinical trials, in which there are currently over 6500 human participants enrolled. These trials are focused on treatment and cure of HIV, are very complex in design and operation, and involve varying degrees of risk depending on the intervention. Some of these trials, such as those which involve gene therapy or immune checkpoint inhibitors, are considered high risk and require the strictest oversight to ensure participant safety as well as to ensure adherence to the highest scientific standards in clinical research. The incumbent plays a critical role in coordination across trials as well as in ensuring prompt and timely communication to regulatory authorities regarding participant safety in these trials. In addition to his/her role in clinical trial oversight, the incumbent plays an important role in identifying research priorities which focus on critical issues affecting the health of persons living with HIV. These priorities will focus research efforts in order to identify safer and more effective treatments as well as cure for HIV, which will ultimately contribute to the end of the AIDS epidemic.

Office for Policy in Clinical Research Operations, Division of AIDS

Medical Officer

14

The incumbent plays a key role in public safety by participating in the oversight of research to treat or prevent HIV/AIDS. DAIDS addresses the national and international research needs created by the advent and spread of the HIV/AIDS epidemic. The incumbent serves as Team Leader for the DAIDS Safety and Pharmacovigilance Team (SPT) and is responsible for directing and overseeing all activities associated with the development and administration of Division-wide standards, policies, and procedures for the safety of DAIDS clinical trials, including trials being performed under approximately 70 active investigational new drug (IND) applications. The incumbent provides expert scientific and medical advice and oversight for safety issues to DAIDS Medical Officers, study teams, and site investigators and works with DAIDS scientific programs to support and safeguard the conduct of the Division’s broad range of domestic and international clinical studies. The work requires a high level of professional competence and has a significant impact on the safe conduct of DAIDS-sponsored clinical trials. The incumbent must possess and exercise broad authoritative medical expertise and knowledge of the regulations, accepted guidelines, and policies governing the safe conduct of clinical trials, as well as professional leadership in ensuring compliance by scientists and investigators involved in conducting DAIDS-sponsored clinical trials. The incumbent thus plays a key role in the public health effort to halt the spread of HIV/AIDS and the HIV/AIDS epidemic.

Complications and Coinfections Research Branch, Therapeutics Research Program, Division of AIDS

Medical Officer

14

The incumbent plays a critical role in public safety by overseeing the initiation and conduct of interventional clinical trials as well as by identifying gaps in our scientific knowledge pertaining to the treatment and prevention of HBV infection in persons infected with HIV. He/she will collaborate with researchers to develop clinical research protocols to address the highest priority gaps as identified and provide direct oversight of ongoing clinical trials to ensure patient safety. Developing safe and effective treatment and prevention strategies will contribute to the safety of the public by reducing the number of persons ever infected with HBV, reducing the number of persons able to transmit the virus, and reducing the complications of HBV infection, namely cirrhosis, end-stage liver disease and liver cancer (hepatocellular carcinoma). The incumbent serves as a senior member of the Complications and Co-Infections Research Branch and represents the Division of AIDS on HBV related clinical research protocol teams and scientific working groups. As a member of the clinical research protocol teams, the incumbent ensures that the protocols has high scientific merit, addresses critical clinical questions, is feasible as proposed and contains the appropriate study participant safety measures. In addition, the incumbent medical officer routinely reviews safety data and interim study reports to asses ongoing safety, feasibility and scientific merit. The incumbent stays abreast of the scientific literature and study product safety information as an ongoing assessment of the studies merits and safety. The responsibilities of the incumbent position in DAIDS is to implement clinical studies with high scientific standards and ensure prompt and timely communication to regulatory authorities, scientific communities and the public research findings to prevent the use of medications that are unsafe and ineffective while at the same time identifying and supporting the use of safe and effective medications.

Therapeutics Research Program, Division of AIDS

Supervisory Medical Officer (Deputy Director)

15

The incumbent is responsible for the oversight of a program portfolio of interventional clinical trials focused on treatment and cure of HIV and associated co-infections such as tuberculosis and viral hepatitis. Currently there are nearly 60 trials with over 13,000 participants in the program portfolio. A high degree of oversight and coordination across the trials and across the program is critical to ensuring participant safety and ensuring adherence to the highest scientific standards. The program portfolio includes a number of high risk trials which require a particularly high degree of oversight. In addition, the incumbent is responsible for determining research priorities for clinical research related to improving the health of people living with HIV. These priorities include the discovery, development and evaluation of novel interventions to diagnose and treat HIV, strategies towards cure or sustained remission of HIV, improved diagnostics, treatment and vaccines for tuberculosis, therapeutics for viral hepatitis, and understanding chronic immune activation and associated non-infectious co-morbidities. These research priorities are ultimately focused on reducing the burden of disease and improving the quality of life of people living with HIV/AIDS.

Complications and Coinfections Research Branch, Therapeutics Research Program, Division of AIDS

Medical Officer

14

The incumbent plays a critical role in public safety by overseeing the initiation and conduct of interventional clinical trials as well as by identifying gaps in our scientific knowledge pertaining to the treatment and prevention of HBV infection in persons infected with HIV. He/she will collaborate with researchers to develop clinical research protocols to address the highest priority gaps as identified and provide direct oversight of ongoing clinical trials to ensure patient safety. Developing safe and effective treatment and prevention strategies will contribute to the safety of the public by reducing the number of persons ever infected with HBV, reducing the number of persons able to transmit the virus, and reducing the complications of HBV infection, namely cirrhosis, end-stage liver disease and liver cancer (hepatocellular carcinoma). The incumbent serves as a senior member of the Complications and Co-Infections Research Branch and represents the Division of AIDS on HBV related clinical research protocol teams and scientific working groups. As a member of the clinical research protocol teams, the incumbent ensures that the protocols has high scientific merit, addresses critical clinical questions, is feasible as proposed and contains the appropriate study participant safety measures. In addition, the incumbent medical officer routinely reviews safety data and interim study reports to asses ongoing safety, feasibility and scientific merit. The incumbent stays abreast of the scientific literature and study product safety information as an ongoing assessment of the studies merits and safety. The responsibilities of the incumbent position in DAIDS is to implement clinical studies with high scientific standards and ensure prompt and timely communication to regulatory authorities, scientific communities and the public research findings to prevent the use of medications that are unsafe and ineffective while at the same time identifying and supporting the use of safe and effective medications.

Maternal, Adolescent, and Pediatric Research Branch, Prevention Sciences Program, Division of AIDS

Supervisory Medical Officer (Branch Chief)

15

The incumbent is responsible for the supervision of 2 senior medical officers and 2 nurse consultants who in turn oversee prevention clinical trials in pediatric populations. The incumbent plays a critical role in coordination across trials as well as in ensuring prompt and timely communication to regulatory authorities regarding participant safety in these trials. In addition to his/her role in clinical trial oversight, the incumbent plays an important role in identifying research priorities which focus on critical issues affecting the health of children living with HIV. These priorities will focus research efforts in order to identify safer and more effective prevention strategies for pregnant women and infants which will ultimately contribute to the end of the AIDS epidemic.