HJF is seeking a Vice President to lead a newly created portfolio focused primarily on providing executive leadership of HJF's component supporting DoD's PEPFAR program, with significant additional responsibility to lead HJF's efforts in HJF sponsored regulated clinical trials. This latter area of responsibility covers FDA IND and IDE studies. The former falls under PEPFAR activities that are managed by the Military HIV Research Program (MHRP) under the Center for Infectious Diseases (CIDR) at the Walter Reed Army Institute of Research (WRAIR).

Under the supervision of HJF's President and CEO, the incumbent will provide direct oversight and management of HJF's PEPFAR award with primary support from the Director of Global Health and PEPFAR Operations. The incumbent is also responsible for contributing to HJF strategic development and oversight of FDA IND and IDE studies sponsored by HJF, collaborating closely with HJF's SVP/Chief Medical Officer. The incumbent will serve as principal investigator on assigned clinical trials, responsible for all elements of execution. In this capacity, the incumbent will supervise and direct the planning, design, implementation, oversight, and analysis of clinical research activities. Additionally, the incumbent will contribute to development of research opportunities, focusing on international sites, leveraging PEPFAR, and collaborating closely with the HJFMRI Director for Research - Africa and the Global ID and Global Operations portfolio personnel. The VP will also identify opportunities for leveraging the capabilities available for other CONUS and OCONUS investigators, to include those under the Domestic Operations and USU Portfolios. The incumbent will be responsible for ensuring adherence to appropriate safety and regulatory requirements, accuracy of documentation on participants' records for clinical trials, and confidentiality in all aspects of the clinical care and treatment and clinical research process. The incumbent will work with HJF staff, US government collaborators, clinical research teams, and other stakeholders as part of a cohesive team to meet mission objectives.

Responsibilities:

50% Effort

Incumbent oversees PEPFAR activities that are funded by a dedicated cooperative agreement implemented by HJF on behalf of the US Army. As Program Director of the cooperative agreement, the incumbent provides overall leadership of the program with an emphasis on medical management and corporate relations with DoD, State Department, and host national agencies.

20% Effort

• Incumbent coordinates and leads clinical research activities focused on leveraging PEPFAR program assets. Works with the Global ID portfolio on engagements with external collaborators and other USG agencies. Engages with other HJF portfolios in leveraging capabilities under their respective purview that present unique opportunities for expansion of CONUS and OCONUS clinical research. As a potential protocol chair, serving as principal investigator, associate investigator or advisor, designs, directs, and participates in clinical research activities according to the research mission.

25% Effort

• Incumbent works with the HJF CMO to develop HJF's capabilities for being Sponsor lead for regulated studies. In this capacity, the incumbent identifies appropriate support needed, then leads a small group of SMEs to support HJF as IND or IDE sponsor representative, working closely with the Office of Regulatory Affairs and Research Compliance, the Tech Transfer team, Business Development and the other HJF portfolios to ensure appropriate risk management and full compliance measures are in place for HJF in the role of regulatory sponsor.

5% Effort

• Incumbent provides consultation and supervises the management of research participants in international protocols.
• Analyzes data and prepares scientific papers for presentation at local, national, and international meetings and for publication in peer-reviewed medical and scientific periodicals, while also supervising and assisting junior investigators, site investigators, trainees, and collaborators in these pursuits.
• Provides clinical and vaccine development expertise to promote participant safety and study integrity by serving on Protocol Safety Review Teams (PSRTs), Study Monitoring Committees (SMCs), Data Safety Monitoring Boards (DSMBs), and in other roles, as directed.
• Promotes the national and international visibility of research activities by actively engaging the scientific community through involvement in professional society activities, participation in peer review processes, membership on editorial boards for scientific periodicals, and other related undertakings.
• Supports scientific misconduct evaluations conducted by HJF under the supervision of the CMO.

Minimum Education: MD/DO required.

Minimum Experience/Training Requirements: Physician IV: A minimum of 15 or more years of experience required with at least 5 years in PEPFAR and 10 years in clinical research and regulatory activities.

Required Knowledge, Skills and Abilities: Thorough knowledge of processes, procedures, and techniques necessary for performing PEPFAR care, treatment, and clinical research tasks; knowledge of medical science and the development of clinical research programs to support product development; experience in the design of clinical research trials; ability to communicate effectively; ability to make effective presentations and publish; knowledge of applicable US regulations governing the conduct of medical research within DoD and under the auspices of the FDA; excellent verbal, written (publications) and interpersonal communication skills; and the willingness and regular ability to travel to OCONUS research sites on multiple occasions and for protracted periods.

Physical Capabilities: Bending, standing, and sitting; able to tolerate intercontinental travel.

Travel: International travel is required for this position. Weekend travel will be required. International travel locations include, but are not limited to, Kenya, Tanzania, Nigeria, and Thailand. 35% of time is expected.

Supervisory Responsibilities: May supervise clinicians, scientists, researchers, administrators, students, or other support staff.

Work Environment: This position takes place in an office, field, clinic, clinical trials unit or hospital environment.

Work Arrangement: This is a hybrid work environment with flexibility to telework, as appropriate.

Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.